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The Medical Device Authority (MDA), the department of the Ministry of Health in Malaysia, published draft guidance dedicated to notification of refurbished medical devices.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...
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The Food and Drug Administration (FDA), the US agency responsible for medical device regulation, has published a list of Class I and Class II medical devices exempt from the obligatory premarket notification requirement. Scope of Exemption According to the general...
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The Malaysian Medical Device Authority (MDA) issued official guidance dedicated to notification for orphaned medical devices. Scope of the Guidance The document was published by the MDA in order to assist all parties involved in operations with medical devices to...
Australia and Oceania
The Therapeutic Goods Administration (TGA), a division of Australia’s Department of Health responsible for medical devices circulation, issues new guidance dedicated to the evidence requirements. The new guidance published by the TGA is intended to provide entities...
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...
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