In November 2014, Japan's Pharmaceutical and Medical Device Act (PMD Act) replaced the Pharmaceutical Affairs Law (PAL) covering medical device registration requirements.
The new law brought significant changes to Japan's already complicated regulatory system. In this white paper produced by Emergo's office in Tokyo, we answer your biggest questions about new 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 ISO 13485 compare to the Japanese QMS regulation?
- How is the new QMS regulation configured?
You will learn all this and more in this 8-page white paper.
About the Author:
Michiharu Miayara is President & CEO of Emergo's office in Japan.
Medical Device Approval Process in Japan
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