The regulations on the supervision and administration of medical devices

The regulations on the supervision and administration of medical devices

Chapter 1

 

General provisions

 

Article 1 these regulations are formulated in order to strengthen the supervision and management of medical devices, ensure the safety and effectiveness of medical devices, and ensure human health and safety of life.

 

Article 2 units or individuals engaged in the development, production, operation, use and supervision of medical devices in the territory of the People's Republic of China shall abide by these regulations.

 

Article 3 medical devices referred to in these regulations refer to instruments, equipment, instruments, materials or other objects which are used in the human body alone or in combination, including the necessary software;It is not obtained by means of pharmacology, immunology or metabolism, but may have the aid of these methods.Its purpose is to achieve the following purposes:

(1) prevention, diagnosis, treatment, monitoring and mitigation of the disease;

(2) diagnosis, treatment, monitoring, mitigation and compensation of injury or disability;

(3) study, substitution and adjustment of anatomy or physiological processes;

(4) pregnancy control.Article 4 the pharmaceutical supervisory and administrative department under the state council shall be responsible for the supervision and administration of medical devices throughout the country.The pharmaceutical supervisory and administrative departments of local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices in their respective administrative areas.The pharmaceutical supervisory and administrative departments under the state council shall cooperate with the economic comprehensive management department of the state council to implement the national medical device industrial policy.

Article 5 the state practices classified administration of medical devices.The first category refers to medical devices that are routinely managed to ensure their safety and effectiveness.The second type refers to medical devices that should be controlled for their safety and effectiveness.The third category refers to the implantation of the human body;To support and sustain life;Medical devices that are potentially dangerous to the human body and have strict control over its safety and effectiveness.The classified catalogue of medical devices shall be formulated, adjusted and promulgated by the department of health administration under the state council according to the classification rules of medical devices.

Article 6 medical devices that are produced and used to provide specific quantitative values shall conform to the provisions of the measurement law.The specific product catalogue shall be formulated and promulgated by the pharmaceutical supervisory and administrative department under the state council jointly with the metrological administrative department of the state council.

 

Chapter ii administration of medical devices

 

Article 7 the state encourages the development of new products for medical devices.New products of medical devices refer to new varieties that have not yet appeared in domestic market or have not been approved by domestic market.The clinical trial of the new products of category ii and iii medical devices shall be carried out according to the provisions of the pharmaceutical supervisory and administrative department under the state council.To complete the clinical trial and to organize the new products of medical devices that are reviewed by experts from the pharmaceutical supervisory and administrative department under the state council, approved by the pharmaceutical supervisory and administrative department under the state council and issued to the new product certificate.

 

Article 8 the state shall implement a product registration system for medical devices.The first type of medical devices shall be examined and approved by the pharmaceutical supervisory and administrative departments of the municipal people's governments at the district level and issued the certificate of production registration.The production of the second type of medical devices shall be examined and approved by the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government, and shall be issued to the product registration certificate.The production of a third type of medical equipment shall be examined and approved by the pharmaceutical supervisory and administrative department under the state council and issued to the product registration certificate.The production of the second and third types of medical devices shall be verified through clinical practice.

 

Article 9 the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government shall be responsible for the examination and approval of the clinical trials or clinical trials of the second category of medical devices in the administrative region.The drug regulatory authority under the state council shall be responsible for the approval of clinical trials or clinical verification of the third type of medical devices.Clinical trial or clinical verification shall be conducted by the medical establishment designated by the drug supervision and administration department of the people's government at or above the provincial level.The clinical trial or clinical verification of medical institutions shall conform to the provisions of the pharmaceutical supervisory and administrative department under the state council.The qualification of a medical institution undergoing clinical trial or clinical verification shall be determined by the pharmaceutical supervisory and administrative department under the state council and the department of health administration under the state council.Article 10 medical institutions may, in accordance with the clinical requirements of this unit, develop medical devices and use them in their units under the guidance of practicing physicians.Medical devices developed by medical institutions shall be submitted to the pharmaceutical supervisory and administrative departments of the people's governments at or above the provincial level for examination and approval;The third type of medical equipment developed by medical institutions shall be submitted to the pharmaceutical supervisory and administrative department under the state council for examination and approval.

