GMP topical

26.01.2023

USA: Transition to ISO 13485 is getting closer

The US government's Office of Information and Regulatory Affairs has issued a timeline for harmonizing, or converting, the 21 CFR 820 with the European ISO 13485 for medical devices.

It is scheduled to become final by December 2023. The revisions are intended to promote the use of more modern risk management principles and reduce regulatory burdens on medical device manufacturers and importers by harmonizing domestic and international requirements (we previously reported).

Source:

Office of Information and Regulatory Affairs: Rule

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