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The Medical Device Authority (MDA), the department of the Ministry of Health in Malaysia, published draft guidance dedicated to notification of refurbished medical devices. The document is intended to assist industry representatives and provide them with the...
Asia
The Ministry of Health, Labour and Welfare of Japan (MHLW), the Japanese regulating authority responsible for medical device circulation, issued updated guidance dedicated to biocompatibility testing of medical devices. Biocompatibility Testing Standards According...
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The Health Sciences Authority (HSA), Singapore’s medical device regulating authority, has published the new revision of the guidance on medical device field safety corrective actions. General Overview of the Field Safety Corrective Action The recent guidance...
Asia
Japan announced the adoption of the new version of the Pharmaceuticals and Medical Devices (PMD) Act, the core document regulating the Japanese sphere of medicines and medical devices. New Japanese Medical Device Regulations: an Overview The novelties introduced in...
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Health Canada, the Canadian medical device regulating agency, has issued new guidance on software as a medical device (SaMD) to provide details on definition and classification. The Scope of the Guidance The new guidance describes certain aspects of the...
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