Two Day Conference: Japan Regulatory Filing Requirements and Compliance Processes for Medical Devices (Opfikon, Switzerland – October 12-13, 2017) – Research and Markets

DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Japan - Regulatory Filing Requirements and Compliance Processes for Medical Devices" conference to their offering.


- Japan's classification system differs from that of the United States or European Union

- Medical devices are classified to Class I, II, III, or IV depending on their risk level

- Medical devices must also comply with Japanese Industrial Standards and these standards define industry-wide safety and performance requirements

- Strict new package insert requirements

- Change to MAH Licensing rules

- A new MAH License category for In Vitro Diagnostic (IVD) devices

- A new registration system for manufacturers

- A new QMS conformity assessment system

- New formats for pre-market certification and pre-market approval applications

- Expanded scope of third party certifications

- Rules for software as a medical device

- Rules for transferring pre-market certifications

- And Much More...

Why Should You Attend:

- Understand the entire Registration and Approval Process in Japan

- Identify and understand the Major Changes to Medical Device Registration Process in Japan

- Streamline the medical device registration process so that you can obtain approval for your product in the most cost-effective and timely manner

- Participants will discuss their own device registration and approval process relative to their work-related responsibilities and handling submissions

- Review and discuss pain points, challenges and solutions

For more information about this conference visit


Research and Markets
Laura Wood, Senior Manager
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
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U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices