Japan: Medical Devices Approval Process

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As one of the largest and most affluent aging populations in the world, Japan is an ideal market for medical device manufacturers.1 As the Japanese population lives longer, medical device manufacturers have more opportunities to take advantage of one of the largest medical device markets in the world.2 Japan is well-known, however, for being exacting in its standards and regulations, especially for foreign companies and manufacturers.  

To make things slightly easier for foreign manufacturers to market and sell their medical devices, the Japanese government put the revised Pharmaceutical Affairs Law (PAL) in effect in 2005.3 In practice, this served to open up the Japanese market, currently the second-largest medical device market in the world, and ensure the safety of medical devices in Japan.4 With this revision, the Pharmaceutical and Medical Devices Agency (PMDA), which is responsible for approving devices in association with the Ministry of Health, Labor, and Welfare (MHLW), was established.  The MHLW actively works to make the Japanese medical device market easier for foreign manufacturers to sell their devices.  In early 2009 the MHLW declared to clarify and revise the PAL for medical devices in the Mid-Term Plan of the Pharmaceuticals and Medical Device Agency.5 This commitment introduced a streamlined review process for manufacturers, with the goal of dramatically speeding up the licensing process for half of all applications by 2013.  For more information on how you can take advantage of these streamlined changes, contact us.

LNE/G-MED can help you get your medical device to the Japanese market.  Along with our Registered Certification Body partners in Japan, you can receive the benefits of local auditors and a dedicated project manager for your device.  More importantly, you will meet all the requirements to have the ability to market your devices in a high-demand market. Contact us to learn more about how to access the Japanese market.

Take advantage of the Japanese medical device market and receive this guide today!