Major amendments to Japan’s Pharmaceutical Affairs Act of 1960 (the “Act”) will come into effect on November 25, 2014. One of the purposes of these amendments is to regulate medical devices separately from pharmaceutical products. The amendments also strengthen measures for the safety of pharmaceutical products and medical devices and establish new regulations for tissue-engineered medical products, cell-remedying medical products and gene-remedying medical products (the “Tissue-Engineered Medical Products”). The name of the Act itself will change to the Act for Ensuring Quality, Effectiveness and Safety of Pharmaceutical Products and Medical Devices.
The amendments will make, among others, the following significant changes:
Certain Class III medical devices will require only a “certification” by a third-party registered certification body instead of “approval” by the Ministry of Health, Labour and Welfare, whereas such “approvals” are now required for all Class III medical devices under the Act currently in effect (the “Current Act”); Software programs for diagnosis and treatment will now be regulated as medical devices (i.e., the current Act does not treat the software programs as medical devices); A medical device company is required to register every factory that manufactures medical devices as a Manufacturer (Seizou-gyousha in Japanese); Quality Management System (QMS) inspection of factories that manufacture medical devices will be required for every category of medical devices; Package inserts for certain pharmaceutical products, Class IV medical devices and Tissue-Engineered Medical Products shall be registered with the Minister of Health, Labour and Welfare, and the registered package inserts are required to be published on the websites of the pharmaceutical companies and/or medical device companies; and With respect to certain Tissue-Engineered Medical Products, which are newly defined under the amended Act, one will be able to obtain a temporary approval for marketing under certain conditions and time limits during which one must apply for the final approval.
Given these amendments, medical device companies operating in Japan especially will need to ensure that they obtain an appropriate certification/approval for newly developed medical devices, obtain appropriate certification/approvals for software programs for diagnosis and treatment, and register relevant factories and package inserts.