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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...
An Overview of Medical Device Regulations in Japan
In Japan, pharmaceuticals and medical devices are regulated by the Pharmaceutical and Medical Device Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW). The PMDA is an independent agency that works...