Regulations on Supervision and Administration of Medical Devices (Revised in 2017)

Order of the State Council of the People's Republic of China No.680

May 4, 2017

(Promulgated by the Order of the State Council of the People's Republic of China No.276 on January 4, 2000; revised and adopted at the 39th executive meeting of the State Council on February 12, 2014; and revised by the Decision of the State Council on Revising the Regulations on the Supervision and Administration of Medical Devices on May 4, 2017)

Chapter I General Provisions

Article 1 The Regulations on the Supervision and Administration over Medical Devices (hereinafter referred to as the "Regulations") are hereby formulated for the purposes of ensuring the safety and effectiveness of medical devices and guaranteeing the human health and safety of lives.

Article 2 Activities in terms of development, manufacture, operation and utility as well as supervision and administration of medical devices within the territory of China shall be subject to these Regulations.

Article 3 The food and drug supervision and administration department under the State Council shall be responsible for the supervision and administration of medical devices throughout the country. The relevant departments of the State Council shall be responsible for the supervision and administration related to medical devices within their scope of duties respectively.
The food and drug supervision and administration departments of the local people's governments at county level or above shall be responsible for the supervision and administration of medical devices within their respective administrative regions. The relevant departments of the local people's governments at county level or above shall be responsible for the supervision and administration related to medical devices within their respective scope of duties.
The food and drug supervision and administration department under the State Council shall coordinate with the relevant departments of the State Council in implementing the national industrial plans and policies on medical devices.

Article 4 The State adopts classified administration of medical devices by risk level.
Class I medical devices with low risk, whose safety and effectiveness can be guaranteed through routine administration.
Class II medical devices with medium risk, whose safety and effectiveness can be ensured by strict control and administration.
Class III medical devices with high risk, whose safety and effectiveness can be ensured by strict control and administration through special measures.
To evaluate the risk level of a medical device, expected purpose, structural features, method of application and other factors thereof shall be considered.
The food and drug supervision and administration department under the State Council shall be responsible for working out classification rules and contents of classified medical devices, and timely analyze and assess, according to the production, operation and use of medical devices, the change in risk of medical devices and then adjust the classification contents. When formulating and adjusting the classification contents, the food and drug supervision and administration department under the State Council shall fully listen to the opinions of producing and operating enterprises, users and industrial organization of medical devices and refer to the international practices for classification of medical devices. Classification contents of medical devices shall be disclosed to the public.

Article 5 The research and development of medical devices shall follow the principles of safety, effectiveness and conservation. The state encourages the research and innovation of new medical devices, gives full play of the role of market mechanism, drives the promotion and application of new technology of medical devices, to promote the development of medical device industry.

Article 6 Medical devices shall comply with the compulsory national standards for medical devices; where no compulsory national standards are provided, the compulsory industrial standards for medical devices shall be complied with.
Contents of disposable medical devices shall be prepared, adjusted and published by the food and drug supervision and administration department under the State Council in concert with the competent health and family planning department of the State Council. Reusable medical devices whose safety and effectiveness can be ensured shall not fall into the disposable contents. For the reusable medical devices whose safety and effectiveness can be ensured after the improvement of design, production process and sterilization and disinfection technology shall be moved out of the disposable classification contents.

Article 7 Industrial organizations of medical devices shall strengthen industry self-regulation, promote the construction of credit system, urge enterprises to legally conduct production and operation activities and instruct the enterprises to be honest and trustworthy.

Chapter II Registration and Record-filing of Medical Devices

Article 8 For Class I medical devices, the record-filing management shall be implemented, while for Class II and Class III ones, the registration management shall be implemented.

Article 9 For record-filing of Class I medical devices and application for registration of Class II and Class III medical devices, the following materials shall be submitted:
1. materials for analysis of product risks;
2. technical requirements for products;
3. products inspection report;
4. clinical assessment materials;
5. products specification and label sample;
6. quality management system documents related to the research and production of products; and
7. other materials necessary for proving the safety and effectiveness of products.
The applicant for registration or filing of medical devices shall be responsible for the authenticity of materials submitted.

Article 10 In the case of the record-filing for Class I medical devices, an applicant shall submit the filing materials to the food and drug supervision and administration departments of the people's governments of the cities divided into districts where the applicant is located. The products inspection report contained in the record-filing materials may be the self-inspection report; clinical assessment materials exclude the clinical trial report but may be the materials proved to be safe and effective by data obtained through documents and clinical use of the similar products.
For overseas manufacturers who export Class I medical devices to China, it is the representative institutions set up by such manufacturers in China or the enterprise legal persons in China designated by such manufacturers who act as agents that shall submit to the food and drug supervision and administration departments under the State Council the filing materials and supporting documents that the competent departments in the country (region) where the applicant for filing is located allow the listing for sales of such medical devices.
Where there is any change in matters stipulated in the filing materials, the filing for change shall be made with the original filing department.

Article 11 In the case of the application for Class II medical devices registration, the applicant shall submit the registration application materials to the food and drug supervision and administration department of the people's government in the province, autonomous region or municipality directly under the Central Government where the applicant is located. In the case of the application for registration of Class III medical devices, the applicant for registration shall submit the registration application materials to the food and drug supervision and administration departments under the State Council.
For overseas manufacturers who export Class II and Class III medical devices to China, it is representative institutions set up by such manufacturers in China or enterprise legal persons in China designated by such manufacturers as agents that shall submit to the food and drug supervision and administration department under the State Council the registration application materials and supporting documents in which the local competent departments in the country (region) allow such medical devices to be marketed.
The product inspection reports in the registration application materials for Class II and Class III medical devices shall be the inspection reports issued by the medical device inspection institutions; clinical assessment materials shall include the clinical trial reports with the exception of those for medical devices which are exempt from clinical trial in accordance with the provisions of Article 17 hereof.

