Regulatory Developments in Japan’s Medical Devices Market

Watch our recorded webinar to find out about the recent changes to Japan’s Pharmaceutical Affairs Law and how this will impact on your business in the Japanese medical devices market.

UKTI Japan’s Life Sciences Team are delighted to announce their 1st webinar this year. They have invited a speaker from Japan’s leading CRO and regulatory consulting company, CMIC Co., Ltd. on Tuesday 27th January 2015, 09:30am (UK time) to explain about recent changes in medical devices regulations in Japan.

Major amendments to Japan’s Pharmaceutical Affairs Law came into effect on 25 November 2014.

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One of the purposes of these amendments is to separate regulations on medical devices from pharmaceutical products and also create new regulations for regenerative medicines.

In this webinar, Ms. Fukuko Arai, Manager of Medical Devices Consulting Group, CMIC Co., Ltd., will talk about the latest developments on Japan’s regulations and application procedures for medical devices. She will also explain about the overview of  CMIC’s business and how CMIC will be able to support UK companies entry to the Japanese medical devices market. (Regulations on regenerative medicines will not be covered on this occasion.)

About CMIC Co., Ltd

CMIC Group started contract business of pharmaceutical development as Japan’s first CRO in 1992. The outsourcing of pharmaceutical development had not yet taken hold in Japan at that time. However, CROs were recognised as “partners of pharmaceutical companies in R&D” after the implementation of new GCP guidelines in 1997. CMIC developed the market in Japan as a pioneer of CRO.

Today CMIC Group is building an organisational structure beyond the boundaries of CRO in order to respond quickly and flexibly to diverse needs.

The company offers comprehensive support for the pharmaceutical and medical device company’s value chains that consist of pharmaceutical and medical device research and development, manufacturing and sales. By creating synergies through stronger cooperation among their business units, CMIC aims to become a service provider that contributes to maximizing customer value.

CMIC pursues high-level quality in all of the services, as they continue undertaking challenges that earn them long-lasting trust as a partner of their customers.

About the Speaker 

Ms. Fukuko Arai, Certified Business Management Consultant, Manager, Medical Devices Consulting Group, Medical Devices Division, CMIC Co., Ltd

Ms. Fukuko Arai is a medical device regulatory consultant who works at CMIC Co., Ltd. as manager of the medical device consulting group.
She has BS and MBA degrees in the physiological sciences. She is also a certified business management consultant.

She has more than 20 years’ experience in medical field including consulting medical device company regulatory submission, drug regulatory submission, business license submission, marketing and sales.

Benefits of Watching

This webinar will explain:

  • Recent regulatory developments on medical devices in Japan.
  • How CMIC will be able to support UK medical devices companies with smooth and effective entry to the Japanese medical devices market.

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This webinar was recorded on 27 January 2015.

CMIC Group Overview

Regulatory Developments in Japan’s Medical Devices Market Presentation Slides