Registration Environment in Japan
The Japan registration system is unique and complicated. Terms such as drug lag or device lag that are used in the field refer to the lengthy duration required to obtain approval in Japan in comparison with other countries. Many devices that have been approved and are widely used in other countries have not yet been approved in Japan, and in some cases, only devices from two or three device-generations ago are available. To combat this situation, the MHLW (Ministry of Health, Labour and Welfare) implemented a major revision of the PAL (Pharmaceutical Affairs Law) in 2005 and reformed the approval and licensing system. Despite the system remaining in a period of transition and some initial confusion, the change has improved the efficiency of reviewing by delegating the review and certification processes to an outside body (i.e., a registered certification body) for many widely used devices such as endoscopes and ultrasound diagnostic systems. This delegation conforms to the certification guidelines made on the basis of international standards.
The business license system has also been revised, and a new accreditation system for foreign manufacturers as well as a MAH (Marketing Approval Holder) system have been adopted. For a foreign company to enter the Japanese market, it is essential to develop a regulatory strategy based on a good understanding of its duties as a foreign manufacturer as well as the options available and the advantages/disadvantages of each.
Japan MDC is a government-licensed firm as a MAH; we provide a full range of specialized regulatory assistance for Medical Devices involving closed communication with its clients and with the authorities; this reflects the high value we place on communication to achieve faster approval.
Obtaining regulatory approval is not the final goal; rather, it is the beginning of a business strategy process. Our wealth of experience with a variety of medical products and technologies enables us to create strategic approaches with sincerity and passion that allow clients to achieve their goals in introducing medical devices to the Japanese market.
