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Canada: Updates to the medical devices regulation    Canada has published updates to its medical devices regulation: Regulations Amending the Medical Devices Regulations (Establishment Licences).  The amendments to the Medical Devices Regulations (MDR) are intended to modernise the Medical Device Establishment Licence (MDEL) framework to better reflect an increasingly innovative medical devices sector while maintaining effective regulatory oversight to address emerging health and safety risks. They aim to...

Great Britain: Regulatory updates for medical devices   The United Kingdom as published a new Medical Devices (Amendment) Regulations 2026. The measures will amend the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) as applicable in Great Britain (GB). The amendments seek to update the pre-market requirements that manufacturers must meet before placing...

EU: Medical devices – expansion of the list of well-established technologies    The European Commission has issued a new delegated regulation under the Medical Devices Regulation (MDR). This initiative proposes to broaden the list of well-established technologies (WET) referenced in Regulation (EU) 2017/745, aiming to exempt these devices from certain legal requirements and thereby reduce...

Canada: Updates to Medical Devices Regulation   Canada has published Regulations Amending the Medical Devices Regulations. This proposal implements Phase II of Health Canada’s commitments outlined in the Departmental Forward Regulatory and Stock Review Plans to modernize the Medical Device Establishment Licensing (MDEL) framework, while enhancing oversight to better address emerging health and safety risks....

Mexico: Draft Mexican Official Standard PROY-NOM-241-SSA1-2024, Good manufacturing practices for medical devices   Mexico has published an interpretative guidance for the Draft Mexican Official Standard PROY-NOM-241-SSA1-2024, Good manufacturing practices for medical devices. Interpretation Criteria for the Mexican Official Standard NOM-241-SSA1-2025: Good Manufacturing Practices for Medical Devices For the purposes of Section 5 and any sections...

Mexico: Draft Mexican Official Standard PROY-NOM-241-SSA1-2024, Good manufacturing practices for medical devices.   Mexico has published two additional documents with regard to the Draft Mexican Official Standard PROY-NOM-241-SSA1-2024, Good manufacturing practices for medical devices. – Agreement issuing Guidelines for the submission of documents guaranteeing good manufacturing practices for pharmaceuticals, medicines, and medical devices accompanying applications...

Mexiko: Neue Verordnung für Medizinprodukte Mexiko hat einen Entwurf des offiziellen mexikanischen Standards PROY-NOM-137-SSA1-2024 zur Kennzeichnung von Medizinprodukten veröffentlicht. Der notifizierte Entwurf des offiziellen mexikanischen Standards ist in ganz Mexiko für Unternehmen verbindlich, die an der Herstellung, Verpackung, dem Vertrieb und dem Import von Medizinprodukten beteiligt sind, die in Mexiko vermarktet oder geliefert werden sollen. Der notifizierte...