Article 12 The food and drug supervision and administration department that accepts the registration application shall, within three working days after its acceptance, transfer the registration application materials to technical evaluation institutions, who shall, upon the completion of technical evaluation, submit its evaluation opinions to the food and drug supervision and administration department.

Article 13 The food and drug supervision and administration department that accepts the registration application shall make a decision within 20 working days after receipt of evaluation opinions. For the medical devices that meet the requirements of safety and effectiveness, the registration shall be approved and a medical device registration certificate shall be granted; for the medical devices that fail to meet such requirements, the registration shall be refused and written reasons shall be given.
Where the food and drug supervision and administration department under the State Council finds it necessary to check the quality management system when organizing the technical evaluation on imported medical devices, it shall organize the technical inspection institutions of the quality management system to check the quality management system.

Article 14 For registered Class II and Class III medical devices, where any substantial change in their design, raw materials, production process, applicable scope and usage has potential impact on the safety and effectiveness of such medical devices, the registrant shall apply to the original registration department for handling procedures for change of registration; where any non-substantial change does not affect the safety and effectiveness of such medical devices, the registrant shall report the change to the original registration department for record-filing.

Article 15 The medical device registration certificate is valid for five years. Where the period of validity therefor needs to be extended upon the expiration, an application for such extension shall be made to the original registration department six months before the expiration.
Except for the circumstances stipulated in Paragraph 3 hereof, the food and drug supervision and administration department that receives the application shall make the decision to approve the extending before the expiration of the medical device registration certificate. If the decision fails to be made within the time limit, it is deemed as an approval.
An application for registration renewal shall not be approved under any of the following circumstances:
1. the registrant fails to apply for extending the registration within the specific time limit;
2. where the compulsory standards for medical devices have been revised, and the medical devices applied for extending the registration cannot meet the new requirements; and
3. for medical devices in urgent demand used for treating rare diseases and responding to emergent public health events, the matters stipulated in the medical device registration certificate fail to be finished within the specific time limit.

Article 16 In the case of medical devices newly developed but not included in the classification contents, an applicant may directly apply for product registration in accordance with the provisions on product registration for Class III medical devices hereof and also may determine the class of products according to the classification rules and apply for registration or make record-filing in accordance with the provisions hereof after applying to the food and drug supervision and administration department under the State Council for confirmation of the class.
In the case of medical devices that directly applied for product registration for Class III medical devices, the food and drug supervision and administration department under the State Council shall, according to the risk level, determine their class and then timely include in the classification contents the medical devices whose registration is approved. Where the class confirmation is applied for, the food and drug supervision and administration department under the State Council shall, within 20 working days after accepting the application, determine the class of the medical devices and inform the applicant of the result.

Article 17 For product filing for Class I medical devices, no clinical trial is needed. While for application for the product registration for Class II and Class III medical devices, a clinical trial shall be made. However, a clinical trial may be exempt under any of the following circumstances:
1. the medical devices have clear working mechanism, established design and mature production process and the same kind of medical devices that have been listed have been used for many years without material bad records and change of general purpose thereof;
2. the medical devices are proved to be safe and effective through non-clinical evaluation; and
3. the medical devices are proved to be safe and effective through analysis and evaluation on the data obtained from the clinical trial or clinical use of the same kind of medical devices.
The contents of medical devices exempt from clinical trial shall be formulated, adjusted and promulgated by the food and drug supervision and administration department under the State Council.

Article 18 Clinical trials for medical devices shall, according to the requirements of quality management standards on clinical trials for medical devices, be carried out in the qualified clinical trial institutions and, be record-filed with the food and drug supervision and administration departments of the people's government in the province, autonomous region or municipality directly under the Central Government where the entity requesting for clinical trials is located. The food and drug supervision and administration department that accepts the record-filing for clinical trials shall report the record-filing to the food and drug supervision and administration department and health and family planning department at the same level of the place where the clinical trial institution is located.
Medical devices clinical trial institutions perform the record-filing management. Conditions that shall be met, as well as the record-filing management measures and quality management standards on clinical trials for medical devices clinical trial institutions, shall be formulated and promulgated by the food and drug supervision and administration department of the State Council in concert with the health and family planning department of the State Council.

Article 19 Where the clinical trial of Class III medical devices poses high risk to human beings, it shall be approved by the food and drug supervision and administration department under the State Council. The contents for Class III medical devices with high risk to human beings shall be formulated, adjusted and promulgated by the food and drug supervision and administration department under the State Council.
When reviewing the clinical trial, the food and drug supervision and administration department under the State Council shall conduct comprehensive analysis of the equipment, professionals and other conditions of the institutions proposing to undertake the clinical trial of medical devices and the risk level of medical devices, implementation scheme for clinical trial and analysis report for comparison of clinical benefit and risk. The approval of the clinical trial shall be reported to the food and drug supervision and administration department and the health and family planning department of the people's government in the province, autonomous region or municipality directly under the Central Government where the applicant for clinical trial and clinical trial institutions are located.

Chapter III Production of Medical Devices

Article 20 To engage in the production of medical devices, the enterprise concerned shall meet the following requirements:
1. having the production place, environmental conditions, production equipment and professional technicians that meet the needs of the medical devices to be produced;
2. having the institutions or professionals and the inspection equipment for the quality inspection of the medical devices to be produced;
3. having management system to ensure the quality of medical devices;
4. having after-sale service that meet the needs of the medical devices to be produced; and
5. requirements provided for in documents on product development and production process.

