Japan’s New Device Regulations – Faster Than FDA

Japan is beginning to implement a new device regulatory scheme that it hopes beats the FDA in review times and makes it easier for device makers to commercialize their products in the country.

Separates Devices From Drugs

AdvaMed President and CEO Stephen Ubl applauded the new law which regulates medical devices separately from drugs for the first time. “Approved by the Japanese government one year ago, the Pharmaceutical and Medical Device Law (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.”

Before the new law was implemented manufacturers had to go through a highly complex and lengthy registration process.

“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, ” said Ubl.

Accelerated Approval Process

According to the Emergo Group, there is also an accelerated approval process for medical devices, especially for those the government thinks are important for public health.

Over the next four years, according to Emergo, “the PMDA (Pharmaceuticals and Medical Devices Agency) will pursue quality improvements of PMDA application reviews via enhanced training of regulatory staff, more effective consultation with applicants and more standardized evaluations of applications.”

Regulators also want to speed up the time it takes to evaluate devices. By 2018, they intend to set standard evaluation periods for all types of PMDA applications, including:

• New Devices – 12 months for normal and 9 months for priority review
• Improved – 7 months with clinical data and 9 months without
• Generic Medical Devices – 5 months for new approvals and 4 months for partial changes

Third-Party Certification

To reach these review goals, the PMDA intends to move toward third-party rather than governmental certification for some Class III devices. They plan to hold public-private meetings to evaluate whether they are meeting those goals and see if additional steps should be adopted.

Ubl: Faster Than FDA

Ubl added that the new 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.”