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Japan Eases Approval Process for Select Medical Devices

October 5, 2010 – 9:35 am

It is going to get a little easier for device manufacturers to introduce certain products into the Japanese marketplace. Japan’s Ministry of Health, Labour and Welfare (MHLW) has modified the classification of some medical devices, paving the way for acceleration of an approval process that is typically long and arduous.

On 27 September, the MHLW issued Ministerial Ordinance No. 354, which moved an additional 120 medical devices into the Class II Specified Controlled Devices category. These devices can be registered with the MHLW through the premarket certification process using a registered certification body (RCB).

More than half of Class II devices now can be cleared for market using the less-burdensome premarket certification process. There are 1788 Class II medical devices, of which 1036 are now classified as Specified Controlled Devices. The remaining Class II devices continue to be subject to premarket approval, which means that applicants need to go through the government-related Pharmaceuticals and Medical Devices Agency (PMDA). But that may be changing, as well.

“The MHLV is planning to issue premarket certification standards for all Class II devices by the end of 2011, so more shifts are to follow,” says Michiharu Miyahara, President and CEO of international medical device consultancy Emergo Japan. “The move shows that the PMDA is working to resolve device lag. Getting certifications from a private RCB is a lot faster than obtaining approvals from the government.”

The premarket certification process is similar to the CE marking path to market. Foreign manufacturers must be certified to ISO 13485, however, to show that they meet Japan’s QMS (Ministerial Ordinance No. 169). Several European notified bodies operate in Japan as authorised RCBs.