Case Study 32 : Registration of Class III Medical Devices (Software) with PMDA in Japan

Company Situation

The Client is a Canadian based Medical Devices company, that had registered its device in Canada and was seeking to register the same in Japan as the next strategic market. Since the Client did not have presence in Japan and no prior experience with PMDA, Client selected GRP as a partner to help it succeed in Japan.

GRP Solution

GRP has successfully obtained approval 50+ medical devices of different classes in Asia for its clients including in Japan. These devices range from low risk to high risk class III devices for various applications. GRP supported Client right from planning stage but putting forward a roadmap for Japan and potential challenges with possible remediation.

GRP identified Client’s device would be classified as Class III with PMDA as neurosurgical navigation unit where as per the definition by PMDA, ‘a device provides spatial positioning information about apparatus used during neurosurgery, neurosurgery/orthopedic surgery, and other types of surgery. Once strategy for Japan was defined, GRP executed end to end registration strategy as a partner for Client in Japan.

Want to be updated on the Latest Regulatory Information

Follow GRP on Social Media !

More Resources:

Aerial view of Tokyo cityscape with Fuji mountain in Japan, Tokyo

Japan's PMDA

In Japan, The Pharmaceuticals and Medical Devices Agency (PMDA) is the government organization in charge of reviewing drugs and medical devices, overseeing post-market safety, and providing relief for adverse health effects. The PMDA operates under the Ministry of Health, Labor, and Welfare (MHLW) .These two government organization both handle a wide range of activities, from approval reviews to post-market surveillance.