Yoshio Mitsumori05.06.06
Under previous regulation, the business license had been divided into three categories: manufacturing, import and sales. The latest PAL introduced a new license, “Marketing Authorization Holder” (MAH), which pertains to the roles of QA, safety and post-market safety that formerly fell under the old manufacturing and Import license categories. The MAH is classified as Type I, II or III, depending on the product, and its requirements vary according to associated risks. The MAH must distinguish the qualified general controller, QA controller and safety controller and also must organize compliance programs for Good Quality Practice and Good Vigilance Practice. Its scope of responsibilities is extremely extensive.
Every license holder, including MAH, must be a Japanese entity and needs to be evaluated for its credibility as a medical device supplier; however, under the new PAL, foreign manufacturers also need to be accredited, factory by factory, by a Japanese authority, whose task is to ensure that they are compliant with Japanese Good Manufacturing Practice requirements (which are similar to ISO 13485:2003, with some variations). This accreditation usually is conducted through review of documentation, but sometimes on-site audits are conducted as well.
The required information for accreditation includes a list of medical devices being manufactured; plant layout and major equipment; a biography of the plant manager and his or her self-declaration of eligibility; a certificate issued by the local government or authority; and so on. The accreditation is good for five years and must be renewed at the time of expiration.
It should be noted, however, that most foreign manufacturers—whose products were already approved under the old PAL—have been grandfathered into the new system and are exempt from this accreditation until their Japanese partner’s time comes to renew its MAH license. At this point, many manufacturers wonder who is responsible for submitting the new application. In general, the associated MAH submits an application to authorities on behalf of the foreign manufacturer.
One problem that can arise pertains to the accreditation of an OEM’s sterilization service provider that has no direct contact with Japanese MAHs. In this case, it can be unclear as to who will initiate action, who will pay and when the accreditation will be completed. Sometimes, an associated MAH may voluntarily submit an application on the service provider’s behalf. Another alternative is to go through an independent party who would work on the company’s behalf as an agent.