Japan's Ministry of Health, Labor, and Welfare (MHLW)

The MHLW is Japan's primary regulatory body for creating and implementing safety standards for medical devices and drugs. Within the MHLW, the Pharmaceutical and Food Safety Bureau is in charge of pharmaceutical and medical device regulatory policy.

The MHLW conducts evaluations of all new or improved medical devices, and conducts equivalence reviews for generics. It has the authority to conduct site inspections to ensure Good Manufacturing Practice (GMP), halt clinical trials, and make the final decision on whether to approve a pharmaceutical or medical device.

In addition to approving pharmaceuticals and medical devices, the MHLW also works to promote the development of the medical devices industry. In accordance with its "Vision of the Medical Device Industry," the MHLW has undertaken measures to promote clinical trials, train hospital staff, improve the efficacy and safety of medical devices, and support the research and development of new technology. The MHLW also works closely with international organizations and foreign governments to promote global regulatory harmony.

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