Notice of the State Food and Drug Administration on Expanding the Pilot Work of the Medical Device Registrant System(National Medicine Supervision Machinery Note [2019] No. 33)

Drug supervision and management in Beijing, Tianjin, Hebei, Liaoning, Heilongjiang, Shanghai, Jiangsu, Zhejiang, Anhui, Fujian, Shandong, Henan, Hubei, Hunan, Guangdong, Guangxi, Hainan, Chongqing, Sichuan, Yunnan, Shaanxi (autonomous region, municipality) Bureau:

In order to thoroughly implement the 'Opinions on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Drug Medical Devices' issued by the General Office of the CPC Central Committee and the General Office of the State Council (Dongzi [2017] No. 42), accelerate the innovation and development of the medical device industry. Based on the implementation of the medical device registrant system and the pilot work of the medical device registrant system in the Shanghai, Guangdong and Tianjin Free Trade Zones, the State Drug Administration (hereinafter referred to as the National Bureau) decided to further expand the medical device registrant system. For the pilot work, the relevant matters are hereby notified as follows:

First, the scope of the pilot

Beijing, Tianjin, Hebei, Liaoning, Heilongjiang, Shanghai, Jiangsu, Zhejiang, Anhui, Fujian, Shandong, Henan, Hubei, Hunan, Guangdong, Guangxi, Hainan, Chongqing, Sichuan, Yunnan, Shaanxi (autonomous regions, municipalities).

Second, the pilot content and objectives

(1) Exploring the establishment of a medical device entrusted production management system, optimizing resource allocation, and implementing the main responsibility. A medical device registration applicant (hereinafter referred to as the “applicant”) who applies for and obtains a medical device registration certificate becomes a medical device registrant (hereinafter referred to as “the registrant”). The applicant can entrust a company with the corresponding production capacity to produce samples, and the registrant can entrust the certified products to one or more enterprises with production capacity to produce the products. Encourage group companies to further integrate and optimize resource allocation through the pilot system of registrants, and implement the main responsibilities of medical device registrants.

(2) Exploring and establishing a sound quality management system for registrant medical devices, clarifying the legal relationship between medical device registrants and trustees, and building a registrant's life cycle quality management on the basis of clear responsibilities and controllable risks. Institutions and systems.

(3) Exploring innovative medical device supervision methods, effectively implementing the requirements of “regulatory work must be kept up”, perfecting the post-event supervision system, clarifying cross-regional regulatory responsibilities, forming a comprehensive cross-regional coordinated supervision mechanism, enhancing regulatory synergy, and enhancing Regulatory effectiveness.

(4) Exploring and releasing the dividend of the medical device registrant system, encouraging medical device innovation, and promoting the high-quality development of the medical device industry.

(5) Accumulating the pilot experience of the medical device registrant system, providing important support for the comprehensive implementation of the medical device registrant management system.

The products that are prohibited by the former State Food and Drug Administration from prohibiting the production of medical device catalogues are not included in the pilot.

Third, the registrant's conditions and obligations

(1) Condition of the registrant

1. The residence or production address is located in the enterprises, scientific research institutions in the provinces, autonomous regions and municipalities directly under the Central Government participating in the pilot.

2. Full-time technical and management personnel related to regulatory affairs, quality management, post-marketing affairs, etc., with relevant knowledge and experience in medical device regulatory regulations and standards.

3. Establish a quality management system that is compatible with the product and maintain effective operation. There are personnel who independently evaluate, review and supervise the quality management system.

4. Ability to assume responsibility for quality and safety of medical devices.

(2) The responsibilities of the registrant

1. To bear the corresponding legal responsibilities in the aspects of medical device design and development, clinical trials, manufacturing, sales and distribution, after-sales service, product recall, and adverse event reporting.

2. Sign the entrustment contract and quality agreement with the entrusted production enterprise, clarify the responsibility for technical requirements, quality assurance, responsibility division and release requirements in the entrusted production, and clarify the production release requirements and the way the products are released.

3. Strengthen the supervision and management of the entrusted production enterprises, evaluate the quality management capabilities of the entrusted production enterprises, and conduct regular evaluation and audit of the quality management system of the entrusted production enterprises.

4. Strengthen the monitoring of adverse events, establish a corresponding traceability management system for medical devices according to the risk level, and ensure that medical device products can meet the requirements of full traceability.

5. You can sell medical equipment by yourself, or you can entrust a medical equipment business with relevant qualifications to sell. The registrant who sells itself shall have the prescribed medical device operating capacity and conditions; if the commission is sold, an entrustment contract shall be signed to clarify the rights and obligations of the parties.

