Regulatory Focus™ > News Articles > Japan Launches Implantable Device Post-Marketing Project

Japan Launches Implantable Device Post-Marketing Project

Posted 20 November 2012 | By Louise Zornoza

Japan's Pharmaceutical and Medical Device Agency (PMDA) has launched J-MACS (Japanese Registry for Mechanically Assisted Circulatory Support), a data-collection project on the post-marketing experience with ventricular assist devices (VAD).

The system, said regulators, is intended to be the first step in developing a new national system for collecting and evaluating data on the post-marketing experience with implantable medical devices.

The project is a collaborative effort between the PMDA, academic societies such as the Japanese Association for Clinical Ventricular Assist Systems and the Japanese Society for Cardiovascular Surgery, hospitals and industry.  Hospitals will report on their experiences with the devices, and those hospitals that do not join the project risk losing national medical insurance coverage for implantable VADs. Companies will be required to report medical device malfunctions to the registry and conduct follow-up investigations. 

Patient enrollment in J-MACS began in June 2010. To-date, some 18 sites are registered, with close to 140 patients enrolled.

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