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.
Marketing Authorization Holder system
The amended Pharmaceutical Affairs Law (PAL), which went into effect in April 2005, has introduced a new marketing business licensing system and has changed the conventional manufacturing approval system to the new marketing approval system. Under the old system, manufacturers manufactured medical devices at their own manufacturing facilities and sold the products manufactured to wholesalers and other distributors. The new system has separated manufacturing and marketing functions so that companies are no longer required to own the facilities where devices are manufactured. Companies are required to obtain marketing approval and a marketing license for each product. To acquire a Marketing Authorization Holder license, the company must be legally registered in Japan. A Marketing Authorization Holder (MAH) license is required to obtain approval/certification for medical devices. The details are described in the Business licenses application section.
Overseas manufacturer accreditation for medical devices
Overseas manufacturers intending to manufacture drugs, quasi-drugs or medical devices overseas for export to Japan require MHLW accreditation in the same way as Japanese manufacturers are licensed.
MHLW has the authority to grant accreditation to overseas manufacturers, while PMDA examines buildings and facilities of manufacturing establishments for accreditation, which is granted to individual manufacturing establishments according to the category specified by the Enforcement Regulations.
A Japanese Marketing Authorization Holder (MAH) that markets drugs and medical devices made by overseas manufacturers can submit accreditation applications on their behalf. However, the name of the applicant on the application form should be the overseas manufacturer’s name.
Under the PAL, product approval application and product certification can be implemented under the manufacturer’s name instead of that of the distributor or subsidiary. The overseas manufacturer assigns a Japanese distributor with a MAH license as the Designated MAH (DMAH), and then puts together/submits the application for approval/certification through the DMAH.
In such cases, the overseas manufacturer owns the approval/certification, and the DMAH company works as an agent in Japan. A major advantage of this method is that the distributor can be selected/changed after regulatory approval/certification of the product.