OBJECTIVES: With a total volume of €24 billion a year, Japan is the world’s second largest medical device market behind the US. It imports about 35% of the medical devices from abroad. Although imports have been increasing steadily over the past years, Japan still struggles to have similar access to advanced medical devices as the US and Europe. This research aimed to have a closer look at the Japanese medical device market, and further explore access barriers. METHODS: This research was conducted through in-depth secondary research and interviews with a variety of stakeholders including payers, academics, and KOLs in Japan. RESULTS: Unlike most markets where an FDA or CE mark is sufficient, medical devices in Japan require a separate in-country regulatory approval before reimbursement. Not only is this process long (approximately 2.2 years) but the requirements are much more stringent compared to the US or EU, often requiring local clinical data. This has resulted in many large med-tech companies staying away from the Japanese market. CONCLUSIONS: It is important for foreign manufacturers to understand the implications of the Japanese regulatory barriers and address them in their foreign market strategies allowing them to assess product viability early on.