The Pharmaceuticals and Medical Devices (PMD) Act establishes the Regulatory framework for controlling pharmaceuticals, cosmetics, in-vitro diagnostic reagents, medical equipment, and regenerative and cellular therapy items on the Japanese market.

As of November 25, 2014, the Japanese Pharmaceutical Affairs Law (also called JPAL) was revised with its title modified to “Act on Securing Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics” (abbreviated because of the PMD Act).

Japan’s Ministry of Health, Labor, and Welfare (MHLW) administers and oversees the PMD Act.

Modifications from JPAL to PMD Act

• In Japan, the Marketing Authorization Holder (MAH) is responsible for Quality Management System (QMS) and Good Vigilance Practice (GVP)
• The QMS audit will assess all design control procedures for Class II devices (Article 30-36, ISO 13485 Clause 7.3)
• Standalone software qualifies as a Class II device
•  It will be necessary for manufacturers to "be registered."
• Until the certificate's expiration, the present license or accreditation will remain in effect
• The rules for package inserts have changed, and Class IV devices and pharmaceuticals will now require pre-market submission (Todokede) of the package insert to the PMDA
• Manufacturers need a representative in Japan to engage on their behalf with the Registered Certified Bodies (RCBs) and Regulatory bodies
• To meet the criteria, manufacturers without a Japanese office must have an MAH

Key Points for Adhering to the PMD Act

• For Class II, III, and IV items, as well as for some Class I products as stated by the MHLW, the QMS for medical devices outlines the requirements
• The GVP for medical devices outlines the specifications for items in classes I, II, III, and IV
• A medical device single audit program (MDSAP) certificate will be accepted as a substitute for the on-site evaluation for MO No. 169 by PMDA/MHLW and Certification Bodies. The QMS audit will examine all design control procedures for Class II devices (Article 30-36, ISO 13485 Clause 7.3)

Consult with Freyr's experts to thoroughly understand Japan's pharmaceutical legislation for a seamless transition into the market. You can meet every demand with the assistance of our Regulatory experts. Consult Freyr today!