Medical Device Registration Process in Japan

Medical Device Registration Process in Japan

Japan stands as the world’s second-biggest medical device market, after the US. The Japanese medical device market is expected to reach from $54.5 billion in 2018 to $74.7 billion in 2025, growing at a compound annual growth rate (CAGR) of 4.6% according to GlobalData, The MHLW has taken several steps to improve the process for medical device market approval in Japan.

Top reasons to choose Japan as your medical device market

  • The rapidly aging Japanese population,
  • An increasing number of patients with chronic and lifestyle diseases,
  • Universal health insurance coverage, and
  • Regulatory measures are assumed to drive the Japanese medical device market.

The Japanese government has taken new initiatives to streamline the regulatory approval review process and accelerate the launch of innovative medical products.

The Ministry of Health, Labor, and Welfare (MHLW) has taken several steps and made to improve the transparency of the approval review system to accomplish a quick review process, which is equivalent to, or faster than that of North American and European markets.

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In order to register your medical device in Japan, you need to answers the following.

  • What are the regulations and laws governing the registration of medical devices in Japan?
  • What are various classes of medical devices?
  • How you would classify your medical device?
  • What are the requirements for registering your medical device in Japan?
  • What is the process to register each class of medical device?
  • Timelines and costs involved in registering various classes of medical devices?
  • How can a foreign manufacturer register your medical device in Japan?
  • What is the additional layer to be followed by foreign manufacturers?
  • How to import the approved medical device in Japan?

Get Details on Regulatory, Requirements, and Process for Registering Medical Device in Japan.

Credevo has prepared this report by collecting the relevant information as per the current understanding and awareness of Credevo. Click on the blue button below to download the report.

Note: The details presented in the report are intended to help in creating awareness about the regulatory process and requirements for registering your medical device in Japan. While the report can be considered as an informative resource, it is not being presented as legal guidance, a binding document, or any authoritative report. The information in this report was prepared on the basis of relevant information from the public domain as of the date, however, the regulations and requirements may change with time and it is advisable to refer to current regulations at any given time. It is recommended to confirm the specific details, requirements, and processes applicable to your specific products at a given time before initiating any process of medical device registration.