Japan PMDA Regulatory Requirements for Medical Devices and IVDs

Japan’s Medical Device Regulatory Requirements

Japan has a large aging population that demands high-quality care and strong healthcare outcomes for certain age-related conditions. Despite its strong domestic device manufacturing industry, Japan’s healthcare system still relies on imported devices, especially sophisticated medical technologies. However, the regulatory process is rigorous, expensive, and can be lengthy, particularly for novel and high-risk devices. Here’s a high-level look at medical device regulatory requirements in Japan.

Regulatory authority

Medical devices sold or distributed in Japan are regulated by the Pharmaceuticals and Medical Devices Agency (PMDA), which is a division of the Japanese Ministry of Health, Labor and Welfare (MHLW). PMDA enforces medical device regulatory requirements according to the Pharmaceuticals and Medical Devices Act (PMD Act).

Device classification

Medical devices are classified into four tiers of increasing risk: Class I, II, III, or IV. Manufacturers must also determine their Japan Medical Device Nomenclature (JMDN) code, which corresponds to a predicate device type. If there is no JMDN code for your product, it is considered new and may require a different regulatory pathway than devices in the same classification tier. IVDs are classified into three tiers of increasing risk: Class I, II, and III.

Registration process

PMDA has three regulatory pathways: pre-market submission (todokede), pre-market certification (ninsho), and pre-market approval (shonin). Pre-market submission is a notification pathway for Class I devices, in which the application is automatically approved on submission. Pre-market certification applies to Class II and III with established certification standards. Product review and QMS conformity assessment for pre-market certification is outsourced to Registered Certification Bodies (RCBs). Pre-market approval is the most rigorous pathway and applies to new Class II and III devices as well as all Class IV devices. PMDA performs the product review and QMS conformity assessment for pre-market approvals, which can include extensive clinical evidence requirements. Foreign manufacturers must also obtain Foreign Manufacturer’s Site Registration (FMR) for each manufacturing site associated with the device.

Quality management system (QMS) requirements

All manufacturers must comply with Japan’s QMS regulation, MHLW Ministerial Ordinance No. 169 (2004). Class II, III, and IV devices must obtain conformity certification to Ordinance 169, Class I devices are exempt from the certification requirement but they are still expected to maintain QMS compliance. Japan is also one of five participants in the Medical Device Single Audit Program (MDSAP). PMDA accepts MDSAP certificates for most devices, though this route may carry additional document review fees.

In-country representation

Foreign manufacturers must appoint an in-country representative with a physical address in Japan, called a Designated Marketing Authorization Holder (DMAH). The DMAH submits the registration on your behalf, but your company remains the applicant and owns the registration on approval. A DMAH is similar to MAH (Marketing Authorization Holder), except a MAH has full ownership of your PMDA registration.

Expert Support for Your PMDA Registration in Japan

Considering PMDA registration for your medical device or IVD? Our team of experts can help you strategize and coordinate market entry in Japan. Contact us to learn more about Japan registration.