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BSI UK Named First Notified Body Under EU MDR
The British Standards Institution (BSI) United Kingdom (UK) has been officially designated as the first notified body (NB) under the Europe Union’s (EU) new Medical Device Regulation (MDR). This is the first NB to be...
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...