How NMPA Reviews Imported Devices? Guideline Reveals

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The NMPA published the “Registration Review Guideline for Domestic Class III and Imported Medical Devices”, specifying working processes and timelines of registration application, clinical application and change application. The document also stipulates the responsibilities of NMPA, center of medical device evaluation (CMDE) and administration center.

As the releases of Order 739 and the medical device & IVD registration and filing measures, significant changes have been made in the complete product life cycle such as expediting innovation, streamlining premarket submission, and post market penalty.

These major regulations have impacts in new submissions in its format and content requirement particularly now it requires GMP related documents. In addition, clinical evaluation content and format need to be updated as result of the series of clinical evaluation related guidelines. E-filing (Electronic Regulated Product Submission, eRPS) flow also needs to be reorganized. To avoid rework, try to have your new registration accepted before the end of 2021.

Highlights of the Document

  • Applicants can go through E-submission system without submitting paper materials. If the paper documents are submitted, they shall be in the same format as the electronic submission catalog, and some required electronic documents shall be submitted at the same time.
  • Applicants will be notified in 5 working days if any documents are missing (submission deficiency)
  • Applicants will be notified in 30 days if the clinical trial can proceed.
  • Applicants have one year of time window to submit the missed materials.
  • Applicants shall pay the application fees in 15 working days.
  • Review shall be begun in 60 days after applicants submitted the missed materials
  • The technical review will be finished in 60 working days for domestic class III device, and 90 working days for imported devices.
  • The reviews will be conducted by two groups of people, the primary reviewers (division staff) and the secondary reviewers (division chief).
  • Applicants have 30 working days to complain if they are disagreed with the application results
  • The original submission materials shall be kept retrievable

To get an English copy of the “Registration Review Guideline for Domestic Class III and Imported Medical Devices”, please email info@ChinaMedDevice.com

For our recorded webinar “Navigating China’s New Regulatory Policy: Order 739”, please click HERE

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