Japan Medical Devices Regulatory Environment
Japan has been taking steps to improve the regulatory environment and to expedite the review process for medical devices. The Pharmaceutical and Medical Devices Law (PMD Law), which includes the establishment of a device-specific regulatory framework now has a three-step execution process.
The first phase of implementation is scheduled to take effect on September 1, 2020 and covers the codification of the Sakigake designation system and the Conditional Early Approval system, which have been administered as pilot programs under the Ministry of Health, Labor and Welfare (MHLW). The Sakigake designation scheme is the Japanese version of the U.S. FDA’s Breakthrough Therapy (BT) designation which aims to accelerate the time to market for innovative products.
The Conditional Early Approval is a system to accelerate the time to market for highly needed medical products where it is difficult to conduct clinical trials due to small patient populations. In addition, a device-specific approval system to promote early introduction of continuously improved medical device will be introduced. Under this system, regulatory hurdles such as the need for partial change applications will be reduce in order to keep pace with changes arising from artificial intelligence (AI) and other technological innovations and to realize rapid patient access to such medical devices. The second phase, which will take place on August 1, 2021, enhances compliance systems for licensed manufacturers, including a fine system for false and misleading ads. The final step, which will take place on December 1, 2022, will impose barcode labeling on packaging of drugs and medical devices, and also improve traceability of regenerative medicine products.
Due to the favorable regulatory environment and other reasons such as a fast aging demographic profile with relatively prosperous seniors holding increasing expectations for improved quality of life in their later years, the demand for advanced medical technologies is expected to increase. BMI Research estimated that Japan’s medical device market will exhibit a CAGR of 4.5% in yen terms from 2018 to 2023. According to the latest official figures from the MHLW Annual Pharmaceutical Production Statistics, the Japanese market for medical devices and materials in 2018 was approximately $26.2 billion (USD 1 / Yen 110.40).
Advanced medical devices that alleviate pain, complement lost functions, and improve the quality of life should show steady growth in demand. Also, in-home care devices, technologies and Health IT related products are expected to grow as the number of people in out-patient care increases. Artificial intelligence (AI) assisted medical devices such as diagnostic imaging or treatment support will see increased market opportunities. Due to stronger consumer health concerns, other promising growth areas include self-care and preventive care medical devices and products.
For more information, please contact office.tokyo@trade.gov, and refer to the Medical Device sector.