USA: Quality Management System Regulation Updates and FAQs: Final Rule Amending the Quality System Regulation - February/March 2024

• 2024-03-01 06:21:15

The FDA has released a final rule amending regulation amending the current good manufacturing practice (CGMP) guidelines for medical devices under the Quality System (QS) Regulation. This rule entails an amendment to 21 CFR 820, adopting the quality management system standards outlined in the ISO 13485:2016, established by the International Organization for Standardization (ISO).

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AUSTRALIA: FAQs for Software-Based Medical Devices – January, 2022

• 2022-01-26 08:15:53

TGA has already implemented reforms to the regulation of software-based medical devices from 25 February 2021. Under the new regulation, some software may be excluded from the TGA regulations, or although still regulated by TGA they may be exempted from the need to include the product in the ARTG. In the following, we gathered some FAQs and have summarised TGA’s article to help you have an insight on what is required to operate legally in Australia.

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FAQs for TFDA Good Distribution Practice (GDP)

• 2020-10-15 05:09:36

FAQs for TFDA Good Distribution Practice (GDP)

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