Article 21 Where engaging in production of Class I medical devices, the producing enterprise shall make a record-filing with the food and drug supervision and administration department of the people's government of the city divided into districts where the producing enterprise is located and submit the supporting materials that meet the requirements of Article 20 hereof.

Article 22 Where engaging in production of Class II and Class III medical devices, the producing enterprise shall apply to the food and drug supervision and administration department of the people's government in the province, autonomous region or municipality directly under the Central Government where the producing enterprise is located for production license and submit the supporting materials that meet the requirements of Article 20 hereof as well as the registration certificates for the medical devices produced.
The food and drug supervision and administration department that accepts the application for production license shall, within 30 working days after its acceptance, review the application materials and check them according to the requirements set forth in quality management standards for medical devices production by the food and drug supervision and administration department under the State Council. For the qualified medical devices, the license shall be approved and a medical device production license shall be issued; for the medical devices that fail to meet such conditions, the license shall be refused and written reasons shall be given.
The medical device production license is valid for five years. Where the period of validity for the license needs to be extended upon the expiration, the procedures for such extension shall be handled in accordance with the provisions of laws related to administrative licensing.

Article 23 Such matters that affect the safety and effectiveness of medical devices as the design and development, conditions for production equipment, purchasing of raw materials, control of production process of medical devices as well as institutional setup and personnel allocation of the enterprise shall be explicitly stipulated in the quality management standards for medical devices production.

Article 24 A medical device manufacturer shall, according to the requirements of the quality management standards for medical device production, set up and improve the quality management system that meets the needs of the medical devices produced and ensure the effective operation thereof; it shall, in strict accordance with the registered and record-filed technical requirements for products, organize the production to ensure that the manufactured medical devices comply with the compulsory standards and the registered and record-filed technical requirements therefor.
The medical device manufacturer shall regularly inspect the operation of the quality management system by itself and submit its self-inspection report to the food and drug supervision and administration department of the people's government in the province, autonomous region or municipality directly under the Central Government where the producing enterprise is located.

Article 25 Where any change in the production conditions of a medical device manufacturer causes a failure to meet the requirements of the quality management system for medical devices, the manufacturer shall adopt rectification measures immediately; where such change may affect the safety and effectiveness of medical devices, the manufacturer shall immediately stop its production and report to the food and drug supervision and administration department of the people's government at county level where the manufacturer is located.

Article 26 Medical devices shall use general names. And the general name shall comply with the naming rules for medical devices formulated by the food and drug supervision and administration department under the State Council.

Article 27 Medical devices shall be attached with instructions and labels whose contents shall be consistent with those registered or record-filed.
The instructions and labels of medical devices shall indicate the following matters:
1. general name, model and specification;
2. name, domicile, production address and contact information of the producing enterprise;
3. serial number of the technical requirements for products;
4. production date and service life or expiration date;
5. product performance, main structure and applicable scope;
6. contraindications, points for attention and other contents necessary to be warned or reminded;
7. installation and operation instructions or drawings;
8. maintenance method and special storage condition and method; and
9. other contents that shall be stated as required by the technical requirements for products.
For Class II and Class III medical devices, number of the medical device registration certificate and the name, address and contact information of the registrant of the medical devices shall be also indicated.
For the medical devices used by the consumers independently, special instructions for safe use shall be also included.

Article 28 For the medical devices produced by entrust, the entrusting party shall be responsible for the quality of entrusted medical devices. The entrusted party shall be the medical device manufacturer that complies with the provisions hereof and has corresponding production conditions. The entrusting party shall strengthen the management of the production by the entrusted to ensure the production is conducted according to statutory requirements.
The implantable medical devices with high risk shall not be entrusted to produce. The specific contents shall be produced, adjusted and promulgated by the food and drug supervision and administration department under the State Council.

Chapter IV Operation and Use of Medical Devices

Article 29 To engage in the operation of medical devices, an operating enterprise shall have premises and storage conditions that match the business scale and scope, and have a quality management system and be equipped with quality management institutions or personnel that meet the needs of the operated medical devices.

Article 30 Where engaging in operation of Class II medical devices, an operating enterprise shall make a record-filing with the food and drug supervision and administration department of the people's government of the city divided into districts where the operating enterprise is located, and submit the supporting materials that meet the requirements of Article 29 hereof.

Article 31 Where engaging in operation of Class III medical devices, an operating enterprise shall apply to the food and drug supervision and administration department of the people's government of the city divided into districts where the operating enterprise is located for business license and submit the supporting materials that meet the requirements of Article 29 hereof.
The food and drug supervision and administration department that accepts the application for operation license shall, within 30 working days after its acceptance, review the application materials and organize an examination if necessary. For the medical devices that meet the conditions stipulated, the license shall be approved and a medical device operation license shall be granted; for the medical devices that fail to meet such conditions, the license shall be refused and written reasons shall be given.
The medical device operation license is valid for five years. Where the period of validity for the license needs to be extended upon the expiration, the procedures for such extension shall be handled in accordance with the provisions of laws related to administrative licensing.

Article 32 When the operating enterprises of medical devices or users purchase medical devices, they shall check the qualification of suppliers and the eligible supporting materials of medical devices and establish an entry inspection record system. The operating enterprises engaging in wholesale business of Class II and Class III medical devices and retail business of Class III medical devices shall establish a sales record system.
Matters to be recorded include:
1. name, model, specification and quantity of medical devices;
2. batch number, period of validity and sales date of medical devices;
3. name of the producing enterprise;
4. name, address and contact information of their supplier or purchaser; and
5. numbers of supporting documents of relevant license, etc.
The entry inspection record and sales record shall be real and be kept during the period specified by the food and drug supervision and administration department under the State Council. The state encourages the record by means of advanced technology.

