On March 21, 2019 the draft proposal of ” Medical Device Clinical Evaluation”, submitted by NMPA (CFDA) at the 13th International Medical Device Regulators Forum (IMDRF) management committee meeting, was approved by its stakeholders and members. China is the country chairing the clinical evaluation committee. A lot of efforts and research have been put in the key members of NMPA (CFDA) to work with member countries. The draft documents will soon be available on the official website of IMDRF (http://www.imdrf.org) for comments from global medical device regulators and industry stakeholders.
The draft 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. If you need to assess the possibility of whether your available overseas clinical data will meet NMPA (CFDA) acceptance criteria, we do have the methodology and service available to help you evaluate.
As a voluntary group of representatives from national medical device regulatory authorities and the industry members, IMDRF is responsible for harmonization of medical device regulation across the world. Once the draft proposal finalized, China is to be in line with the international clinical standards.
For our slides on Clinical Trials in China that we shared on RAPS annual meeting, please email info@ChinaMedDevice.com.
For our webinar on Key Ingredients for Effective China SDA (CFDA) and Clinical Trial, please click HERE.
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ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent overseas manufacturers for the complete product life cycle without their need to set up local entity in China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification.