Medical Product Registration in Japan

Registration of Medical Devices in Japan
Registration of Pharmaceuticals/Drugs in Japan

Registration of medical devices and pharmaceuticals in Japan is complicated, and high costs and long timeframes to receive approval are common. In some cases, Japanese regulators require clinical trials in Japan to be conducted, and the costs of these trials can be very high. Product registration in Japan needs to be pursued carefully and only after determining that there is a strong market demand for your product.

The regulator of medical devices and pharmaceuticals in Japan is the Pharmaceuticals and Medical Devices Agency (PMDA), which handles medical device and pharmaceutical registration. Other Japanese medical issues, such as hospitals, health insurance, and medical product registration policy, are handled by the Ministry of Health, Labor and Welfare (MHLW).

High-risk medical devices and all drugs must be approved by the PMDA (Shonin approval), while lower-risk medical devices may apply to Notified Bodies rather than the PMDA (Ninsho approval). In addition, foreign manufacturers will need accreditation from the PMDA.

Medical device and pharmaceutical registration dossier requirements in Japan are becoming more integrated with international standards from the International Conference on Harmonization (ICH) and Global Harmonization Task Force (GHTF). Still, Japanese regulators are very cautious in approving foreign medical products.

In addition to product approval and foreign manufacturer accreditation (FMA), PBM can also prepare and submit a Master File for your medical device or drug. With a Master File, you can submit detailed technical information on your product only to the PMDA for safekeeping, not to your Japanese partner or distributor. After that is complete, you can give your Japanese business partners only the Master File approval number for product registration purposes. This helps safeguard intellectual property and trade secrets.

PBM's expertise will help you navigate the Japanese regulatory system and the Pharmaceutical Affairs Law (PAL), achieve medical product registration, and access the huge Japanese medical markets. PBM will help you register your medical product in a cost-effective and timely way.

For more information on medical product registration in Japan, please see the following PBM publications and/or contact us to discuss your specific needs.

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