Article 33 The transportation and storage of medical devices shall comply with the requirements of instructions and labels of medical devices; if there are special requirements on temperature, humidity and other environmental conditions, corresponding measures shall be taken to ensure the safety and effectiveness of medical devices.

Article 34 The users of medical devices shall have storage places and conditions that meet the needs of the varieties and quantities of the currently used medical devices. The users of medical devices shall strengthen the technical training for their staff and instruct them to use the medical devices according to requirements in product specifications and technical operation standards.
The users of medical devices shall comply with the allocation plan on large-sized medical equipment formulated by the health and family planning department of the State Council when they are equipped with large-sized medical equipment, which shall match the functional orientation and the clinical service requirements. They shall possess corresponding technical conditions, supporting facilities and are staffed with professional technicians who have corresponding qualifications and ability, and be approved by the health and family planning departments of the people's governments above the provincial level, and have obtained license for allocation of large-sized medical equipment.
Administrative measures for large-sized medical equipment allocation shall be formulated by the health and family planning department of the State Council in concert with relevant departments of the State Council. The catalogue of large-sized medical equipment shall be proposed by the health and family planning department of the State Council in consultation with relevant departments of the State Council, and be implemented after approved by the State Council.

Article 35 The reused medical devices shall be handled by the users of medical devices in accordance with the provisions on sterilization and management stipulated by the competent health and family planning department of the State Council.
The disposable medical devices shall not be reused and the used ones shall be destroyed and recorded in accordance with the relevant provisions of the state.

Article 36 The users of medical devices shall, according to the requirements of product instructions, check, inspect, calibrate and maintain the medical devices that regularly need doing so and make records, timely analysis and evaluation to make sure the medical devices are in a good condition and to guarantee the quality in use; for large medical devices with long use life, files for use of such medical devices shall be established one by one and such matters as use, maintenance, transfer and actual use life shall be recorded. The retention period for records shall be no less than five years after the expiration of specified use life of medical devices.

Article 37 The users of medical devices shall carefully keep the source information of Class III medical devices purchased and ensure the traceability of such information.
Where large medical devices and implantable and interventional medical devices are used, such information as name and key technical parameters of medical devices and essential information closely related to quality and safety for use shall be recorded in medical history and other relevant records.

Article 38 Where any medical device in use is found to have potential safety hazards, the users of medical devices shall immediately stop to use it and require the producing enterprise or other institutions responsible for product quality to conduct examination and maintenance; if the medical device fails to meet the safety standards for use after the examination and maintenance, it shall no longer be used.

Article 39 The food and drug supervision and administration department and the competent health and family planning department shall exercise their respective duties to supervise and administer the quality and use of medical devices in use.

Article 40 The operating enterprise and user of medical devices shall not operate and use the expired, invalid and obsolete medical devices without eligible supporting materials that fail to be registered in accordance with the law.

Article 41 For transfer of medical devices in use between the users of medical devices, the transferor shall ensure the safety and effectiveness of the medical devices transferred, and no expired, invalid, obsolete and unqualified medical devices shall be transferred.

Article 42 Imported medical devices shall be those registered or record-filed in accordance with the provisions of Chapter II hereof.
Imported medical devices shall be attached with Chinese instructions and Chinese labels, which shall comply with the provisions hereof and requirements of the relevant compulsory standards. The instructions shall clearly indicate the origin of medical devices and name, address and contact information of the agent. Medical devices without Chinese instructions and Chinese labels or those whose instructions and labels do not comply with the provisions of this Article shall not be imported.

Article 43 Entry-exit inspection and quarantine institutions shall carry out inspection on imported medical devices in accordance with the law; where the medical devices are unqualified, they shall not be imported.
The food and drug supervision and administration department under the State Council shall timely report to the national entry-exit inspection and quarantine department the registration and record-filing of imported medical devices. The entry-exit inspection and quarantine institutions where the import port is located shall timely report to the food and drug supervision and administration department of the people's government of the city divided into districts where the import port is located the customs clearance of imported medical devices.

Article 44 An exporter of medical devices shall make sure that its exported medical devices meet the requirements of the importing country (region).

Article 45 The advertisement of medical devices shall be real and legal and shall not include any false, exaggerate and misleading contents.
Advertisement of medical devices shall be examined and approved by the food and drug supervision and administration department of the people's government in the province, autonomous region or municipality directly under the Central Government where the producing enterprise or the agent of imported medical devices is located. Approval documents for such advertisement shall be obtained. Where the advertiser publishes the advertisement of medical devices, it shall check the approval documents and the authenticity thereof in advance; no advertisement of medical devices with approval documents not obtained, authenticity thereof not proved or contents inconsistent with approval documents shall be published. The food and drug supervision and administration department of the people's government in the province, autonomous region or municipality directly under the Central Government shall disclose and timely update the advertisement list of approved medical devices and approved advertising contents.
Where the food and drug supervision and administration department of the people's government at provincial level or above orders to suspend the production, sales, importing and use of the medical devices, no such medical devices shall be advertised during the period of suspension.
The examination measures for advertisement of medical devices shall be prepared by the food and drug supervision and administration department under the State Council in concert with the administrative department for industry and commerce under the State Council.

Chapter V Handling of Adverse Events and Recall of Medical Devices

Article 46 The state shall set up monitoring system for adverse events of medical devices to collect, analyze, evaluate and control such adverse events in a timely manner.

