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MHRA: standard model for PMSR

2025-10-01
[2025-09-05] On September 5, 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a standard template for the post-market surveillance report (PMSR) for…contenu réservé à nos abonnés Premium

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FDA : FAQ on QMSR

2025-10-01
[2025-08-27] In February 2024, the US Food and Drug Administration (FDA) published its final rule on the transition from the QSR (QS Regulation) to the…contenu réservé à nos abonnés Premium

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Malaysia becomes an affiliate member of MDSAP

2025-10-01

[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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HAS: CNEDiMTS assessment principles

2025-09-26
[2025-07-01] The Haute Autorité de Santé (HAS) website, which provides information on the evaluation of medical devices (MDs) for reimbursement purposes, was updated on July…contenu réservé à nos abonnés Premium

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