Interpretation of the Notice on Registration of Medical Device Master Files

Interpretation of Announcement on the Registration of Main Documents of Medical Devices

Recently, the National Medical Products Administration issued the Announcement on the Registration of Main Documents of Medical Devices (No. 36 of 2021) (hereinafter referred to as the 'Announcement'). The background, main principles, and key issues of the Announcement are explained below:

I. Background

In recent years, the industry has been increasingly calling for encouragement of innovation, improvement of the registration and declaration process, and avoidance of repeated submission of registration and declaration materials. In order to implement the opinions of the Central Committee of the Communist Party of China and the State Council on Deepening Reform of the Approval System and Encouraging Innovation in Drugs and Medical Devices, as well as the State Council's Opinions on Reforming the System for the Evaluation and Approval of Drugs and Medical Devices, and further improve the quality of evaluation and approval of medical devices, establish a more scientific and efficient evaluation and approval system, encourage innovation, facilitate medical device manufacturers to choose raw materials and key components, and simplify registration and declaration, the National Medical Products Administration conducted in-depth research and listened to opinions from all sides, and consequently issued this Announcement.

II. Main principles

The content of main documents for medical devices mainly involves medical device raw materials, etc. Referring to international relevant requirements and combining with the practical situation of medical device registration in China, the Announcement stipulates that the registration of main documents shall be based on a voluntary principle. The owner of the main document voluntarily submits it to the regulatory authority for registration, without substantive evaluation during registration, and it will be evaluated together with the associated medical device registration application. When the applicant for a medical device needs to use the main document information in the application for market registration, the owner of the main document shall issue an authorization to the applicant for the medical device. The applicant for the medical device shall submit the authorization as part of the declaration materials to replace the registered main document information. When the regulatory authority evaluates the declaration materials for the medical device, it may refer to the registered main document information based on the authorization. When different medical devices use the same main document, it can avoid the repetition of technical data submission and evaluation.

III. Key issues

(1) How to apply for the registration of the main document for a medical device

For the specific methods of applying for the registration of the main document, please refer to the relevant notices published on the website of the Medical Device Technical Evaluation Center of the National Medical Products Administration.

(2) Will the registration of the main document affect the responsibility subject for the safety and effectiveness of the medical device

The registration of the main document is not an administrative licensing item, but a measure in the management of medical device registration. It will change some of the ways in which declaration materials are submitted. The implementation of the registration of the main document for medical devices will not change the main subject responsibility of the medical device applicant (registrant) for the safety and effectiveness of the final medical device product. The responsibilities and obligations of the owner of the main document shall be agreed in the form of a contract with the medical device applicant (registrant). Therefore, the subject of medical device regulation and responsibility is still the medical device applicant (registrant), not the owner of the main document. The medical device registrant shall guide and assist the owner of the main documents to establish the main documents in accordance with the relevant requirements for the registration and declaration of medical device materials. The medical device registrant shall be fully responsible for the declaration materials submitted by it.

(3) Confidentiality principles

The confidentiality principles and measures for the registration and declaration materials of medical devices shall also apply to the main document materials.