Given your company's plans to enter the Japanese market and previous export experience, we will skip the details on export qualifications.

To market their products in Japan, medical device companies must comply with Japan's Pharmaceutical and Medical Device Act (PMD Act). However, language barriers and complex certification processes pose challenges in the registration of medical devices in Japan.

Under the PMD Act, the TOROKU registration system requires domestic manufacturers to register factory information with the government-authorized local authority, including product design, production, and key process information. Foreign manufacturers must register their manufacturing information with the PMDA (Pharmaceuticals and Medical Devices Agency).

Process for PMDA Registration:

1.1 Preparation Stage. Determine the product classification (Class I, Special Control Class II, Class II, Class III, Class IV) and product JMDN code, select a Japanese Marketing Authorization Holder (MAH).

1.2 The manufacturer registers the factory with PMDA.

1.3 Class II Special Control products apply for QMS factory inspection with the authorized certification body PCB, while other Class II products, Class III, and Class IV products apply for QMS factory inspection with PMDA and obtain the QMS certificate.

1.4 Apply for the Pre-Market Approval certificate. Class II Special Control is certified by PCB, and other Class II products, Class III, and Class IV are certified by MHLW (Ministry of Health, Labour and Welfare).

1.5 Pay the application fees.

1.6 Revise registration documents, and get registration approval.

1.7 All categories of products require the MAH to notify and register with RBHW (Regulatory Bureau of Health and Welfare) for import notification before they can be imported and sold.