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To assist medical device manufacturers in maintaining compliance with applicable requirements, the National Health Regulatory Authority (NHRA), the Kingdom of Bahrain’s agency responsible for medical device regulation, has published registration guidelines. Bahrain...
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...
North America
The FDA, the regulating authority in the sphere of medical device circulation of the United States, issued guidance providing additional information on new pilot conformity assessment procedures. ASCA: key points The Accreditation Scheme for Conformity Assessment...
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