New Japanese Regulations Go Into Effect on November 25, 2014

There are many new changes in the Japanese medical device regulations. These changes will become effective on November 25, 2014. Some of the changes include:

  1. The name of the Pharmaceutical Affairs Law (PAL) will be changed to the — Act on Securing Quality Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy products, Gene Therapy Products, and Cosmetics. The new act will be abbreviated as the “PMDA Act”.
  2. All Class 2 and some Class 3 devices will be approved by certification bodies rather than the PMDA. To date, certification bodies have only been used for some Class 2 devices.
  3. The Quality Management System (QMS) process will be revised, and the current accreditation will be changed to registration. In short, building and facilities conformity was a prerequisite for accreditation, but will not be a prerequisite for registration. In addition, QMS inspections will be conducted according to product groups.
  4. Software as a standalone medical device will now be regulated in Japan. Before the new regulation, software was included in the device approval. Going forward, software as a standalone item can be registered in Japan. However, the details of the standalone software registration requirements are still unclear.