China medical device QA/RA blog

News and commentary on regulatory changes.

Changes to Chinese Medical Device Regulations would Benefit Foreign Manufacturers

EMERGO SUMMARY OF KEY POINTS:

  • Chinese regulators have drafted changes to Order No. 650 covering various medical device regulatory requirements.
  • Proposed changes would affect product test reports, clinical evaluation report (CER) requirements, importing of innovative devices, and more.
  • The Chinese government has not yet announced firm implementation timeframes for these changes.

China medical device regulatory changes to Order No. 650 2018The Chinese government has issued draft changes to the country’s medical device regulatory framework that would allow easier market access for foreign manufacturers.

The China Ministry of Justice issued a notification (link in Chinese) for modification of Order No. 650, with broad implications for Chinese medical device market registrants upon implementation. The draft changes to Order No. 650 cover issues including product test reporting requirements, home-country approval certifications, clinical evaluation reports (CER) and Unique Device Identification (UDI).

Summary of changes to Chinese medical device regulatory requirements

According to Emergo consultants in Guangzhou and Hong Kong, Chinese regulators have not yet announced any implementation timelines for the proposed changes to Order No. 650. Draft changes include:

  • Product test reporting: China Food and Drug Administration (CFDA) registrants may submit either self-test reports or test reports obtained from qualified organizations.
  • Imported innovative devices: Innovative medical devices imported into China would not require home-country approval certificates.
  • CER requirements: Class II medical devices would not be required in principle to provide CERs in their CFDA premarket applications.
  • Legal manufacturer definitions: The official definition of medical device legal manufacturer would be changed to that of marketing authorization holder.
  • UDI: CFDA plans to roll out a UDI system for the Chinese medical device market in the near future.
  • Stiffer penalties: Companies and individuals would face stiffer penalties for illegal acts, up to and including permanent prohibition from the Chinese market and jail time.
  • Crackdown on used devices: Importing or distributing used medical devices in China would be forbidden.

We will provide further details and analysis of changes to Order No. 650 and its impact on Chinese medical device market registrants as we learn more.

Related Chinese medical device regulatory resources:

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