Article 47 The producing and operating enterprise or users shall monitor the adverse events of medical devices produced, operated or used by them; if any adverse event or suspicious event of medical devices is found, it shall be reported to the monitoring technical institutions of adverse events of medical devices in accordance with the provisions of the food and drug supervision and administration department under the State Council.
Any unit and individual who finds any adverse event or suspicious event of medical devices is entitled to report to the food and drug supervision and administration department or the monitoring technical institutions of adverse events of medical devices.

Article 48 The food and drug supervision and administration department under the State Council shall strengthen the construction of monitoring information network for adverse events of medical devices.
The monitoring technical institutions of adverse events of medical devices shall intensify the monitoring of adverse events of medical devices and actively collect the information of adverse events; if any adverse event is found or reported, the monitoring technical institutions shall timely check, investigate, analyze and evaluate the adverse event and propose to the food and drug supervision and administration department and the competent health and family planning department with handling suggestions.
The monitoring technical institutions of adverse events of medical devices shall make its contact information public for the convenience of reporting the adverse events of medical devices by the producing and operating enterprises or users.

Article 49 The food and drug supervision and administration department shall, according to the evaluation results of adverse events of medical devices, take such control measures as publishing warning information and ordering to suspend the production, sales, importing and use in a timely manner.
The food and drug supervision and administration department of the people's government at provincial level or above shall, in concert with the competent health and family planning department and the relevant departments at the same level, organize a timely investigation on and deal with the adverse events of medical devices resulting in sudden serious damage or death, or serious damage to or death of masses, and strengthen the monitoring on the medical devices of the same kind.

Article 50 The producing and operating enterprises or users shall be cooperative in investigation of adverse events of medical devices carried out by the monitoring technical institutions of adverse events of medical devices and the food and drug supervision and administration department.

Article 51 The food and drug supervision and administration department of the people's government at provincial level or above shall reevaluate the registered and filed medical devices under any of the following circumstances:
1. there is any change in recognition of safety and effectiveness of medical devices with the development of scientific research;
2. the results of monitoring and evaluation of adverse events of medical devices state that the medical devices may have defects; and
3. other circumstances necessary for reevaluation stipulated by the food and drug supervision and administration department under the State Council.
Where the results of reevaluation suggest that safety and effectiveness of the registered medical devices cannot be guaranteed, the medical device registration certificate shall be cancelled by the original issuing department and such cancellation shall be published to the public. The medical devices with medical device registration certificate cancelled shall not be produced, imported, operated or used.

Article 52 Where a producing enterprise of medical devices finds that the medical devices produced by it do not meet the compulsory standards or registered or record-filed technical requirements for products or exist other defects, it shall immediately stop the production and require the relevant producing and operating enterprises, users and consumers to stop to operate and use such medical devices, recall the medical devices already sold on the market, take remedial measures or destroy such defective devices, record the relevant situation and release the relevant information, and report to the food and drug supervision and administration department and the competent health and family planning department the recall and handling of medical devices.
Where an operating enterprise of medical devices finds that the medical devices operated by it fall into any circumstance stated in the preceding paragraph, it shall immediately stop the operation, inform the relevant producing and operating enterprises, users and consumers and make the relevant records. Where the producing enterprise of medical devices thinks such devices fall into the category of those necessary for recall in accordance with the provisions of the preceding paragraph, such devices shall be immediately recalled.
Where a producing and operating enterprise fails to recall the medical devices or suspend its operation in accordance with the provisions of this Article, the food and drug supervision and administration department may order it to recall the medical devices or suspend its operation.

Chapter VI Supervision and Examination

Article 53 The food and drug supervision and administration department shall strengthen the supervision and examination on the registration, record-filing, production, operation and use, and focus the supervision and examination on the following matters:
1. whether the producing enterprise of medical devices organizes the production according to the registered or record-filed technical requirements for products;
2. whether the quality management system of the producing enterprise of medical devices keeps effective operation; and
3. whether the producing and operating conditions of the producing and operating enterprises of medical devices consistently meet the statutory requirements.

Article 54 During the supervision and examination, the food and drug supervision and administration department is entitled to:
1. conduct an inspection and a sampling on the site;
2. look up, copy, seal up or detain the relevant contracts, notes, account books and other relevant materials;
3. seal up or detain the medical devices that fail to meet the statutory requirements, illegally used spare and accessory parts and raw materials, and tools and equipment for illegally producing medical devices; and
4. seal up the places for production and operation of the medical devices in violation of the provisions hereof.
Where the food and drug supervision and administration department carries out supervision and examination, it shall show its law enforcement certificate and keep confidential of trade secrets of the examined unit.
The relevant units and individuals shall be cooperative in the supervision and examination by the food and drug supervision and administration department and shall not conceal any relevant issue.

Article 55 For medical devices that are harmful to human beings or are proved to probably jeopardize the health of human beings, the food and drug supervision and administration department may take urgent control measures as suspending production, importing, operation and use.

Article 56 The food and drug supervision and administration department shall reinforce the random inspections over the medical devices produced, operated and used by enterprises producing, operating and using them. No inspection fees or other expenses shall be charged for the random inspections, and the expenses required shall be included in the budget of government at the same level. The food and drug supervision and administration department of the people's government at the provincial level or above shall, according to the results of random inspections, publish the announcement on the quality of medical devices in a timely manner.
The health and family planning department shall carry out supervision and evaluation on the using conditions of large-sized medical equipment, and once discovering any improper operation, or situations such as excessive examination, excessive treatment, etc. that are relevant to large-sized medical equipment, the health and family planning department shall immediately correct them, and handle them in accordance with the law.

Article 57 Qualification identification by the medical device inspection institutions implements unified management in accordance with the relevant provisions of the state. Only the supervision and administration department certificated and recognized by the State Council may, in concert with the food and drug supervision and administration department under the State Council, inspect the medical devices.
Where the food and drug supervision and administration department needs to inspect the medical devices during the law enforcement, it shall entrust qualified medical device inspection institutions to do so and pay the relevant expenses.
Where the party concerned has any objection to the inspection conclusion, it may, within seven working days after receipt of it, select a qualified medical device inspection institution to re-inspect the devices. Such medical device inspection institution that conducts the re-inspection shall provide a conclusion within the time limit stipulated by the food and drug supervision and administration department under the State Council. The conclusion of the re-inspection shall be final.

Article 58 Where the medical devices that probably have hazardous substances or whose deign, raw materials and production process are changed without authorization and that have potential safety hazards cannot be inspected through inspection items and inspection methods specified in the national standards and industrial standards for medical devices, the medical device inspection institution may supplement inspection items and inspection methods to conduct the inspection; The inspection conclusion acquired by use of supplementary inspection items and inspection methods shall, upon approval of the food and drug supervision and administration department under the State Council, be the basis for identification of quality of medical devices by the food and drug supervision and administration department.

Article 59 The food and drug supervision and administration department of the people's government of the city divided into districts and at county level shall enhance the supervision and examination on the advertisement of medical devices; if finding any advertisement of medical devices that is disapproved or whose contents approved are falsified, it shall report to the food and drug supervision and administration department of the people's government in the province, autonomous region or municipality directly under the Central Government where it is located, and make such advertisement public.
The administrative department for industry and commerce shall, in accordance with the provisions of relevant laws and administrative regulations on administration over advertisements, supervise and examine the advertisement of medical devices and punish illegal acts. If the food and drug supervision and administration department finds any illegal release of advertisement of medical devices, it shall propose the handling suggestions and transfer the case according to the relevant procedures to the administrative department for industry and commerce at the same level where it is located.

Article 60 The food and drug supervision and administration department under the State Council shall establish a unified supervision and administration information platform for medical devices. The food and drug supervision and administration department shall timely disclose such daily supervision and administration information as license, record-filing, random inspection and punishment of illegal acts of medical devices on the information platform, but shall not reveal the trade secrets of the party concerned.
The food and drug supervision and administration department shall set up credit archives for registrants, record-filing persons of medical devices, producing and operating enterprises and users and conduct more supervision and examination on those with bad credit records.

Article 61 The food and drug supervision and administration department and other departments shall make public their contact information and accept the consultations, complaints and reporting. When the food and drug supervision and administration department and other departments are consulted on supervision and administration of medical devices, they shall give a reply in a timely manner; if receiving a complaint and reporting, they shall check and handle the complaint and reporting and give a reply in a timely manner. The information on consultations, complaints and reporting as well as the reply, check and handling shall be recorded and kept.
Where the reporting on research, production, operation and use of medical devices is investigated to be true, the food and drug supervision and administration department and other departments shall give an award to reporters.

Article 62 When the food and drug supervision and administration department under the State Council formulates, adjusts and revises the contents specified herein and specifications related to the supervision and administration over medical devices, it shall seek for public comments, and it shall, by means of hearing and discussion meetings or otherwise, listen to the opinions of experts, producing and operating enterprises and users of medical devices, consumers and the relevant organizations.

Chapter VII Legal Liabilities

Article 63 Under any of the following circumstances, the food and drug supervision and administration department of the people's government at county level or above shall confiscate illegal gains, the illegally produced and operated medical devices and tools, equipment, raw materials and other articles used for illegal production and operation; where the value of illegally produced and operated medical devices is less than CNY10,000, a fine of not less than CNY50,000 but not more than CNY100,000 shall be imposed; where the value is not less than CNY10,000, a fine of not less than ten times but not more than 20 times the value shall be imposed; where the circumstances are serious, the application for license of medical devices proposed by the relevant persons responsible and enterprises shall not be accepted within five years:
1. the enterprise produces and operates Class II and Class III medical devices without obtaining the medical device registration certificate;
2. the enterprise engages in the production of Class II and Class III medical devices without permission; and
3. the enterprise engages in the operation of Class III medical devices without permission.
Where the circumstance of Item 1 of the preceding paragraph occurs and the circumstance is serious, the original issuing department shall revoke the medical device production license or the medical device operation license.
Any person allocating and using large-sized medical equipment without permission shall be ordered by the health and family planning department at the county level or above to crease the use, given a warning, and its illegal gains be confiscated; and if the illegal gains are less than CNY10,000, a fine of not less than CNY10,000 but not more than CNY50,000 shall be imposed; and if the illegal gains are more than CNY10,000, a fine of not less than five times but not more than ten times the illegal gains shall be imposed; where the circumstances are serious, the application for license for allocation of large-sized medical equipment filed by the relevant persons responsible and enterprises shall not be accepted within five years.

Article 64 In case the medical device registration certificate, medical device production license, medical device operation license, license for allocation of large-sized medical equipment, advertisement approval documents and other licenses have been obtained by providing false materials or through other deceptive means, the original issuing department shall revoke the license granted and impose a fine of not less than CNY50,000 but not more than CNY100,000, and the application for license of medical devices filed by the relevant persons responsible and enterprises shall not be accepted within five years.
In case the relevant medical device licenses are counterfeited, altered, traded, leased or lent, the original issuing department shall confiscate or revoke such licenses and confiscate illegal gains; in case the illegal gains are less than CNY10,000, a fine of not less than CNY10,000 but not more than CNY30,000 shall be imposed; in case the illegal gains are not less than CNY10,000, a fine of not less than three times but not more than five times the illegal gains shall be imposed; in case a violation of security administration is constituted, the public security organs shall impose a security administration punishment in accordance with the law.

Article 65 Where a record-filing fails to be made in accordance with the Regulations, the food and drug supervision and administration departments of the local people's governments at county level or above shall order to make corrections within the time limit; if corrections are not made within the time limit, the unit and names of products failing to be record-filed shall be made public and a fine of not more than CNY10, 000 shall be imposed.
Where false materials are provided in record-filing, the food and drug supervision and administration departments of the local people's governments at county level or above shall make public the unit and names of products to be record-filed; if the circumstance is serious, the person directly responsible shall not engage in the production and operation of medical devices with five years.

Article 66 Under any of the following circumstances, the food and drug supervision and administration department of the people's government at county level or above shall order to make corrections, confiscate the illegally produced, operated or used medical devices; where the value of illegally produced, operated or used medical devices is less than CNY10,000, a fine of not less than CNY20,000 but not more than CNY50,000 shall be imposed; where the value is not less than CNY10,000, a fine of not less than five times but not more than ten times the value shall be imposed; where the circumstances are serious, the food and drug supervision and administration department of the people's government at county level or above shall order to stop the production and operation and the original issuing department shall revoke the medical device registration certificate, medical device production license and medical device operation license:
1. the enterprise produces, operates or uses medical devices that do not comply with the compulsory standards or the registered or record-filed technical requirements for products;
2. the producing enterprise of medical devices fails to organize the production according to the registered or record-filed technical requirements for products; or to establish quality management system and keep effective operation in accordance with the provisions hereof;
3. the enterprise operates and uses the expired, invalid and obsolete medical devices without eligible supporting materials or uses those failing to be registered in accordance with the law;
4. the enterprise refuses to recall medical devices or stop the operation of medical devices after the food and drug supervision and administration department order it to recall medical devices or stop the operation of medical devices in accordance with the provisions hereof; and
5. the enterprise entrusts other enterprises without the conditions specified herein to produce medical devices or fails to manage the production by the entrusted.
If the operating enterprises or users of medical devices have fulfilled their incoming inspection and other obligations as stipulated by the Regulations, and have sufficient evidence to prove that they do not know that the medical devices that they operate or use are those stipulated in Items 1 and 3 of the preceding paragraph, and are able to truthfully state the sources of their purchase, they may be exempt from punishments, while the medical devices they operate and use that fail to meet the legal requirements shall be confiscated in accordance with law.

Article 67 Under any of the following circumstances, the food and drug supervision and administration department of the people's government at county level or above shall order to make corrections and impose a fine of not less than CNY10,000 but not more than CNY30,000; where the circumstances are serious, the food and drug supervision and administration department of the people's government at county level or above shall order to stop the production and operation and the original issuing department shall revoke the medical device production license and medical device operation license:
1. production conditions of the producing enterprise of medical devices have been changed and thus no longer meet the requirements of quality management system for medical devices but the producing enterprise fails to rectify the conditions and to stop the production and reporting in accordance with the Regulations;
2. production and operation instructions and labels do not comply with those for medical devices specified herein;
3. the enterprise fails to transport and store the medical devices according to the requirements of instructions and labels thereof; and
4. the enterprise transfers the expired, invalid, obsolete and unqualified medical devices in use.

Article 68 Under any of the following circumstances, the food and drug supervision and administration department and health and family planning department of the people's government at county level or above shall, according to their respective duties, order to make corrections and give a warning; where the enterprise refuses to make corrections, then a fine of not less than CNY5,000 but not more than CNY20,000 shall be imposed; where the circumstances are serious, the food and drug supervision and administration department and health and family planning department of the people's government at county level or above shall order to stop the production and operation and the original issuing department shall revoke the medical device production license and medical device operation license:
1. the producing enterprise of medical devices fails to submit the quality management system self-inspection report;
2. the operating enterprise and user of medical devices fail to establish and implement the entry inspection record system for medical devices in accordance with the provisions hereof;
3. the operating enterprise engaging in wholesale business of Class II and Class III medical devices and retail business of Class III medical devices fails to establish and implement the sales record system in accordance with the provisions hereof;
4. the user of medical devices fails to handle the reused medical devices in accordance with the provisions on sterilization and administration;
5. the user of medical devices reuses the disposable medical devices or fails to destroy the disposable medical devices that have been used in accordance with the provisions;
6. for medical devices that need regular check, inspection, calibration and maintenance, the user of medical devices fails to do so according to the requirements of the product instructions and to make records, timely analysis and evaluation so as to make sure the medical devices are in a good condition;
7. the user of medical devices fails to carefully keep the source materials of Class III medical devices purchased or fails to record the information on large medical devices and implantable and interventional medical devices in the medical history and other relevant records;
8. the user of medical devices that has found medical devices with potential safety hazards does not stop the use or ask for maintenance or continues to use the medical devices that are repaired but are not up to the safety use standards;
9. Where the user of medical devices uses large-sized medical equipment in violation of regulations, and fails to guarantee the medical quality and safety", and the original Item 9 is changed to be Item 10; and
10. the producing and operating enterprise and user of medical devices fail to monitor the adverse events of medical devices in accordance with the provisions hereof and to report the adverse events as required, or are not cooperative in investigation on the adverse events by the monitoring technical institutions of adverse events of medical devices and the food and drug supervision and administration department.

