On Feb 27th, China Food and Drug Administration (CFDA) published their inspection reports for the following eight international medical device manufacturers under its Medical Device Good Manufacturing Practice:

• Terumo Corporation (Japan)
• Shimadzu Corporation (Japan）
• St. Jude Medical Cardiac Rhythm Management Division (U.S.)
• Covidien LLC (U.S.)
• William A. Cook Australia Pty, Ltd. (Australia)
• 3M Health Care (U.S.)
• NovaBone Products LLC (U.S.)
• Synthes GmbH (Switzerland)

CFDA began to publish these oversea inspection reports on its website starting from November, 2017.  On December 15, 2017, CFDA suspended the import authorization of a medical device due to severe deficiencies observed during an on-site inspection.  The product is HER-2 Test Kit manufactured by Leica Biosystems Newcastle, Ltd (U.K.)

While CFDA had identified cGMP deficiencies in each of the above manufacturers’ practices, and asked these companies to provide a written response (in both English and Chinese) with corrective actions within 50 working days, none of these observations appear to be major or critical deficiencies that warrant follow-up enforcement actions from CFDA.

A closer look at these observations reveals that some of these international companies are either unaware of the Chinese legal requirements for medical device manufacturing or simply assume their quality system will pass muster.  For example, in the inspection report issued to William A. Cook Australia Pty, Ltd., CFDA found that the company did not even reference Chinese Medical Device Good Manufacturing Practice and associated appendices in the manufacturer’s quality handbook.  It is, therefore, prudent for medical device manufacturers to assess whether their current quality system will meet the Chinese legal requirements and document their gap analysis.

CFDA also plans to conduct more oversea inspections of pharmaceutical manufacturers.  According to CFDA’s published work plan, a total of thirty-three oversea pharmaceutical manufacturing sites will be inspected in 2018.