Specialized services in regulatory consulting for medical devices
Japan MDC (JMDC) was founded by Mr. Kunihiko Mitsuda and Ms. Nobuko Matsunaga in July 2003 as a government-licensed firm with Marketing Authorization Holder (MAH)/Designated Marketing Authorization Holder (DMAH) status focusing on marketing and regulatory consulting with specialization in medical devices. Many medical companies choose JMDC as their in-country regulatory representative thanks to its provision of a full range of specialized regulatory assistance services for medical devices and its close communication with clients and the relevant authorities. JMDC places high value on communication to achieve faster approval.
For non-Japanese medical device manufacturers, the biggest challenges to entering the Japanese market are the language barrier and the complexity of the registration system; the Japanese government’s Ministry of Health, Labour and Welfare (MHLW) and its Pharmaceuticals and Medical Devices Agency -Japan’s review body for medical products (PMDA) division accept only Japanese-language documentation. JMDC aims to guide clients surely and effectively through the registration process and to provide assistance in securing medical device approval and certification.
Obtaining regulatory approval is just part of an overall marketing strategy process rather than being the final goal in itself. The considerable experience of JMDC supports the development of strategic approaches that allow clients to achieve their greater goal of introducing medical devices to the Japanese market.
JMDC staffs have been served as an official member of the organizations listed below.
1. WG7 Task Force on Consultation System Utilization
MHLW(Ministry of Health, Labour and Welfare), PMDA (the Pharmaceuticals and Medical Devices Agency) and organizations related to the medical device industry have established nine working groups to achieve accelerated review for approvals. WG7 is one of these groups, and is tasked with discussing the details, system and quality of PMDA consultation with a view to implementing related improvements.
2. Education WG
JFMDA(Japan Federation of Medical Devices Association) organizes the education WG, where educational seminars have been planned and executed in cooperation with the authority and relative industrial groups.
3. EBC Regulatory Affairs Committee
JMDC serves on the Medical Equipment Committee of the European Business Council in Japan (EBC), and also works as a member of the EBC Medical Device Regulatory Affairs sub-committee.
4. Educational Seminars SIG
Educational Seminars SIG periodically organizes regulatory seminars for the medical device industry in cooperation with MHLW, PMDA and the WG Task Forces.