As we eagerly anticipate the 14th China International Medical Device Regulatory Forum (CIMDR) from March 30 to April 4, 2024, we find ourselves reflecting on the invaluable insights gained from our participation in the 13th CIMDR in 2023. CIMDR, China’s premier medical device regulatory forum, is a crucial event where NMPA, CMDE, and experts convene to release the latest regulatory updates, shaping the future of medical device regulation in the country. This influential platform fosters collaboration and underscores a commitment to safety, efficacy, and innovation in the rapidly evolving field of medical devices in China. In this comprehensive overview, we navigate through the key takeaways from the 13th CIMDR, providing valuable insights into the evolving landscape of medical device regulation in China.

Progress in China’s Medical Device Registration Management

1. Continuous Enhancement of Regulatory Framework

Under the new regulations, the legal framework has taken shape across four hierarchical levels. Thirteen departmental regulations, 71 normative documents, 529 technical guidelines for registration review, and over 700 review key points have been issued. The coverage of medical device classification catalogue has surpassed 86%, accompanied by the publication of 1,934 medical device standards.

2. Implementation of the MAH System

The MAH system aims to establish a responsible entity throughout the entire lifecycle of medical devices. Key regulations such as the “Domestic Class III Medical Device Registration Quality System Verification Work Procedure,” “Guidelines for Quality Management System Verification of Medical Device Registration,” and “Guidelines for the Preparation of Annual Self-inspection Reports of Medical Device Quality Management Systems” have been successively released.

3. Strengthening Clinical Evaluation Management

The requirement for human clinical trials for the first-time registration of Class II and III medical devices has been reduced to approximately 10%. Regulations and guidelines related to clinical evaluation have been issued, and a comprehensive system for quality management and general requirements for clinical evaluation have been established, drawing inspiration from international guidelines and standards.

4. Encourage High-Quality Innovation of the Industry

In 2022, the NMPA received 343 innovation applications, with 68 entering innovation special review procedures and 55 obtaining approval for registration. By the end of 2022, a total of 528 products had entered special review procedures, resulting in the approval of 189 innovative medical devices. Additionally, 77 medical devices got prioritized approval in 2022, with a cumulative total of 126 approved by the end of the year.

5. Reinforcing the Construction of Registration Management Systems

The management of Class I medical device filings has been strengthened, with revisions to the “Catalog of Class I Medical Device Products.” A cleanup and standardization of the registration of domestic Class II medical devices are underway, focusing on addressing non-standardized registration documents and irregular review and approval processes. Actions are being taken against falsification of registration declaration materials, with penalties enforced according to the law.

6. Implementation of GB 9706.1-2020 and Supporting Standards

Preliminary statistics indicate that among the registered products in the market, at least 8,900 registrants and 26,000 registration certificates are affected by the implementation of the new standard. The industry is urged to prioritize compliance with this standard, as the implementation of mandatory standards is a legal obligation for registrants.

7. Further Release of Supporting Regulations

Upcoming regulations include “Measures for the Management of Self-developed and Used In Vitro Diagnostic Reagents by Medical Institutions,” “Provisions on the Emergency Use Management of Medical Devices,” “Measures for the Management of Medical Devices Developed by Medical and Health Institutions in Response to Public Health Emergencies,” and “Provisions on the Management of Imported Medical Devices Urgently Needed for Clinical Use.” These regulations are currently in the stage of publishing for feedback or piloting. They address specific and supplementary situations in the routine regulatory system, particularly focusing on urgent clinical needs.

China Med Device provides regulatory, CRO and commercialization one-stop solutions for medical device, IVD, CDx and combination products in China.  Please feel free to email info@ChinaMedDevice.com to set up an exploratory call. 

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• Source: https://chinameddevice.com/china-international-medical-device-regulatory-forum-cimdr/