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CFDA: CFDA Releases New Self-Assessment Reporting Requirements for Medical Device Distributors

6. July 2016
On June 7, 2016, the China Food and Drug Administration (CFDA) released the Notice on Regulating Distribution Activities in Medical Device Circulation. This Notice requires that distributors of Class II and Class III devices verify that they have been in compliance with “Medical Device Good Supply Practices” (GSPs) and other medical device regulations, for the past two years. Distributors are required to submit a self-assessment to the respective municipal CFDA by July 15, 2016.

In the course of the reports the distributors have to describe any violations and submit a plan on how to avoid them in the future. Egregious violations can result in stricter or even additional inspections done by municipal authorities, but the submission of a correct report can minder the sentence. The report should be truthful, since wrong information the omission of information can lead to penalties such as loss of license and other sanctions.

The self-assessment should focus on eight categories of violations:

  1. Relationships with unqualified suppliers, downstream distributors, and healthcare institutions
  2. Failure to comply with Medical Device Good Supply Practice requirements
  3. Errors during the fabrication of application documents
  4. Failure to obtain or renew distribution licenses for Class III devices
  5. Distribution of unlicensed products (particularly by domestic agents for imported devices)
  6. Distribution of products that fail to meet mandatory standards, technical requirements, or are obsolete or expired
  7. Failure to transport and store medical devices in accordance with their labels and package inserts
  8. Failure to establish and implement the appropriate testing and record keeping system for incoming and outgoing products.

When the distributor submits the report the municipal CFDA, the municipal CFDA will make an inspection. The municipal CFDAs then submits their report to the central CFDA. The central CFDA in Beijing will use this report for their own inspections. It is important that the reports be complete and accurate to avoid additional scrutiny and possible problems.

It is expected that there will be more announcements, revisions and changes to the CFDA regulations in the near future. You will find updated information in our news section on our website, where we will keep you informed regarding official announcements.

Please do not hesitate to call (UK: +44 2071931135, Rest of Europe: +49 69 2713769150, US: +1 773 654-2673) or email and we will be happy to answer questions.

MPR Author

About the author: Julian Busch is founder and managing director of MPR China Certification GmbH
Publisher: MPR China Certification GmbH

Tel.: +49 69 271 37 69 150