The 2017 Highlights from the Published CFDA Medical Device Registration and Regulation Reform

CFDA just published a visual illustration of its current reform in medical device registration and regulation.

As highlighted, CFDA are focusing in these FOUR AREAS from this round of medical device reform:

• Product classification regulation

• Review and approval policies

• Clinical trial monitoring and audits

• Action plan to enhance quality standards

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In particular, in 2017 CFDA pushed these EIGHT MEASURES to improve its registration and regulation management on medical devices:

1. Following the “Process for Medical Device Priority Approval”, provide priority review and approval to medical device products that treat malignant tumors, rare diseases and for pediatric use, and with demonstrated clinical advantage, urgent unmet needs, national Sci-Tech important special projects, or supported by major R&D plans.

2. Deepen implementation of the “Special Registration Process for Innovative Medical Device”; Strengthen guidance on innovative medical device registration; Motivate R&D innovation.

3. Advance reform of medical device classification and regulation, establish technical committee for classification, issue new version of “Medical Device Classification Catalogue” and associated supporting documents, ensure smooth transition from old to new version.

4. Issue “Management Approaches of Medical Device Standards”, normalize establishment and revision of quality standards, align with international standards.

5. Further optimize clinical trial monitoring and audits.

6. Promote the implementation of government purchase service pilots for medical device registration review projects, strengthen review facilities.

7. Continue to enhance guidance, monitoring and evaluation of review and approval capabilities at provincial and regional level.

8. Further refine and optimize review and approval process of medical device registration, provide open and timely information

China Med Device, LLC, specializes in CFDA registration related services and market research for medical device products in China. If you would like to know more about this report or tap into China’s fast-growing medical device market and accelerate your medical device’s entry in China, please contact us at info@ChinaMedDevice.com or visit us at http://www.ChinaMedDevice.com.