Article 69 Where an institution organizes clinical trials for medical devices in violation of the Regulations, the food and drug supervision and administration department of the people's government at the county level or above shall order it to make corrections or to immediately stop the clinical trials and may impose a fine of not more than CNY50,000; where a serious consequence is caused, such punishments as demotion, dismissal or discharge shall be imposed upon the directly responsible person and other persons directly liable; and this institution shall not carry out relevant professional clinical trials for medical devices within five years.
Where a clinical trial institution for medical devices issues a false report, a fine of not less than CNY50,000 but not more than CNY100,000 shall be imposed by the food and drug supervision and administration department of the people's government above the county level; illegal gains, if any, shall be confiscated; such punishments as dismissal or discharge shall be imposed upon the directly responsible person and other persons directly liable; this institution shall not carry out relevant professional clinical trials for medical devices within ten years.

Article 70 Where the inspection institutions of medical devices issue false inspection reports, the competent department that grants such qualifications shall cancel the inspection qualifications and shall not accept the application for qualification identification within ten years; a fine of not less than CNY50,000 but not more than CNY100,000 shall be imposed; illegal gains, if any, shall be confiscated; such punishments as dismissal or discharge shall be imposed upon the directly responsible person and other persons directly responsible; where the punishment of discharge is imposed, the inspection institutions shall not engage in the inspection of medical devices within ten years as of the date of such punishment.

Article 71 In violation of the provisions hereof, where the enterprise publishes the advertisement of medical devices whose approval documents are not obtained, publishes the advertisement of medical devices without proving the authenticity of the approval documents in advance or publishes the advertisement whose contents published are inconsistent with the approval documents, the administrative department for industry and commerce shall impose punishments in accordance with the provisions of the laws and administrative regulations on advertisement management.
Where the enterprise falsifies the contents of approved advertisement of medical devices, the original issuing department shall cancel the approval documents of such medical devices and shall not accept its applications for approval of advertisements within two years.
Where the enterprise publishes false advertisement of medical devices, the food and drug supervision and administration department of the people's government at county level or above shall decide to stop the sales of such medical devices and make it public; where the enterprise still sells such medical devices, the food and drug supervision and administration department of the people's government at county level or above shall confiscate the illegally sold medical devices and impose a fine of not less than CNY20,000 but not more than CNY50,000.

Article 72 Where technical evaluation institutions of medical devices and monitoring technical institutions of adverse events of medical devices, who fail to perform their duties in accordance with the provisions hereof, make major mistakes in the process of evaluation and monitoring, the food and drug supervision and administration department of the people's government at county level or above shall order them to make corrections, circulate a note of criticism and give a warning; where serious consequences have been caused, such punishments as degradation, dismissal or discharge shall be imposed on the directly responsible person and other persons directly responsible in accordance with the law.

Article 73 The food and drug supervision and administration departments, the health and family planning departments and the staff thereof shall, in strict accordance with the types and range of punishments specified herein and based on the nature of violations and specific circumstances, exercise the power of administrative penalty. Specific measures shall be formulated by the food and drug supervision and administration department and the health and family planning department under the State Council according to their respective duties.

Article 74 In violation of the provisions hereof, the food and drug supervision and administration department of the people's government at county level or above or other relevant departments do not perform their duties of supervision and administration over medical devices or misuse their authority, neglect their duties or practice graft, the supervision organ or the department in charge of appointment and removal shall give a warning, record a demerit or record a serious demerit on the directly responsible person and other persons directly responsible; where serious consequences have been caused, such punishments as degradation, dismissal or discharge shall be imposed in accordance with the law.

Article 75 In violation of the provisions hereof, where a crime has been constituted, criminal liability shall be pursued in accordance with the law; where any damage to person or property or other damages have been caused, the
compensation liabilities shall be assumed in accordance with the law.

Chapter VIII Supplementary Provisions

Article 76 Definitions of the following terms herein:
Medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrators, materials as well as other similar or relevant articles, including necessary computer software; the utility of medical devices is mainly achieved by physical or other means instead of by means of pharmacology, immunology or metabolism or by such means but only acting as auxiliary functions, the purposes of which are as follows:
1. diagnose, prevention, monitoring, treatment or relief on diseases;
2. diagnose, monitoring, treatment, relief or functional compensation on injury;
3. inspection on, substitution for, adjustment to or support of physical structures or physical process;
4. support or maintenance of life;
5. control of pregnancy; and
6. inspection on sample of human body to provide information for medical treatment or diagnosis.
The user of medical devices refers to the institutions that use medical devices to provide medical treatment and other technical services, including the medical institutions that have obtained the Practicing License of Medical Institutions, family planning technical service institutions that have obtained the Practicing License of Family Planning Technical Service Institutions and blood stations, blood plasma stations and assistive product adaption institutions that do not need to have Practicing License of Medical Institutions.
Large-sized medical equipment refer to the large-sized medical devices with complicated using technique, large-scale capital investment, and high operation costs, which would have a great influence on medical fees and which are subject to the catalogue management.

Article 77 Fees for registration of medical devices may be charged. Specific charging items and standards shall be worked out respectively by the competent financial and pricing departments under the State Council in accordance with relevant provisions of the state.

Article 78 Administrative measures for non-profit contraceptive medical devices and administrative measures of medical sanitation institutions for medical devices researched to response to public health emergencies shall be prepared by the food and drug supervision and administration department under the State Council in concert with the competent health and family planning department of the State Council.
Administrative measures for traditional Chinese medical devices shall be prepared by the food and drug supervision and administration department under the State Council in concert with the traditional Chinese medicine administration department under the State Council in accordance with the relevant provisions hereof; the scope of assistive medical devices and administrative measures thereof shall be prepared by the food and drug supervision and administration department under the State Council in concert with the civil administration department under the State Council in accordance with the provisions hereof.

Article 79 The supervision and administration over use of military medical devices shall be organized and implemented by the competent military health department in accordance with the Regulations and the relevant military provisions.

Article 80 The Regulations shall come into force as of June 1, 2014.