Japan's House of Representatives is expected to pass the new law for ensuring the quality, effectiveness and safety of medicines, Medical Devices and so on this year. Compared to its predecessor the Pharmaceutical Affairs Law (PAL) the new law will bring far-reaching changes for all stakeholders in the certification process. Specifically, the law will introduce significantly stricter requirements for the quality management systems (QMS) of manufacturers and their marketing authorisation holders (MAHs). One of the key changes is that in the future, some class III "specially controlled Medical Devices" will no longer be certified by the Pharmaceuticals and Medical Devices Agency (PMDA), but by registered certification bodies (RCBs) such as TÜV SÜD Japan.
The new law at a glance
In a first step, foreign manufacturers must list facilities and look for Japanese partners to take over the role of MAHs with liability for the Medical Devices they distribute in Japan. Both foreign manufacturers and MAHs will face stricter requirements regarding their quality management systems in the future. In accordance with the new law, MAHs will have to provide evidence that they have established a QMS before they are issued with a market authorization.
Approval of Medical Devices is based on risk classification similar to those of the United States and the EU. Class I Medical Devices only need to be registered with the PMDA by the MAH ("Todokede" – pre-market submission). Devices in class II that are classified as "controlled Medical Devices" must be certified by an RCB ("Ninsho" – pre-market certification). The new law will transfer the certification of so-called "me too" Medical Devices in class III, which so far have been the responsibility of the PMDA, to the RCBs. As in the past, innovative Medical Devices in class III which are considered "specially controlled Medical Devices" and Medical Devices in class IV will require pre-market approval by the PMDA ("Shonin" – pre-market approval).
Objectives and impacts of the revised law
By revising its Pharmaceutical Affairs Law, Japan's Ministry of Health, Labour and Welfare pursues several objectives. While the old PAL targeted medicinal products, i.e. pharmaceuticals, the new law also specifically addresses Medical Devices and in-vitro diagnostic Medical Devices. With respect to new market trends, the law has now also considered regenerative medical techniques’ products and stand-alone medical software for the first time. In addition, steps were taken to ensure global harmonisation of Japan's national system.
However, one of the most significant new features of the revised law is the certification of class III "me too" Medical Devices by the RCBs. It is expected to speed up registration processes, ensuring faster availability of innovative technologies for patients and noticeably reducing the time to market for manufacturers, since PMDA’s workload will be shared by several RCBs. After the bill is passed by Japan's House of Representatives which is expected to happen this year, it will come into effect within one year.