Dec 17, 2013

The China Food and Drug Administration (CFDA) implemented a simplified certification renewal process on January 1, 2014 for medical devices. With the exception of devices with major changes, manufacturers seeking to renew their medical device registrations in China will face fewer documentation requirements and potentially faster re-certifications.

According to a CFDA notice (link in Chinese), manufacturers with no changes to their devices to report during certification renewal will need to provide declarations stating that no product changes have been made, and that their devices comply with current CFDA requirements. Registration renewal applicants will no longer have to submit product standards, CFDA test reports or user manuals.

New and revised requirements for renewals due to manufacturing site changes have also been announced: For manufacturing site changes for medical device companies based in China, CFDA should be provided with declarations stating that only the companies’ sites (not their products) have changed; inspection reports of quality system compliance at the new manufacturing sites; and self-test reports on devices manufactured at the new sites. Foreign manufacturers with manufacturing site changes to report should provide CFDA with declarations that their sites have changed; supporting material including quality management certifications for their new sites; and self-test reports of their devices made at their new sites.

In instances where manufacturing site changes are the only changes renewal applicants have to report, their applications will go directly into the CFDA administration approval process.

Certification renewal applicants with intended use changes to report should submit declarations that only the intended use of their devices has changed; relevant clinical trial documentation and risk analysis to support intended use changes; and comparison tables showing associated changes made to device user manuals.

CFDA registration renewal applicants with changes to model, specification, product standard or product structure no longer have to provide full product standards, CFDA test reports or user manuals to Chinese regulators. Required submissions in these cases include:

  1. Comparison tables listing product changes and explanations
  2. For product standard changes, lists of modifications made to those standards
  3. Comparison tables listing user manual changes
  4. Risk analyses of reported changes’ impact on intended use
  5. CFDA test reports on safety and performance of changed products

The CFDA still requires complete renewal registration dossiers for medical devices in which changes to their basic principles have occurred, or for devices with major changes to their intended use, structure, design, performance, functionality or material.

Stewart Eisenhart


  • Stewart Eisenhart