Uncategorized
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...
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...
#WednesdayWebinar Join us for our upcoming webinar Global Regulatory Changes to Expect in 2025 January 22, 2025 at 10 AM ET
Register Now
