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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