Registration process of the second class medical devices in Guangdong Province

Medical device registration refers to the process of systematically evaluating the safety and effectiveness of medical devices to be marketed and used in accordance with legal procedures to decide whether to approve their sale and use. Divided into domestic medical device registration and overseas medical device registration. Overseas medical devices, whether Class I, Class II or Class III, must be handled by the State Food and Drug Administration of Beijing; domestic medical devices of Class I and Class II shall be handled by the local provincial or municipal food and drug administration, and medical devices of Class III shall be handled by the State Food and Drug Administration. Medical device registration certificate refers to the legal identity card of medical device products. So what should I pay attention to when applying for the second class medical device registration certificate in Guangdong Province? Today, I will share the related problems and analysis of the second-class medical device registration certificate of the US Food and Drug Administration in Guangdong for your reference.

I. Basic information

Two. Acceptance criteria and conditions for the registration certificate of medical devices of category II

acceptance condition

1. The registered products have been listed in the Catalogue of Medical Devices attached to the Announcement of the General Administration on Issuing the Catalogue of Medical Devices (No.20 17 104), and the management category is Category II. (Note: For newly developed medical devices that are not listed in the classification catalogue, the applicant can directly apply for the registration of the third category of medical devices in China Food and Drug Administration, or judge the product category according to the classification rules and apply for product registration or filing after applying for category confirmation in China Food and Drug Administration. )

2. The applicant shall be an enterprise legally registered within the jurisdiction of Guangdong Province (the requirements of the applicant for the pilot system of medical device registrant shall be stipulated separately).

3. The applicant shall establish a quality management system related to product development and production, and maintain its effective operation. When applying for registration, samples may not be commissioned by other enterprises for production, except for products approved in accordance with the special examination and approval procedures for innovative medical devices or in line with the pilot requirements of the medical device registrant system.

4. Personnel handling medical device registration affairs shall have corresponding professional knowledge and be familiar with the laws, regulations, rules and technical requirements of medical device registration or filing management. Such as Regulations on the Supervision and Administration of Medical Devices, Measures for the Administration of Medical Device Registration, Rules for the Classification of Medical Devices, Notice on Further Improving the Classification and Definition of Medical Device Products, Notice on Printing and Distributing the Guiding Principles for the Preparation of Technical Requirements for Medical Device Products, Provisions on Clinical Trials of Medical Devices, Technical Guiding Principles for Clinical Evaluation of Medical Devices, Provisions on the Management of Instructions and Labels for Medical Devices, Notice of the General Administration on the implementation of the Measures for the Administration of Medical Device Registration and the Measures for the Administration of in vitro Diagnostic Reagents Registration, and announcement on the publication of the information requirements and approval document format of medical device registration, etc.

5. When applying for registration, the applicant shall follow the basic requirements for the safety and effectiveness of medical devices, and ensure that the development process is standardized and all data are true, complete and traceable.

6. The application materials for registration shall be in Chinese. If the translation is based on foreign materials, the original text should be provided at the same time. When citing unpublished documents, the supporting documents recognized by the data owner shall be provided. The applicant is responsible for the authenticity of the information.

7. The applicant for registration of the medical device registrant system in Guangdong Province shall meet the following conditions:

(1) The domicile is within the administrative area of Guangdong Province, which can be enterprises, R&D institutions and scientific researchers;

(2) Entrust an enterprise legally established within the administrative area of Guangdong Province to produce the product;

(3) Full-time personnel related to regulatory affairs, quality management, post-listing affairs, etc. Should be provided, and the above-mentioned personnel should have corresponding professional background and work experience, and shall not work part-time with each other;

(4) Having the ability of life cycle management of medical devices, and having the personnel and conditions for evaluating, auditing and supervising the quality management system;

(5) Have the ability to undertake the responsibility for the quality and safety of medical devices, and ensure that the development process is standardized and all data are true, complete and traceable. Note: A-level taxpayers with tax credit, reliable production and business units and their related personnel in the field of safety production, and advanced customs certification enterprises can refer to the priority approval procedures of Class II medical devices of Guangdong Drug Administration when registering Class II medical devices.

Three. The procedures for handling the registration certificate of Class II medical devices are as follows:

Four, the second kind of medical device registration certificate materials are as follows:

Verb (abbreviation of verb) The rights and obligations of the applicant.

The applicant shall enjoy the following rights according to law

If the legal conditions are met, the applicant has the right to obtain this administrative licensing decision. If the applicant refuses to accept the result of the administrative licensing, he has the right to apply for administrative reconsideration or bring an administrative lawsuit according to law. The applicant has the right to know, and the implementing organ shall inform the basis, conditions, time limit, process and requirements for handling the administrative licensing matters. In handling this matter, the applicant has the right of consultation, process inquiry and complaint.

The applicant shall perform the following obligations according to law

The applicant shall submit the application materials in accordance with the provisions. The applicant shall be responsible for the authenticity of the substantive contents of his application materials. The applicant shall actively cooperate with the implementing agency in handling the relevant work of this matter, including completing supplementary materials as required. The applicant shall have corresponding professional knowledge and be familiar with the laws, regulations, rules and technical requirements of medical device registration management.

Source: Guangdong Provincial Government Affairs Network

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