Japan’s New Device Regulatory Framework Explained

AdvaMed Applauds Japan’s New Device Regulatory Framework and offers workshops to explain the new regs.


Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), recently released the following statement in conjunction with the Nov. 25 implementation date for Japan’s new Pharmaceutical and Medical Device Law (PMDL):

“AdvaMed applauds the entry into force of Japan’s medical technology law, which regulates medical devices separately from drugs for the first time. Approved by the Japanese government one year ago, the PMDL creates a framework for regulation of medical devices and diagnostics that takes into account their unique characteristics and will help improve patient access to safe and effective medical innovations in Japan – the world’s second largest market for medical technology products.

“This very significant development will have a major, positive impact on medical technology manufacturers by streamlining regulatory requirements. For example, the new law expands the scope of products eligible for third-party certification, allows quality inspections to be conducted for product groupings as opposed to individual products, and simplifies the manufacturer accreditation process.

“The device-specific regulatory framework will dovetail with Japan’s regulatory agency performance plan to facilitate timely product approvals in the country. Implemented in April, the updated performance plan has the ambitious goal of making Japan faster than the U.S. FDA in approving the most advanced category of medical devices.

“Together, these improvements will allow Japan to build on the tremendous progress it has made over the past six years in reducing review times and allowing speedier patient access to innovative, life-saving and life-enhancing treatments and cures.

“We will continue to work closely with Japan’s Ministry of Health, Labor and Welfare, and the country’s Pharmaceuticals and Medical Devices Agency, as well as our members and other stakeholders, to help ensure smooth adoption of the new law’s implementing regulations and to identify any related concerns.

“AdvaMed’s Medical Technology Learning Institute (MTLI) will be conducting workshops on the specific provisions of the new law next month in Washington D.C. (Dec. 8-9) and San Francisco (Dec. 11-12), to help manufacturers adapt to the new requirements.

“The workshops will provide an early opportunity for companies to hear directly from Japan regulatory officials about the details of the new requirements. For more information, visit www.AdvaMedMTLI.Org.”

About AdvaMed
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.

SOURCE: The Advanced Medical Technology Association

Posted in AZBio News.