Hello Tonia,
If the company you are representing (not the one in China) is the Manufacturer (legal manufacturer) then in the Technical Documentation there should be an explanation of the manufacturing processes and any process validations performed. The medical device manufacturer regardless of what is sub-contracted, contract manufacturer, or supplier is still responsible for the finished medical device. When we assemble Technical Documentation files (EU MDR Annex II) there is a summary/short information about the manufacturing activities and any validations with then a reference to the specific work instructions, procedure, protocols, reports, etc. An external company like a sub-contractor or contract manufacturer would be identified as a crucial supplier (or use whatever term you would like, e.g. critical supplier). Then a reviewer can have an understanding of not only the manufacturing (product realisation) activities, but also who is performing different activities.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 11-Feb-2022 09:24
From: Tonia E. Bryant
Subject: Tech File Question
Greetings,
I have a question pertaining to technical files.
One of the technical files we are working for on is for a product that is entirely manufactured at our China facility. However, in the quality system, we treat them not as another facility, but as a supplier. Our quality system and the China quality system are completely independent (audited independently, registered independently, etc).
In this technical file, do we need to include any of the manufacturing processes, process validation, etc.? Or can we just point to them as a contract manufacturer and point to our purchase specifications, etc.?
Best, Tonia
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Tonia E. Bryant
Manager, Regulatory Affairs
Morrisville NC
United States
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