Uncategorized
The Medical Device Authority (MDA), a special division of the Ministry of Health Malaysia responsible for medical device regulation, has announced new rules introducing additional obligations for medical device manufacturers and other parties involved in medical...
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...
Uncategorized
ISO, the International Organization for Standardization, issued a new standard dedicated to the application of risk management to medical devices. Brief Overview of ISO standards ISO is an organization comprised of several national standards bodies. 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...
Asia
The Ministry of Food and Drug Safety (MFDS), Korea’s national authority responsible for medical device regulation (previously known as Korea Food and Drug Administration or KFDA) issued an update to the requirements regarding the scope of information and documents to...
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