 

Article 11 for the first time to import medical devices, the import entity shall provide the medical equipment instructions, quality standards, inspection methods and other relevant materials and samples as well as the exporting countries (regions) approval documents, production and sales of the pharmaceutical supervisory and administrative department under the state council for examination and approval of registration, obtaining import registration certificate book, may apply to the customs for import formalities.

 

Article 12 the application for registration of medical devices shall be submitted to technical indicators, test reports and other relevant materials in accordance with the provisions of the drug regulatory authority under the state council.The pharmaceutical supervisory and administrative departments of the municipal people's governments at the city level shall, within 30 working days from the date of accepting the application, make a decision whether to give the registration;If the registration is not registered, the reasons shall be given in writing.The pharmaceutical supervisory and administrative departments of the people's governments of the provinces, autonomous regions and municipalities directly under the central government shall, within 60 working days from the date of accepting the application, make a decision on whether to give the registration;If the registration is not registered, the reasons shall be given in writing.The pharmaceutical supervisory and administrative department under the state council shall, within 90 working days from the date of accepting the application, make a decision whether to give the registration;If the registration is not registered, the reasons shall be given in writing.

Article 13 in the event of changes in the contents listed in the registration certificate of medical device products, the certified entity shall apply for the alteration procedure or re-register within 30 days from the date of the change.

 

Article 14 the registration certificate of medical device products shall be valid for four years.The card holder shall apply for re-registration within 6 months prior to the expiration of the validity period of the product registration certificate.If continuous production of production for more than 2 years, the product production registration certificate shall be invalid on its own.

 

Article 15 the production of medical devices shall conform to the national standards of medical devices;Where there is no national standard, it shall meet the standards of medical device industry.The national standards for medical devices shall be formulated by the department of standardization administration under the state council and the pharmaceutical supervisory and administrative department under the state council.The standards for medical device industry shall be formulated by the pharmaceutical supervisory and administrative department under the state council.

 

Article 16 the instructions, labelling and packaging of medical devices shall conform to the relevant national standards or regulations.

 

Article 17 medical devices and their foreign packaging shall, in accordance with the provisions of the pharmaceutical supervisory and administrative department of the state council, indicate the product registration certificate number.

 

Article 18 the state shall implement reevaluation and elimination of medical devices.The specific measures shall be formulated by the department of pharmaceutical supervision and administration under the state council.

 

Chapter iii administration of production, operation and use of medical devices

 

Article 19 a manufacturer of medical devices shall meet the following conditions:

(1) specialized technical personnel who are suitable for the medical devices produced by them;

(2) the production site and environment suitable for the medical devices produced;

(3) production equipment that is suitable for the medical equipment produced;

(4) institutions or personnel and inspection equipment that have quality inspection of the medical device products they produce.

 

Article 20 the establishment of the first type of medical device producing enterprises shall be filed with the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government.To start the second and third class medical device manufacturing enterprise, shall be subject to the people's governments of provinces, autonomous regions and municipalities directly under the central government pharmaceutical supervisory and administrative department for examination and approval, and sent to the medical device manufacturing enterprise license.The administrative department for industry and commerce shall not issue a business license without the medical device production enterprise license.The term "medical device production enterprise license" is valid for 5 years, and the expiration date shall be re-examined and issued.Specific measures shall be formulated by the pharmaceutical supervisory and administrative department under the state council.

 

Article 21 a medical device manufacturer may produce medical devices after obtaining a certificate of production registration of medical device.

 

Article 22 the state shall implement a compulsory safety certification system for some third medical devices.The specific product catalogue shall be formulated by the pharmaceutical supervisory and administrative department under the state council and the quality and technical supervision department under the state council.

 

Article 23 a medical device operating enterprise shall meet the following conditions:

(1) the business site and environment that is suitable for the medical instruments operated by it;

(2) quality inspection personnel who have the appropriate medical equipment to operate;

(3) technical training, maintenance and other after-sales service capacity of the medical device products that are in line with the operation.

 

Article 24 the establishment of the first type of medical device operating enterprises shall be filed with the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government.To start the second, third class medical equipment management enterprise, shall be subject to the people's governments of provinces, autonomous regions and municipalities directly under the central government pharmaceutical supervisory and administrative department for examination and approval, and the medical equipment business license is issued.The administrative department for industry and commerce shall not issue a business license without the medical instrument operating enterprise license.The term of validity of the term of validity of the medical device operating enterprise license shall be renewed.Specific measures shall be formulated by the pharmaceutical supervisory and administrative department under the state council.

Article 25 the people's governments of provinces, autonomous regions and municipalities directly under the central government pharmaceutical supervisory and administrative departments shall accept it since the medical device manufacturing enterprise, business license, within 30 working days from the date of application, make a decision on whether the issuance of;If the license is not issued, the reasons shall be given in writing.

 

Article 26 the medical device operation enterprises and medical organizations shall obtain the medical device manufacturing enterprise license from the production enterprise or obtain medical equipment business license of enterprise purchase qualified medical devices, and verify the product qualified certificate.Medical device operating enterprises shall not operate unregistered, unqualified certificates, expired, expired or obsolete medical devices.Medical institutions shall not use unregistered, unqualified certificates, expired, expired or obsolete medical devices.

 

Article 27 medical institutions shall not repeat the use of medical devices that are disposable;If used, they shall be destroyed in accordance with the relevant provisions of the state and shall be recorded.

 

Article 28 the state shall establish a system for reporting the quality of medical devices and the system of notice for the quality of medical devices.Specific measures shall be formulated by the pharmaceutical supervisory and administrative department under the state council jointly with the department of health administration under the state council and the family planning administrative department.Chapter iv supervision of medical devices

 

Article 29 the pharmaceutical supervisory and administrative departments of the people's governments at or above the county level shall establish medical device supervisors.The medical device supervisors shall supervise and inspect the production enterprises, operating enterprises and medical institutions of medical devices in the administrative region;If necessary, the samples and the relevant information may be extracted according to the provisions of the pharmaceutical supervisory and administrative department under the state council, and the relevant units and personnel shall not refuse or conceal them.The supervisor shall have the obligation to keep confidential the samples and materials obtained.

 

Article 30 the state shall implement the system of qualification recognition for medical device testing institutions.The pharmaceutical supervisory and administrative departments under the state council shall, together with the inspection agencies recognized by the department of quality and technical supervision of the state council, be allowed to carry out testing of medical devices.Medical device testing institutions and their staff of technical data of tested units with a confidentiality obligation, shall not engage in or participate in related to detection of medical equipment development, production, management and technical consulting and other activities.

 

Article 31 for medical devices has caused quality accident or may cause medical equipment products quality accidents and related data, the pharmaceutical supervisory and administrative department under the local people's governments at or above the county level shall seal up, distrain.

 

Article 32 the pharmaceutical supervisory and administrative departments of the people's governments at or above the provincial level shall revoke their product registration certificates for medical devices that are not guaranteed to be safe and effective.Medical equipment product registration certificate has been revoked shall not be production, sales and use, has the production or import, by the pharmaceutical supervisory and administrative department under the local people's government at or above the county level shall be responsible for the supervision and handling.

 

Article 33 the pharmaceutical supervisory and administrative departments of the local people's governments at or above the municipal level of the district shall be ordered to make corrections within a time limit by the pharmaceutical supervisory and administrative department under the state council for violating the registration of products in violation of these regulations.If the person fails to make corrections within the time limit, he may revoke the certificate of registration of medical device products and make an announcement.

Article 34 advertisements for medical devices shall be examined and approved by the pharmaceutical supervisory and administrative departments of the people's governments at or above the provincial level;Without approval, it shall not be published, broadcast, distributed or posted.The contents of the advertisements for medical devices shall be subject to the use instructions approved by the pharmaceutical supervisory and administrative department of the state council or the drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the central government.

 

Chapter v punishment

 

The machinery, or from the medical device manufacturing enterprise license or medical equipment business license of enterprise purchase medical equipment, produced by the county line, and confiscate the illegal products and illegal