The Health Pod Baker McKenzie

Japan's global strength in the medical device sector, aging population and wealth of know-how and technology make it a fascinating medical device discovery and development market. In the second installment of our Spotlight on Japan mini-series, Chris Hodgens, Ryosuke Tateishi and Wabi Tanaka — members of the Firm's Healthcare and Life Sciences Industry Group who regularly advise medical device clients on transactional as well as regulatory and compliance matters — discuss key features and practices observed in the Japanese medical device industry, including the regulatory framework and necessary approvals, supply chain characteristics and medical device pricing.

We frequently receive regulatory questions about the increasing number and variety of healthcare apps being developed in Japan and elsewhere in the world. From a regulatory point of view, the most important issue is whether a particular app will be treated as a regulated medical device under the Pharmaceutical and Medical Devices Act (PMD Act). In the first installment of our "Japan Medical Devices Law Podcast" series, Ryosuke Tateishi, our regulatory and compliance partner, Mami Ohara, an industry specialist with experience in corporate transactions, and Fei Zhou, our finance and investment specialist, take a closer look at recent developments and introduce the regulatory landscape surrounding healthcare apps in Japan.

Compliance is one of the key factors for pharmaceutical companies in running a sustainable business in Japan. In our fourth installment of the Spotlight on Japan mini-series, industry specialists Ryosuke Tateishi, Mami Ohara and Rie Kuwabara, Healthcare & Life Sciences Compliance and Regulatory counsels based in Tokyo, will take a closer look at the compliance issues in the Japanese pharmaceutical market, including enforcement trends, key compliance areas and requirements for establishing an appropriate compliance system.

Corporate virtual power purchase agreements (vPPAs) have become increasingly popular and sophisticated products as a means of achieving sustainability-related goals. In this episode, Clyde (Skip) Rankin joins David Wardell to explain what vPPAs are, how they work, and their benefits for our healthcare and life sciences clients.

Digital healthcare plays a pivotal role in the future of patient care: the pandemic has accelerated digital health reforms and provided a plethora of opportunities for healthcare and life sciences, technology and financial companies. In Asia Pacific, in particular, a rapidly expanding population, an empowered and tech-savvy middle class and limitation on healthcare resources have created the perfect conditions for digital health innovation. In this episode of the Health Pod, Elisabeth White, head of the Asia Pacific Healthcare & Life Sciences Industry Group, joins Chung Seck, a partner from our Vietnam office, to discuss the key trends, opportunities, priority areas, barriers and potential collaboration pathways from our report, Hyper-Hybridity: Defining a New Era of Digital Health Innovation in Asia Pacific.

With a strong pharmaceutical sector, an ageing population and a wealth of expertise, Japan is a fascinating drug discovery and development market. In our third installment of the Spotlight on Japan mini-series, Chris Hodgens, Real Estate Practice Group partner and industry specialist, Ryosuke Tateishi, Healthcare & Life Sciences Compliance and Regulatory Partner and Tsugihiro Okada, IP and Information Technology industry expert take a closer look at the drug development framework in Japan, including regulatory approval filing, clinical trial implementation and drug development collaboration.