Japan's regulators push for quicker device approval process

Japan's regulators may speed up the approval process for some generic medical devices, a big development in one of the world's largest markets for healthcare products and services.

The Yomiuri Shimbun newspaper reports that Japan's Health, Labor and Welfare Ministry proposes a bill that would change the law, in part, to allow 60% of Class III medical devices--such as kidney dialysis machines and generic dental implants--to be submitted for approval through private accreditation organizations rather than the Pharmaceutical and Medical Devices Agency (PMDA), an approval body supervised by the health ministry.

That would be a big advance over the current situation. Right now, private accreditation organizations handle approvals for Class II devices (low-to-moderate risk), including MRI and ultrasound machines and electronic endoscopes. But Japanese regulators mandate both Class IV devices (pacemakers, heart valves, stents) and Class III moderate- to high-risk devices (ventilators, kidney dialysis machines, artificial bones) go through the PMDA. And the process can last about 5 months, the story explains.

Considering how Japan is one of the world's largest markets for healthcare products and services, the proposed regulatory change will likely be closely watched by the industry. The United States is an even bigger market and insiders have long clamored for a quicker approval process here. The FDA in November asserted it has became quicker, too, reducing the average time it takes for a PMA approval by about one-third of its 2010 high, and also shortening the average time it takes for 510(k) clearances.

- read the full story

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