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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...

Mexico: New regulation for medical devices   Mexico has published a draft Mexican Official Standard PROY-NOM-137-SSA1-2024 on the labelling of medical devices. The notified draft Mexican Official Standard is mandatory throughout Mexican territory for establishments involved in the manufacture, packaging, distribution and import of medical devices to be marketed or supplied in Mexico. The notified...

EU: Longer transition period for the Medical Devices Regulation   EU published a Proposal for a Regulation amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. Regulation (EU) 2017/745 on medical devices (MD Regulation) and Regulation (EU) 2017/746 on in vitro diagnostics...

EU: New Guidance on the difference between medical devices and medicinal products   The EU Medical Device Coordination Group has published a new document: A Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices. The reason for this guidance is a blurred difference between the two legal definitions:...

USA: Quality System Regulation Amendments for medical devices and harmonization with international standards   The American Food and Drug Administration (FDA) has proposed to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with the international consensus standard for medical devices. This may happen by...