693367 2021-09-29 18:21:18.0 NMPA Announcement on Matters Concerning the Implementation of the Provisions for Medical Device Registration and Filing and the Provisions for In-vitro Diagnostic Reagent Registration and Filing Medical Device Registration, In-vitro Diagnostic Reagent Registration and Filing 48 16576 Laws and Regulations 2@NMPA /enpproperty-->

The Provisions for Medical Device Registration and Filing (SAMR Decree No.47) and the Provisions for In-vitro Diagnostic Reagent Registration and Filing (SAMR Decree No.48) (hereinafter collectively referred to as the Provisions) were issued and implemented as of October 1, 2021. In order to implement the Provisions, the relevant matters are hereby announced as follows:

I. Treatment to application projects already accepted for registration before implementation of the Provisions

For registration application projects already accepted before the implementation of the Provisions but with the approval decision not yet made, drug regulatory authority should continue the review and approval according to original provisions, and issue the registration certificate of medical devices for those met the marketing requirements. For registration renewal, the starting date of the validity period of registration certificate should follow Article 84 of the Provisions.

II. Test report involved in supplementary materials

For registration application projects already accepted before the implementation of the Provisions but with the approval decision not yet made, if the supplementary materials involve test report, the registration applicant shall entrust a qualified medical device testing institution to issue supplementary test report; If the QMS verification of the registration applicant covers the test capacity, the supplementary self-test report can also be submitted in accordance with the Provisions and relevant requirements.

III. Review of the application projects already accepted for registration before implementation of the new mandatory standards

Unless otherwise specified in the standard documents issued and implemented by NMPA, a medical device with the application already accepted for registration before implementation of the new standards can be reviewed and approved according to original provisions where the mandatory standards cited in the product technical requirements have changed. As of the date of implementation of the new standards, enterprises shall fully implement the new standards and their products shall meet the requirements of the new standards.

IV. Biological test of medical devices

If the biological evaluation of a medical device involves biological test, the applicant should submit the biological test report as part of the study materials when applying for registration. For biological tests, medical device testing institutions qualified for biological test shall be entrusted to carry out such tests according to relevant standards. Biological test reports issued by foreign laboratories should be attached with the quality assurance documents demonstrating its compliance with GLP laboratory requirements.

V. Registration (filing) forms for imported medical devices and domestically manufactured medical devices

For imported medical devices, overseas registration applicants (filing applicants) shall apply for registration (handle the filing). For medical devices manufactured in China by overseas enterprises, domestic manufacturing enterprises shall apply for registration (handle the filing) as the registration applicants (filing applicants).

VI. Filing of Class I medical devices

No clinical evaluation data shall be submitted for the filing of Class I medical devices.

VII. Documents related to medical device registration management

(I) After the implementation of the Provisions, the documents related to the medical device registration management listed in the attachment shall be abolished simultaneously.

(II) For items not covered in the Provisions, if there are explicit provisions in the medical device registration management documents previously issued by NMPA, such provisions shall still be implemented.