Medical Product Registration in Japan

Registration of Medical Devices in Japan
Registration of Pharmaceuticals/Drugs in Japan
API Drug Master File Submissions in Japan

The experts at Pacific Bridge Medical (PBM) can help you unpack the complexities of medical product registration 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.

Read on to learn more about the regulatory bodies that govern medical device registration and drug registration in Japan.

Japan Medical Device Regulations Agencies

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.

The Japanese government encourages foreign drug manufacturers to register their API documents involving manufacturing and quality methods directly to the PMDA through the Drug Master File (DMF) sytem. This system allows foreign companies to protect their confidential information.

Medical Device and Drug Master File Submission in Japan

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 Helps You Navigate Japan's Drug and Medical Device Regulations

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.

Contact PBM Today

Do you need help with medical product registration in Japan? Contact PBM today for a free consultation with our pharma and medical device regulatory consultants.

Need more information? View the PBM publications listed below to learn more about Japanese regulations for drugs and medical devices.

Click here for a free 15 minute consultation from Pacific Bridge Medical

Go from Medical Product Registration in Japan to the main Product Registration page

Go back to the homepage

Get Sourcing/Manufacturing in Asia Consulting

Back to Top