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Vietnam Amends Medical Device Regulations – 2019
The Government of Vietnam, at the proposal of the Minister of Healthcare, has published a decree amending and supplementing national medical device regulations. The proposed amendments aim to modify a wide scope of...
MFDS Amended Submission Requirements
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...
MDA Malaysia’s Guidance on Combination Products
The Medical Device Authority (MDA), Malaysia’s agency for regulating medical device manufacturing, importation, and distribution, issued guidelines for the registration of drug-device and device-drug combination...