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...
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...
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...
Asia
Philippines Food and Drug Administration (FDA), the national authority responsible for medical devices market regulation, has announced the implementation of a new regulatory framework for medical devices. New Medical Device Regulation: General Principles and...
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