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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...
Turkey Updates Its Medical Device Regulations
The Turkish Ministry of Health (TMH) recently published a draft regulation to update its current, European Union-aligned Medical Device Regulation. While most of the requirements proposed in the draft regulation are...
Medical Device Reimbursement in Japan
The majority of medical devices sold in Japan are paid for by the Japanese National Health Insurance (NHI) system via reimbursement, which is oftentimes an even more critical matter than regulatory compliance. In order...