Japan MHLW & PMDA Medical Device and Pharmaceutical Regulations

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.

The Pharmaceuticals and Medical Devices Act (PMD Act)

Current 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 Japanese Marketing Authorization Holder and is conducted per product family, not on individual products.

Japan Medical Device Classification

Under Japan PMDA regulations, a medical device can be classified as a General Medical Device (Class I), Controlled Medical Device (Class II), or a Specially Controlled Device (Class III and Class IV), depending on the risk level. For General Medical Devices, only a notification/self-declaration is required, and the product does not need to undergo the approval process by the MHLW and PMDA. Controlled Medical Devices can be designated to be certified by an authorized third-party certification party or reviewed by the PMDA. Specially Controlled Medical Devices must be reviewed and approved by the PMDA and MHLW.

Japan Drug Classification

The PMDA reviews new drugs, generic drugs, OTC drugs/”behind-the-counter” (BTC) drugs, and quasi-drugs, and conducts re-evaluations of previously approved drugs. Orphan drugs and other priority drugs are given priority reviews in accordance with their clinical significance.

PMDA reviewers consider the following five main points when evaluating a new drug to determine the approval status:

1. Has the reliability of the conducted studies and submitted documents been ensured?
2. Is the efficacy in the study population considered to be more effective than placebo according to the results of properly designed clinical studies?
3. Do the obtained results have clinical significance?
4. Are there any unacceptable risks as compared to the benefits?
5. Can the drug be supplied continuously with stable efficacy and safety from a quality assurance standpoint?

Regulatory Approval for Regenerative Medical Products

The PMDA regulations define cellular and tissue-based (regenerative medicine) products as processed human/animal cells or tissues that are intended to be used for:

1. The reconstruction, repair, or formation of structures or functions of the human body
2. The treatment or prevention of diseases
3. Gene therapy

The PMD Act significantly shortens the phased clinical trial period for regenerative medical products so that they can be used on a conditional authorization basis in a much timelier manner.

For more detailed information about product registration and regulatory requirements for medical devices and pharmaceuticals in Japan, please see Medical Device Registration in Japan and Pharmaceutical and API Registration in Japan.

Japan Medical Device and Pharmaceutical Regulatory Resources

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