I wanted to share some insights about the NMPA's Medical Device Evaluation proposal submitted to IMDRF. It is quite a milestone for China's regulatory development and harmonization effort with rest of the world.
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 passed 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 is now available for public consultation: http://www.imdrf.org/consultations/cons-clinical-evaluation.asp. The feedbacks need to be submitted by June 5, 2019.
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.
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 more in line with the international clinical standards.
I hope this was helpful. Has anyone ever submitted your overseas clinical data to NMPA or are currently going through this process? I'd love to hear about your experience(s).
If you have any questions or want more information, feel free to send me a message or email at gpalma@chinameddevice.com.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------