6. Through the information technology, the whole process of R&D, production, sales and monitoring of adverse events will be traced and monitored.

7. Ensure that the submitted research data and clinical trial data are authentic, systematic, and traceable.

4. Conditions and obligations of the entrusted production enterprise

(1) Conditions for entrusted production enterprises

1. The residence or production address is located in the provinces, autonomous regions and municipalities directly involved in the pilot.

2. Have a quality management system and production capacity that is compatible with the medical equipment that is entrusted to produce.

(2) Obligation of the entrusted production enterprise

1. To undertake the obligations of the Regulations on the Supervision and Administration of Medical Devices, and other relevant laws and regulations as well as the entrustment contracts and quality agreements, and assume corresponding legal responsibilities.

2. Organize production according to the relevant regulations of medical equipment and the requirements stipulated in the contract and quality agreement, and bear the corresponding quality responsibility for the registrant.

3. If a major quality accident occurs in a medical device after listing, it shall be reported to the provincial drug regulatory authority at the local level.

4. When the entrusted production is terminated, the entrusted production enterprise shall apply to the local provincial drug regulatory authority to reduce the information of the entrusted products published in the production product registration form attached to the medical device production license.

5. The entrusted production enterprise shall not be transferred again.

V. Procedures

(1) Application for registration. If the registered applicant submits the medical device registration application, it shall submit the registration application materials to the corresponding drug regulatory authority. If the examination meets the requirements, the medical device registration certificate shall be issued. If the production address published in the medical device registration certificate is the registered production address, the remarks column shall be marked. Trustee name.

(2) Processing license processing. If the entrusted production enterprise does not have the corresponding production qualification, it may submit the registrant's medical device registration certificate to apply for the production license or apply for the production license change, and submit the cross-regional pilot to the provincial drug regulatory department where the entrusted production enterprise is located.

(3) Change of the registration of the production address. Where the registrant intends to change the production address of the registration certificate by means of entrusted production, the provincial drug regulatory department at the place where the entrusted production enterprise is located shall carry out on-site inspection with the provincial drug regulatory authority at the place where the registrant is located, and shall be changed by the provincial drug regulatory authority at the place where the entrusted production enterprise is located. Medical Device Production License. After the registrant submits the “Medical Device Production License” and the entrustment agreement after the change of the entrusted production enterprise, it shall change the registration items to the corresponding drug regulatory department.

(4) Being entrusted with the record. The entrusted production enterprise shall file with the local provincial drug regulatory authority, and shall submit the entrustment contract, quality agreement and other materials when filing.

Six, work requirements

(1) Strengthening organizational coordination. The National Bureau is responsible for organizing the pilot project of the national medical device registrant system. Each pilot provincial drug regulatory department shall set up a pilot working group led by the head of the branch administration to study and formulate the implementation plan and relevant management system for the pilot work, improve the working mechanism, strengthen the input of strength, and strengthen the team of professional and professional inspectors. Solidly promote the pilot work. The pilot drug regulatory departments at the provincial level combined with the local medical device industry and supervision, and formulated a pilot work plan as soon as possible on the basis of full investigation and demonstration, and reported it to the national bureau in time.

(2) Strengthen supervision and management. The drug regulatory authorities at all levels shall strengthen the supervision and management of the registrant's performance of guaranteeing the quality of medical devices, listing sales and services, monitoring and evaluation of adverse events of medical devices, and recall of medical devices. In the case of cross-regional pilots, the provincial drug regulatory authorities shall, on a coordinated basis, determine the division of responsibilities between the various parties in the cross-regional supervision, implement the main body of daily regulatory responsibility, and ensure that there is no gap in the supervision of the entire chain of medical devices throughout the life cycle. It is necessary to establish a mechanism for collaborative management, information sharing and mutual recognition of results. The drug regulatory authorities may conduct extended inspections for other relevant units that provide products or services for the development, production, operation, and use of medical devices.

(3) Encourage social participation. All pilot provincial drug regulatory authorities should give full play to the role of industry associations, fully listen to corporate opinions and suggestions through industry associations; organize legal experts to study and draft model commission agreements; and encourage social forces to actively participate in the construction of corporate quality responsibility assurance capabilities in appropriate forms.

(4) Promote information sharing. The pilot drug administration departments at all levels shall, according to regulations, proactively disclose and submit the progress and latest developments of the pilot work to the national bureau in a timely manner.

(5) Summing up the experience in a timely manner. All pilot provincial drug regulatory authorities should pay attention to the follow-up pilot situation in a timely manner, sum up in a timely manner, analyze the achievements and problems, and form a solution proposal, and report it to the national bureau in time.

State Food and Drug Administration

August 1, 2019