Japan's medical device market is one of the most robust markets in Asia, but its regulatory system can be confusing. Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process. In this presentation, Ann Marie Boullie, Vice President of Business Development for EMERGO, will discuss some of the most complex aspects of the Japanese registration process, including:
- JMDN codes: device classification and predicates
- Clinical data requirements and PMDA pre-submission meetings
- Registration routes (Todokede, Ninsho, Shonin)
- QMS (Ordinance 169) requirements
- Role of the Marketing Authorization Holder (MAH)
- Plus more ...
Free white paper: Overview of Japan's Pharmaceutical and Medical Devices Act
In November 2014, Japan’s Pharmaceutical Affairs Law (PAL) covering medical device registration requirements was replaced by the Pharmaceutical and Medical Device Act, or PMD Act. The PMD Act made significant updates to registration requirements and the approval process for foreign medical device manufacturers. In this white paper, we discuss how to register a medical device for sale in Japan as a foreign company and requirements to be aware of.
Free white paper: Japan's New QMS Conformity Assessment System
The Pharmaceutical and Medical Device Act (PMD Act) made significant changes to the country's medical device registration process. It also changed the way manufacturers meet quality management system requirements. While Japan's quality regulations are similar to ISO 13485, there are some important differences you should be aware of if you want to sell your medical device in Japan.