Medical device registration system verification: the following circumstances can be exempted!

Beijing Municipal Drug Product Admintration recently issued the Guiding Principles for Optimization and Verification of Beijing Medical Device Registration Quality Management System (Trial) and the Guiding Principles for Suspension of Inspection of Beijing Medical Device Registration Quality Management System (Trial).

The judgment principles of not starting verification, exemption from on-site inspection and termination of verification are clarified:

Judgment principles of not starting verification

1. For the registration and verification items of the Class II medical device products, if they meet one of the following circumstances and the production address and conditions of the products remain unchanged, the verification can not be started in principle:

2. If the applicant does not apply for renewal of registration 6 months before the expiration of the registration certificate of medical devices, the registration shall be handled as the first registration, and the products have not changed;

3. The changes in the registration items of medical device change reported by the registration applicant do not involve changes in the production technology;

4. The product has been registered and passed the registration verification of the original product within 2 years of this application, but the registration application is withdrawn due to the reasons of the registration applicant, and the product has not changed.

Judgement  principle of exemption from on-site inspection:

1. In one of the following situations, if the production address of the product does not change, registration verification shall be started, and in principle, on-site inspection can be exempted:

2. For the Class III medical device product registration verification, the product has been registered, and passed the registration verification of the original product within 2 years of the application, the registration application is withdrawn due to the reasons of the registration applicant, and the production conditions and production process of the product have not changed;

3. For the Class II medical device registration applicants who have obtained the production license, the in vitro diagnostic reagents applied for registration belong to the same methodology in Schedule 1 as the products for which the registration applicant has obtained the medical device registration certificate, or the medical devices applied for registration belong to the same second-level subdirectory in the Catalogue of Medical Devices Classification;

4. For registration applicants who have passed the on-site inspection of the medical device registration quality management system at least once within 2 years, and the medical device products registered this time have been compared with the registration applicant who has checked the production conditions and processes of the products and have the same working principle and intended use. And having basically the same structural composition, production conditions, production technology.

III. For class II/ class III medical device registration applicants who have passed on-site inspection of medical device registration quality management system at least once within 2 years and whose product production address does not change, on-site inspection items can be optimized in principle, focusing on the authenticity verification of testing products and clinical trial products used for registration

In principle, on-site inspection shall not be exempted or optimized if one of the following conditions is met

1. The registration applicant violates the relevant national laws and regulations on medical devices within 2 years and is investigated and investigated according to law;

2. The dishonest enterprises are displayed on the Beijing Enterprise Credit Platform in real time;

3. The applicant for registration is in the state of production suspension.

 Determination principle of suspension of inspection

If any of the following situations occur during the on-site inspection, the inspection shall be suspended:

I It is difficult to continue the inspection due to force majeure or other objective factors;

II. It is found that the applicant for registration is suspected of having committed any illegal act of concealing the true situation or providing false information;

III .    Other circumstances consistent with the suspension of inspection.

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Source：Beijing Municipal Drug Product Admintration ,CMDRA

Translated & edited : Bradyknows