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MFDS Amended Submission Requirements Asia

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 regarding the scope of information and documents to...

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Medical Device Reimbursement in Japan Asia

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 to market their products in the country,...

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