Medical Device Registration System in Japan
Article 2 of the Japanese Pharmaceutical Affairs Law (PAL) defines medical devices as “Equipment/instruments intended for use in the diagnosis, treatment or prevention of disease in humans or animals, or intended to affect the bodily structure and functions of humans or animals.” Under this law, applicants (manufacturers and/or importers) must obtain a business licenses (referred to in Japanese as kyoka) from the relevant prefectural government, and must also acquire the status of notification (todokede), certification (ninsho) or marketing approval (shonin) from MHLW for each product. Before issuing a business licenses, the prefectural government examines an applicant’s facilities and/or personnel to determine whether the manufacturer is qualified to make or import the medical device or devices in question. Before issuing regulatory approval, MHLW examines the application file in detail with regard to the quality, efficacy and safety of the proposed medical device. The applicant is required to undergo re-examination five years after the license is initially issued.
New medical devices are also subject to re-examination after their initial regulatory approval. Medical devices with new designs, structures and principles must be re-examined after four years; those with new effects, applications or performance after three years; and orphan medical devices after seven years.
With regard to a medical device’s regulatory application, its efficacy, safety and suitability are evaluated based on scientific data available at that time. However, new medical devices must undergo follow-up evaluation regarding their efficacy, safety and suitability in the form of post-marketing surveillance (PMS). Until this PMS procedure is complete, other devices cannot be submitted as “me-too” applications.