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Join date: Sep 4, 2018

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Apr 2, 20263 min
Malaysia Updates Medical Device Labelling Guidance to Support Digital Labelling
Malaysia has taken another step toward modernising its medical device regulatory framework with the release of the 7th Edition of the Guidance Document on Requirements for Labelling of Medical Devices . The update was issued by the Medical Device Authority (MDA), introducing revisions that expand the use of digital labelling and improve accessibility of device information for users. The updated guidance, known as MDA/GD/0026 , provides manufacturers with clearer direction on labelling...

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Mar 23, 20262 min
Belgium Strengthens Medical Device Oversight Through National Regulatory Authority
Belgium continues to play an important role in the European regulatory landscape for medical devices, with a strong focus on compliance, safety monitoring, and alignment with European regulatory frameworks. The country’s national regulator, the Federal Agency for Medicines and Health Products (FAMHP), oversees the regulation of medicines and medical devices placed on the Belgian market. As the European Union continues to implement the European Union Medical Device Regulation (EU MDR) and the...

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Mar 19, 20262 min
Switzerland Strengthens Medical Device Oversight Under Swissmedic
Switzerland continues to reinforce its regulatory oversight of medical devices as part of its commitment to maintaining high standards for patient safety and product quality. In recent regulatory updates, the Swiss authority has emphasised the importance of robust market surveillance and regulatory compliance for manufacturers placing medical devices on the Swiss market. The country’s regulator, Swissmedic, plays a central role in ensuring that medical technologies available in Switzerland...

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