Japan Extends Third-Party High-Risk Device Certification
Japan’s medical device authority has expanded its conformity assessment certification system to allow private third-party bodies to certify that certain higher-risk specially controlled devices conform to standards.
In an effort to expedite patient access to new products, the Pharmaceutical and Medical Devices Agency has accredited 12 third-party organizations to conduct the certifications, eliminating the need for the products to obtain approval from the health minister.
Previously, devicemakers could only get third-party certification for lower-risk devices, such as ultrasonic diagnostic equipment and dental alloys. The revised regulation extends the range of third-party certification to higher-risk specially controlled devices, such as pen-type insulin injectors and blood filters for heparin-coated cardiopulmonary bypass circuits, according to information the PMDA released last week.
The Japanese government carved out a new category for medical devices in a November 2013 amendment to the Pharmaceutical Affairs Law. The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices took effect a year later on Nov. 25, 2014.
Read an outline of the revision at www.fdanews.com/04-15-Japan-Revisions.pdf. — Jonathon Shacat