International Medical Device Regulators Forum (IMDRF) Committee Members meeting was held on September 17-19, in which China NMPA achieved two milestones. The commitments, on post-market-surveillance (PMS) and clinical evaluation, will propel China to be more synchronized with the international standards.
China NMPA became a member of the National Competent Authorities Report (NCAR) Exchange Program.
The NCAR Exchange Program is established to share medical device safety information among national regulatory agencies. Adverse incidents are evaluated and disseminated by members to prevent repetition of such incidents through the adoption of appropriate Field Safety Corrective Actions (FSCA).
According to final document developed by IMDRF, the following situations are required for info exchange:
Currently, more than 20 countries and regions have joined the cooperation. By participating in NCAR, China can identify and control the risks of imported devices in a timely manner, thereby improving the PMS system.
The Committee Members meeting also passed the NMPA (CFDA)’s final proposal of ” Medical Device Clinical Evaluation” The proposal was published on June 5, 2019 for feedback and the final document is now available on the IMDRF website: http://www.imdrf.org/consultations/cons-clinical-evaluation.asp.
The proposal includes three parts: clinical evidence, clinical evaluation and overseas clinical data. NMPA issued Guideline for Acceptance of Overseas Clinical Trial Data of Medical Devices on January 11, 2018. This guideline pertains to the acceptance of overseas clinical trial and evaluation data that are submitted by medical device and IVD registration applicants in China. It lists three Considerations for the Acceptance of Overseas Clinical Trial Data & Technical Requirements: Difference in Technical Review Requirements, Difference in Subjects, Difference in Clinical Trial Conditions. For our comments on the Guideline for Acceptance of Overseas Clinical Trial Data, please click HERE.
As a voluntary group of representatives from national medical device regulatory authorities and the industry members, IMDRF’s goal is the harmonization of medical device regulation across the world.
For our slides on NMPA Regulatory Updates that we shared at RAPS Convergence 2019, please email info@ChinaMedDevice.com.
For our webinar page, please click HERE.
China Med Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.