Medical devices policy
© Bogdan Hoda |

Here, we look at medical devices policy of Japan’s Ministry of Health, Labour and Welfare. The Ministry now has Katsunobu Katō in place, who very recently replaced Nemoto Takumi as the Minister of Health, Labour and Welfare in the country

Nemoto Takumi (1) served as the Minister of Health, Labour and Welfare from 2nd October 2018 until 11 September 2019. Katsunobu (2) Katō is currently in this role (3,4). In this article, we will briefly examine one key policy of Japan’s Ministry of Health, Labour and Welfare (MHLW), that concerns pharmaceuticals and medical devices.

Pharmaceuticals and medical devices

On pharmaceuticals and medical devices, we know that MHLW put together the “Strategy of SAKIGAKE” by a project team at the Ministry to lead the world in the practical application of innovative medical products. This team plans strategies from basic research to the practical applications along with related divisions within the MHLW. SAKIGAKE also covers approval reviews, insurance coverage, improvement of infrastructure and the environment for corporate activities, safety measures, as well as global expansion. SAKIGAKE can be summarised as follows:

SAKIGAKE Designation System: Promoting research and development in the country aimed at early practical application for medical devices, innovative pharmaceutical products and regenerative medicines.

Scheme for Rapid Authorization of Unapproved Drugs: This aspect concerns accelerating the practical application of unapproved/off-label use of drugs for serious and life-threatening diseases to include use in Western countries if it satisfies certain conditions. Improving the environment for companies to undertake the development of such drugs is, therefore, vital in this vein. (5)

It is fitting that we now take a look at the “International Pharmaceutical Regulatory Harmonization Strategy – Regulatory Science Initiative” of the MHLW. In essence, this strategy clarifies Japan’s policy priorities in the pharmaceutical and medical device sectors, for example, to more effectively promote international harmoisation and cooperation initiatives under the direction of the Minister of Health, Labour and Welfare, who as from September 2019 is Katsunobu Katō and before that, Nemoto Takumi.

It is also worth noting here that this strategy aims to show Japan’s proactive leadership in the region of Asia and throughout the global community. Policies within this include setting up the “Asian Pharmaceuticals and Medical Devices Regulatory Training Center” within the Pharmaceuticals and Medical Devices Agency (PMDA) (6) to promote pharmaceutical regulations in Japan by regulatory authority officials in Asia. (7)

On the subject of harmonisation, Yasuhiro Fujiwara, MD, PhD, Chief Executive of the PMDA looks to the organisation playing an active role in discussions concerning international harmonisation of regulations and he wants to raise standards at Asian and other regulatory authorities. “Without being bound by precedents, the PMDA will proactively pursue new initiatives and contribute to the advancement of the public health and safety of all people in Japan,” he added. (8)

In August this year, the Medical Equipment Examination Management Division within MHLW approved the target items of the “remanufacturing” system for single-use medical devices, for the first time. We know that MHLW collects used single-use medical devices under the responsibility of medical device manufacturers and distributors, for example. In 2017, the Ministry established laws and regulations to create a system for replacement, reassembly, sterilisation, so that medical devices can be used again. (9)

As Katsunobu Katō is now the Minister of Health, Labour and Welfare in Japan, we wish him well in his recently acquired position as he pushes forward a wide array of policy issues of which pharmaceuticals and medical devices are just a very small part.













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