In November 2014, Japan introduced the Pharmaceutical and Medical Device Act (PMD Act), which 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.
In this white paper produced by Emergo's office in Tokyo, we answer your biggest questions about QMS requirements in Japan, including:
- Who is an applicant for QMS Conformity Assessment?
- What is the new manufacturer registration system?
- What is the registration scope of Medical Devices and IVDs?
- Who is exempt from QMS conformity assessment
- How does transition to ISO 13485:2016 affect QMS compliance in Japan?
Learn all this and more in this 8-page white paper.
About the Author:
Michiharu Miyahara is President & CEO of Emergo Japan. Mr. Miyahara has more than 15 years of experience with quality assurance and regulatory issues facing medical device manufacturers selling in and outside of Japan. He previously served as the Director of the Regulatory Affairs and Quality Assurance Advisory Service Group at KPMG in Tokyo, a consulting division he started within the company in 1995.
Medical Device Approval Process in Japan
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