May 9, 2022
Asia
The new article describes in detail the approach to be applied by a party responsible for a medical device when notifying the regulating authority about the changes to the product already placed on the market. Table of Contents The Health...
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May 3, 2022
Asia
The article provides an overview of the regulatory requirements related to change notification for medical devices that are already placed on the market. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency...
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Oct 7, 2021
Europe
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s regulating authority, has initiated a public consultation regarding the regulatory framework for medical devices. In particular, the authority encourages medical device manufacturers and other...
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Sep 14, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to deciding when to submit a 510(k) for a software change to an existing device. Table of Contents The...
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Aug 31, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), Australia’s regulating authority in the sphere of healthcare products, has published a final document describing the refinements to the personalized medical devices framework. The new regulatory approach announced by...
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