CFDA interprets "Measures for the Management of Medical Device Standards"


CCTV news: According to the website of the China Food and Drug Administration, recently, the State Food and Drug Administration organized the revision of the original "Medical Device Standard Management Measures (Trial)" to form the "Medical Device Standard Management Measures" (hereinafter referred to as the "Measures"). "), on February 21, 2017, the "Measures" were deliberated and adopted at the executive meeting of the State Food and Drug Administration, and came into force on July 1, 2017. Regarding the overall revision, the definition of medical device standards and other issues, the CFDA has interpreted for everyone, the details are as follows:

I. Background of the revision of the Measures

In 2002, the former State Drug Administration issued and implemented the "Administrative Measures for Medical Device Standards (for Trial Implementation)" (Order No. 31 of the former Bureau), which played an important role in guiding the standardization management of medical devices in my country, standardizing the formulation and revision of standards, and promoting the implementation of standards. positive impetus.

With the continuous development of medical device standardization, the former State Drug Administration established a full-time organization for the management of medical device standards in 2010, further strengthening the organization and management of medical device standards, and the medical device standard management system has changed.

In June 2014, the State Council promulgated the "Regulations on the Supervision and Administration of Medical Devices" (Order No. 650 of the State Council) (hereinafter referred to as the "Regulations"), which cancelled the registered product standards, clarified the legal status of product technical requirements, and changed the original national standards for medical devices. The three-level standard system consisting of , industry standards and registered product standards, the medical device standard system has changed accordingly.

In 2015, the State Council issued the "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices" (Guo Fa [2015] No. 44), which put forward clear requirements for the standard work of medical devices.

At the same time, in March 2015, the State Council issued the "Reform Plan for Deepening Standardization Work". In 2016, the Legislative Affairs Office of the State Council publicly solicited opinions on the Standardization Law of the People's Republic of China (Revised Draft for Comment), China's standardization system and management system are facing major adjustments, a new national standard system is gradually established, and a new standardization pattern is taking shape.

Further implement the State Council's "Deepening Standardization Work Reform Plan" and "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices" (Guo Fa [2015] No. 44), meet the new needs of medical device supervision and industrial development, and adapt to medical device standards To meet the new requirements of development, the General Administration organized the revision of the "Administrative Measures for Medical Device Standards".

2. About the overall revision

The "Measures" have been increased from 24 to 36. According to the new version of the "Regulations" and the "Medical Device Registration Management Measures", the entire chapter "Formulation and Review of Registered Product Standards" in the original "Measures" and related "Medical Device Registration" have been deleted. The content of "Product Standards" has added the relevant content of product technical requirements, and clarified the relationship between product technical requirements and mandatory standards and recommended standards. The relevant content of the chapter "Implementation and Supervision of Standards" has been improved, the responsibilities of standard management and the working procedures of standard formulation and revision have been further refined, and the content of standard disclosure and standard tracking evaluation has been emphasized.

3. Definition of medical device standards

The "Measures" clarifies the definition of medical device standards, which refers to the unified standards that the State Food and Drug Administration organizes and revises according to their responsibilities, publishes them in accordance with the law and procedures, and follows in the development, production, operation, use, supervision and management of medical devices and other activities. technical requirements.

4. About the standard classification of medical devices

The "Measures" further clarified the relationship between national standards, industry standards, and mandatory and recommended standards for medical devices. Mandatory standards are technical requirements related to personal health and life safety. Mandatory standards for medical devices include mandatory national standards and mandatory industry standards; recommended standards are to meet basic general requirements, match mandatory standards, and lead the medical device industry. The technical requirements required for the role, etc. Recommended standards for medical devices include recommended national standards and recommended industry standards for medical devices.

5. Responsibilities of Standard Management

The "Measures" specify the State Food and Drug Administration, the Standard Management Center of the State Food and Drug Administration (hereinafter referred to as the Medical Device Standard Management Center), the Medical Device Standardization Technical Committee, the technical focal point for medical device standardization, and the local food and drug regulatory authorities. , the standardization responsibilities and work content undertaken by relevant units and other relevant parties.

Article 10 clarifies the responsibilities of the State Food and Drug Administration in the management of standards, and is responsible for organizing the implementation of relevant laws and regulations on the management of medical device standards, formulating the working system for the management of medical device standards; Annual work plan; organize the formulation and revision of medical device standards in accordance with the law, publish medical device industry standards, and guide and supervise the management of medical device standards in accordance with the law.

Article 11 adds the relevant responsibilities of the medical device standard management center, and clarifies that it organizes the drafting of the medical device standard planning draft, organizes the research of the standard system; undertakes the management of standard formulation and revision, the management of the standard committee, and the coordination of the implementation of the standard according to the law.

Article 12 clarifies the legal procedures for the establishment of the medical device standardization technical committee. According to the "Administrative Regulations of the National Professional Standardization Technical Committee", it is clarified that the medical device standardization technical committee is "the State Food and Drug Administration according to the needs of the medical device standardization work, through the Approval of the legally established technical committee for medical device standardization." At the same time, the responsibilities that it should perform are clarified.

Article 13 increases the responsibilities of the medical device technical focal point. The medical device field is high-tech intensive, and there are professional technical fields that cannot be covered by the existing medical device standardization technical committee. According to regulatory needs, the technical focal point for medical device standardization can be determined according to the procedures. It also stipulates that the focal point can refer to the relevant responsibilities to carry out work, which provides a basis for the standard work that is urgently needed for supervision in professional fields that have professional technical capabilities and conditions but have not yet established technical committees.

Article 14 adds the responsibilities of local food and drug supervision and administration departments. Focus on its duties of supervising the implementation of medical device standards in accordance with the law and collecting feedback.

Article 15 increases the responsibilities of relevant units, and clarifies that medical device research and development institutions, production and operation enterprises and user units shall implement the mandatory standards for medical devices. At the same time, enterprises are encouraged to actively develop and adopt recommended standards, actively participate in the formulation and revision of standards, actively undertake the drafting of recommended standards for medical devices, and give full play to the role of enterprises.

6. About standard formulation and revision

The "Measures" stipulate the working procedures for the formulation and revision of medical device standards. It is clarified that the urgently needed standards for medical device supervision can be carried out in accordance with the fast-track procedures stipulated by the State Food and Drug Administration.

At the same time, each link of standard formulation and revision, including project establishment, drafting, soliciting opinions, technical review, approval and release, review and abolition, is stipulated as a separate clause, and the key content of each link is required to be more instructive. and operability.

Regarding standard project approval, the "Measures" have added procedures such as solicitation of project approval proposals, review of project approval applications, and publicity and approval of standard plan projects. Article 17 stipulates that according to the standard plan, the proposal for the establishment and revision of medical device standards should be publicly solicited from the public; Article 18 clearly requires that the approved standard plan projects should be publicized to the public, which further improves the participation and transparency of the society.

Regarding the drafting of standards, Article 19 stipulates that any medical device production and operation enterprises, user units, regulatory authorities, testing institutions, relevant educational and scientific research institutions, social groups, etc. For an application for drafting a medical device standard, the Medical Device Standardization Technical Committee selects the drafting unit in accordance with the principles of openness, fairness and merit based on the technical content of the standard.

Regarding the standard solicitation, Article 20 clarifies that the medical device standard solicitation draft should be openly solicited from the public on the website of the Medical Device Standard Management Center. The time limit for soliciting opinions is generally two months. The work of soliciting opinions shall be organized and carried out by the Medical Device Standards Management Center.

Regarding the disclosure of standards, Article 22 stipulates that the national standards and industry standards of medical devices shall be disclosed in accordance with the relevant regulations of the National Standardization Administration for the public to consult, which increases the intensity of standard disclosure and improves the accessibility of standards. At the same time, Article 30 increases the requirements for the information management of medical device standards, and stipulates that information such as standard project establishment, release, and implementation should be disclosed to the public in a timely manner, which improves the transparency of standard management.

Regarding the standard review, according to the relevant provisions of the "Regulations on the Implementation of the Standardization Law", Article 24 clarifies that the Medical Device Standardization Technical Committee shall carry out the review of the published medical device standards, and it shall be effective in accordance with scientific and technological progress, industrial development and regulatory needs. The applicability, applicability and advanced nature of the review are organized in a timely manner. It also stipulates that the review period should not exceed 5 years in principle.

7. About Standard Implementation and Supervision

The "Measures" clarify the implementation and supervision requirements of mandatory standards, recommended standards and product technical requirements.

Article 25 stipulates that medical device enterprises should organize production in strict accordance with the registered or filed product technical requirements to ensure that the medical devices that leave the factory meet the mandatory standards and registered or filed product technical requirements. The status of mandatory standards in the supervision of medical devices is emphasized.

Article 26 emphasizes that once the recommended standards are cited by laws and regulations, normative documents, and registered or filed product technical requirements, they should be enforced. The implementation requirements of recommended standards for medical devices in corresponding situations are clarified.

Article 27 clearly stipulates that the technical requirements of medical device products shall not be lower than the mandatory national standards and mandatory industry standards applicable to the products, establishing the connection between product technical requirements and mandatory standards.

Article 28 requires the food and drug administration to supervise and inspect the implementation of mandatory medical device standards by medical device companies and the technical requirements for registered or filed products.

At the same time, in order to strengthen the evaluation of the implementation of medical device standards, Article 32 clarifies that the medical device standardization technical committee or technical focal point shall track and evaluate the implementation of the standard, and stipulate that the medical device standard management center shall conduct statistical analysis on it, In order to realize the closed-loop management of medical device standards and continuously improve the standard quality.

8. About group standards

Article 34 of the "Measures" adds the content of group standards, and encourages social groups established according to law to formulate and publish group standards, and their management shall comply with relevant state regulations. This clause increases the effective supply of medical device standards, promotes the supply-side reform of medical device standards, and connects with the overall thinking of the national standardization reform, which better responds to innovation in the field of medical devices and the market's demand for standards.