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Historical Changes on China Medical Device and IVD Registration Effective October 1, 2021

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The last time the “Medical Device Registration Administrative Measures” were completely overhauled was in 2014. The newer regulations with significant changes have been introduced focusing on expediting innovation, complete product life cycle, and post market penalty, after the state council revealed the highest decree Order 739,  “Regulation on the Supervision and Administration of Medical Devices” on March 16, 2021.

State Administration for Market Regulation, NMPA is a part of which, published the “Administrative Measures for the Registration and Filing of Medical Devices” and the “Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents” on August 31, 2021, with the implementation date of October 1, 2021.

Major Changes

The revised device registration regulation has 124 articles in 10 chapters, and the IVD regulation has 125 articles in 10 chapters. The key amendments include:

  1. Streamline the review process. Simplify the home-country-approval certification documents, device testing reports. For innovative medical devices that have not been approved overseas, it is no longer necessary to submit overseas certification documents. Reiterate that the applicants can submit the self-testing report.
  2. Innovate more ways of approval.. Further implement the Market Authorization Holder (MAH) system, clinical trial implied license, extended access for clinical trial, conditional approval system; Refine the innovation approval and priority review process; Strengthen the emergency approval system, based on the experiences from the coronavirus pandemic.
  3. Allow more versatile clinical evidence and reduce the burden of clinical trial. Simplify the clinical trial approval procedure. Adjust the clinical evaluation requirements. Re-clarify situations of clinical trial exemption and implied permission.
  4. Strengthen the life cycle management. Clarify the responsibilities of the national and provincial NMPA and technical institutions at all levels. Further define device testing and clinical trial on-site inspection requirements and improve clinical trial risk control.

We will do an in-depth analysis on the two measures. Please sign up our latest NMPA news HERE.

For an English copy of the two documents, please contact us at info@chinameddevice.com.