Uncategorized
The Medical Device Authority (MDA), the department of the Ministry of Health in Malaysia, published draft guidance dedicated to notification of refurbished medical devices.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...
Uncategorized
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...
Uncategorized
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...
Europe
The Medical Device Coordination Group (MDCG), the advisory body that consults the European Commission on the implementation of laws surrounding medical device circulation, issued guidance related to a new codification system to be used under the framework established...
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