AdvaMed Praises Launch of Japan’s Device Regulations

U.S. devicemakers welcomed the launch of new medtech regulations in Japan, saying they will work with the country’s health ministry and the Pharmaceutical and Medical Devices Agency to ensure a smooth transition.

The law, which was adopted by the national legislature last year, creates a unique regulatory framework for devices and in vitro diagnostics and is expected to improve access to novel technologies.

Stephen Ubl, president and CEO of AdvaMed, says the law will have a positive impact on manufacturers by streamlining regulatory requirements, expanding the range of products eligible for third-party certification, and allowing quality audits to be conducted for product groupings, rather than on a product-by-product basis. It also simplifies the accreditation process for manufacturers, Ubl says.

The law goes hand in hand with the April implementation of a PMDA performance plan to speed product approvals. The goal, according to Ubl, is to approve devices faster than the FDA.

AdvaMed is planning two workshops — Dec. 8-9 in Washington, D.C. and Dec. 11-12 in San Francisco — to help manufacturers adapt to the new requirements. — Kellen Owings

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