Overview

To promote innovation in medical devices, China's National Medical Products Administration (NMPA) revised the documentation regarding pre-assessment requirements for medical device registration on August 31st, 2022. According to Orders No. 48, No. 121, No. 122, and No. 76, China is committed to improving its approval process.

Medical Device Technical Review

The State Administration's Medical Device Technical Review Center will conduct a review of the application, ensuring that the submitted materials comply with the relevant standards. It's important to note that during the pre-assessment, the risk-benefit ratio and the safety and efficiency of the device will not be evaluated. The pre-assessment review is specifically limited to the applications for medical device registration, changes in licensing items, and clinical trial approvals.

Implementation of Revised Documents

The revised documents were issued and took effect immediately upon publication. Simultaneously, the NMPA’s Pre-assessment of Medical Device Registration (Order No. 42 of 2019) was abolished.

Attachments

1. Requirements for Pre-assessment of Medical Device Registration
2. Requirements for Pre-assessment of Medical Device Change Notification
3. Requirements for Pre-assessment of Medical Device Comparison Content for Clinical Trial
4. Requirements for Pre-assessment of Medical Device Clinical Evaluation
5. Requirements for Pre-assessment of In Vitro Diagnostic Medical Device Registration
6. Requirements for Pre-assessment of In Vitro Diagnostic Medical Device Change Notification
7. Requirements for Pre-assessment of In Vitro Diagnostic Medical Device Clinical Evaluation (Not Clinical Trial)
8. Requirements for Pre-assessment of In Vitro Diagnostic Medical Device Clinical Evaluation (Clinical Trial)
9. Requirements for Pre-assessment of Medical Device Clinical Trial Application
10. Requirements for Pre-assessment of Medical Device Renewal Registration
11. Requirements for Pre-assessment of In Vitro Diagnostic Medical Device Renewal Registration

Reference

https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20220831164520126.html?type=pc&m=