Japan’s Pharmaceutical and Medical Device Agency (PMDA) is the regulatory body responsible for reviewing drug and medical device applications. The PMDA works in conjunction with the Ministry of Health, Labor, and Welfare to assess new product safety, develop comprehensive regulations, and monitor post-market safety. Current Japan medical device regulations are laid out in the PMD Act, also known as the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics. The PMD Act affects all aspects of Japanese device registration including in-country representation, certification processes, licensing, quality assurance systems, and in-country representation. The PMD Act came into force on November 25, 2014 and replaced the Pharmaceutical Affairs Law (PAL). Key features of Japan’s current regulations include:
- Some Class III medical devices are able to undergo third party certification.
- Medical software programs are independently regulated.
- Manufacturers are required to be registered rather than be licensed.
- Quality management systems (QMS) are streamlined. QMS inspection is conducted on the Marketing Authorization Holder and is conducted per product family, not on individual products.
Regenerative Medical Products
Japan’s current PMD Act also contains extensive information about Regenerative Medical Products. According to the PMDA, Regenerative Medical Products are defined as processed human cells that are intended to be used for:
- The reconstruction, repair, or formation of structures or functions of the human body
- The treatment or prevention of human diseases
- Gene therapy
The PMD Act has significantly shortened the phased clinical trial period so that Regenerative Medical Products can be used on a conditional authorization basis in a much timelier manner.
Japan’s classification system differs from that of the United States or European Union. Under the Japan medical device regulations, medical devices are classified to Class I, II, III, or IV depending on their risk level. Medical devices must also comply with Japanese Industrial Standards. These standards define industry-wide safety and performance requirements.
Manufacturing sites that are located outside of Japan must obtain manufacturer’s registration from the PMDA if the site is involved in any of the following processes:
- Design and development
- Design and development of in-vitro diagnostic reagents
- Production or sterilization of medical devices
Manufacturers that are based outside of Japan must appoint a Marketing Authorization Holder to be their representative. The Marketing Authorization Holder acts as the legally responsible party for the medical device. The manufacturer and the Marketing Authorization Holder work together to ensure that all products meet Japan’s Quality Management Systems rules and regulation.
For more detailed information about product registration and regulatory requirements for medical devices in Japan, please see Medical Device Registration in Japan.
Japan Medical Device Regulatory Resources
Japan Medical Device Regulatory Webcast
For the most comprehensive and in-depth overview of the Japanese medical device regulations, view the Japan Medical Device Regulations Updates and Recent Revisions Webcast. Key topics include regulatory updates, PMDA consultations, device classification, Japanese GCP, product reimbursement, how to expedite product registration and maximize the use of foreign clinical data, and more.
Medical Device Regulatory News from Japan
Pacific Bridge Medical releases timely news briefs on medical device regulatory affairs in Asia every month. Click here to view the latest updates on Japan medical device regulations.