This intensive, day-and-a-half workshop will help attendees gain knowledge about Japan’s revised Pharmaceutical and Medical Devices Law and its impact on medical device companies in Japan; learn about the extensive new regulations that Japan is adopting to implement the provisions in the law; and understand how the new regulations will affect the data and information required in submissions and in the post-market process. The new law takes effect on November 25, and a large number of implementing regulations are being released just prior to that date. This workshop offers a unique opportunity to learn about these new regulations directly from key officials at Japan’s regulatory agencies so that companies can learn what adjustments they need to make. The scope of the program will cover medical devices and IVDs, excluding drugs.

Regulatory Affairs and R&D officers at the operational and management levels who support product registration in Japan, as well as Quality Affairs and Operation officers who are involved in QMS audits at a source plant, will benefit from this workshop.

Speakers for this program will be officials from Japan\’s Ministry of Health, Labor, and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA).