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Pharmaceuticals and Medical Devices Act (PMD Act)

Effective Date: 25 Nov 2014

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Japan’s Ministry of Health, Labor and Welfare (MHLW) is the regulatory body that oversees food and drugs in Japan, which includes creating and implementing safety standards for medical devices and drugs. In conjunction with the MHLW, the Pharmaceutical and Medical Device Agency (PMDA) is an independent agency that is responsible for reviewing drug and medical device applications. The PMDA works with the MHLW to assess new product safety, develop comprehensive regulations, and monitor post-market safety.

Japan PMDA regulations are laid out in the Pharmaceuticals and Medical Devices Act (PMD Act), also known as the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics. The PMD Act affects all aspects of Japanese medical product registration, including in-country representation, certification processes, licensing, and quality assurance systems. The PMD Act came into force on November 25, 2014 and replaced the Pharmaceutical Affairs Law (PAL).

 

Key features of the regulations include:

  • Some Class III medical devices are able to undergo third party certification.

  • Medical software programs are independently regulated.

  • Manufacturers are required to be registered rather than be licensed.

  • Quality management systems (QMS) are streamlined. QMS inspection is conducted on the Marketing Authorization Holder and is conducted per product family, not on individual products.

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