Chinese FDA Requiring Self Inspections for Class II and III Medical Device Distributors

The China Food and Drug Administration (CFDA) has set a July 15, 2016 deadline for distributors of higher-risk medical devices to submit self-inspection reports.

The reporting requirements (link in Chinese) pertain to distributors of Class II and III devices, and although the rules primarily affect distributors, there are ramifications for manufacturers as well.

In particular, distributors will need to check their distribution records going back to June 1, 2014 and report on:

• Any Class II or III devices in their distribution networks that lack CFDA registration certificates
• Any devices under their purview that do not meet mandatory standards or technical requirements of their registrations
• Any devices that lack qualified and valid documentation
• Any devices with labels and/or Indications for Use that do not comply with current CFDA regulations
• Any instances where instructions and label indications for transport and storage of a device were not followed.

Manufacturers should follow up with their Chinese distributors to discuss self-inspection results and take any appropriate actions.