Another country to heavily regulates medical devices such as their design controls is Japan which falls under Japan’s Pharmaceutical and Medical Device Agency (PMDA) and works in conjunction with the Ministry of Health, Labor and Welfare to ass new product safety, development regulations and monitor post market safety. Currently all new medical device development must follow regulations laid out by the PMD Act (Introduced and forced on November 24, 2014 replacing the previous act called Pharmaceutical Affairs Law (PAL)), 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 states the following:

“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.”

The classification system in Japan differs from that of the United States or the EU. In Japan the device classification for medical devices are Class I, II, III or IV depending on their risk level. All medical devices must comply with Japanese Industrial Standards, these standards define industry-wide safety and performance requirements; similar to ISO.

Another difference compared to the U.S and EU is that all medical devices must obtain specific certification depending on what risk level the medical device falls under. For example, Third Party Certifications are needed for low risk medical devices. A Minister’s Approval on basis of PMDA review is needed for high risk medical devices. Compared to the U.S it is just between Pre-Market Approval and Pre-Market Notification 510K. For EU it is just Notified Body Certification for all medical devices. In Japan the medical device approval process follows the PMDA > Reviews against essential principles and Summary data Subsets > Reliability Review for data reliability, GLP, GCP, GMP conformity and post approval inspection.

http://www.pacificbridgemedical.com/regulation/japan-medical-device-regulations/