Medical devices governmental regulation

The Ministry of Health, Labour and Welfare is the governmental body responsible for enacting legislation for pharmaceutical affairs. The regulation of clinical trials and new drug approval in Japan is based on the Pharmaceutical Affairs Law and related ordinances. The objective of the Ministry is to secure a safe medical environment through a consolidated structure of accurate reviews of pharmaceuticals and medical devices and postmarketing safety measure implementation. 

As the intended use of a biomaterial, either alone or in combination with other biomaterials in medical devices or prostheses, is to assist in the health and welfare of humans, governmental regulation of the biomaterial or medical device is required to ensure appropriate and adequate safety and efficacy of the biomaterial or medical device. In this regard, it is noteworthy that the Food and Dmg Administration (FDA) does not... 

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