How To Handle China Registration During The Transition Period From Old NMPA Requirements To New Requirements

The Administrative Measures for Registration and Filing of Medical Devices (Order No. 47) and the Administrative Measures for Registration and Filing of IVD (Order No. 48) (hereinafter the Measures) have been issued and take effective since October 1, 2021. In order to implement the related measures, NMPA published the notices on the relevant matters of technical review during the transition period. Some key issues are listed as below.

1.NMPA Acceptance

1.1 Acceptance adjustment

• Since October 1, 2021, the application on designated type testing of medical device for registration will no longer be accepted.
• Since October 1, 2021, if there is any change in the original IFU after review, the registration applicant shall, in accordance with the requirements of Article 16 of the Provisions on the Administration of Instructions and Labels of Medical Devices, modify the IFU or handle the notice of IFU change according to the change document.

1.2 Modification registration and modification filing

Since October 1, 2021, if the registered products have changed as specified in the Measures and need to conduct modification registration and modification filing, the registrant shall apply for modification registration and filing separately.

1.3 Legal agent of overseas medical devices

Since October 1, 2021, overseas registration applicants and filling applicants shall designate an enterprise based in China as legal agent to handle the registration and filing of relevant medical devices. Representative offices established in China by overseas registration applicants and filling applicants shall not act as legal agent.

1.4 Renewal

For renewal of medical device certificate, the registrant shall apply the renewal 6 months ahead of expiry date on certificate, and submit related dossiers.

2.NMPA Review

2.1 During NMPA review on the accepted registration of medical device before the implementation of new mandatory standards, NMPA will remind the applicant in the supplementary notice about new mandatory standards effective soon, and recommend the applicant to implement new standards, modify product technical requirement (PTR), supplement type testing report and research documents.

If the applicants accept the recommendations from NMPA and submit supplementary documents, NMPA will review as per new standard; if the applicants do not accept the recommendation and not submit related documents, NMPA will review as per old standard.

If NMPA review as per old standard, but the product upgrade to new standard is the modification mentioned in the Measures, the applicant shall conduct modification after approval of medical device certificate.

2.2 During the renewal, if the renewal was accepted before Oct 1, 2021, NMPA will notify to supplement the dossiers for new mandatory standards.

Since Oct 1, 2021, if new mandatary standards have taken effective, and the products upgrade to new standards is mentioned in the Measures, the applicant shall conduct modification first before renewal.

For full version of this NMPA notice, please reach out to us via info@inspirativemed.com, or visit https://www.inspirativemedical.com/category/documents-download/