The Ministry of Health, Labor and Welfare (MHLW) and its affiliated Pharmaceuticals and Medical Devices Agency (PMDA) are responsible for the medical device registration in Japan. However, the specific responsibilities of the two authorities are different.

Medical devices in Japan are subject to regulations such as the Pharmaceuticals and Medical Devices Act (PMD Act).

Foreign manufacturers need to have a local authorized representative in Japan, and there are two types: Marketing Authorization Holder (MAH) and Designated Marketing Authorization Holder (D-MAH).

As an agent, MAH will act as license holder and be responsible for quality management system (QMS), post-market surveillance and other issues. MAH is more suitable for large enterprises, such as establishing a Japanese office.

If the manufacturer choose D-MAH as the agent, the manufacturer can hold the certificate itself, and D-MAH is only responsible for QMS, post-market surveillance, etc. D-MAH is more suitable for small and medium-sized companies.

(It should be noted that D-MAH is not applicable for products with a minimum risk level of Class I.)

Before registering a medical device product, the manufacturer also needs to complete the Foreign Manufacturer Registration (FMR), which takes about 3 months.

Japan classifies medical devices into Class I, II, III and IV based on the risk level from low to high. According to Japanese Medical Device Nomenclature (JMDN) and other standards, Class II and Class III devices can be further divided into Class II (specified controlled), Class II (highly controlled), Class III (specified controlled) and Class III (highly controlled).

For Class I products, application for registration could be directly submitted to PMDA. The authority will not review the technical documents and quality management system (QMS) of the manufacturer, but manufacturer needs to have the technical documents ready in case of inspection.

The Class II (specified controlled) and Class III (specified controlled) products with medium risk should be registered through the officially recognized third-party organization RCB (Registered Certified Body). RCB will review the technical documents, QMS, etc., and issue the certificate.

Class II (highly controlled), Class III (highly controlled) and Class IV products need to apply directly through PMDA, who will review the technical documents, QMS, etc. And MHLW will issue certificate to the manufacturer.

The Japanese QMS is based on the MHLW Ministerial Ordinance No. 169, which is similar to ISO 13485. Japan has participated in the Medical Device Single Audit Program (MDSAP), which means MDSAP certification covering the requirements of MHLW could be recognized.

The Japanese authorities’ requirements for technical documents are based on STED (Summary Technical Documentation) of IMDRF (International Medical Device Regulators Forum), and all documents should be submitted in Japanese. For high-risk, innovative products, clinical trials may need to be performed in Japan. For specific circumstances, PMDA needs to be consulted.

Registration for Class I products is relatively cheap and fast, taking only about a week. For specified controlled Class II and III products that need to register through RCB, the cost would be around US$30,000 and takes about 4-8 months. The registration of highly controlled Class II and III, and Class IV products requires PMDA review, which costs US$20,000 to US$120,000 and takes six months to three years. Specific costs and time vary according to different products. The issued product’s registration certificate will not expire, but the QMS certificate is valid for five years.

Osmunda’s global team can assist you in completing Japanese product registration and provide you with local agency services in Japan. If you want to know more about the registration of your product in Japan, please feel free to contact us.