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[2025-09-19] (Open Access) Malaysia’s Medical Device Authority (MDA) announced its recognition as an affiliate member of the Medical Device Single Audit Programme(MDSAP) via its website on September 19, 2025. For the record: The MDSAP is a unique audit program designed to verify the compliance of a company’s Quality Management System
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[2025-09-23] (Open access) Delegated Regulation (EU) 2025/1920 on the unique identification of optical medical devices (spectacle frames, spectacle lenses and ready-to-wear reading spectacles) was published in the Official Journal of the European Union on September 23, 2025. It follows the public consultation we reported on earlier this year. We invite
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[2025-07-25] (Open Access) The European Commission continues to publish the results of its survey of Notified Bodies (NBs) with regard to the availability of medical devices (MDs) and in vitro diagnostic medical devices (IVDDs), on the European Union (EU) market. This is the 14th update. Survey background The survey was
