Japan 2022: Medical Device Regulatory Update

RAC Credits
Virtual Programs Virtual Programs
Wednesday, 16 February 2022 (11:00 AM) - Wednesday, 16 February 2022 (12:30 PM) Eastern Time (US & Canada)

With a market size of about $30 billion, Japan is the third largest medical device market in the world, however, it is not an easy market to enter.

Learn strategies for determining the best regulatory path for your product and investigating market access in this 90-minute live webcast. The presentation will help you better determine the best regulatory registration and reimbursement strategies, required steps, and documentation needed to enter the Japanese medical device market. The program will also cover:

  • Japanese clinical trials
  • DMAH/MAH third party registration
  • SaMD
  • Sakigate
  • The importance of Japanese KOLs
  • A case study on reimbursement

Registration Fees & Deadlines

4 January 2022 - 19 January 2022: Member $150.00 | Nonmember $175.00

20 January 2022 - 16 February 2022: Member $175.00 | Nonmember $200.00

Learning Objectives 

This virtual program will answer questions including:

  • How do you classify your device in Japan?
  • When and how can you consult with the PMDA?
  • What are the registration routes?
  • What documents are required for product registration, Foreign Manufacturer Registration (FMR), and Quality Management Systems (QMS)?
  • How does Japan evaluate SaMD?
  • How is reimbursement determined?
  • What strategies can be employed to increase reimbursement?
  • What factors should be considered for Japan entry?


Ames Gross

Ames Gross is the president and founder of Pacific Bridge Medical (www.pacificbridgemedical.com). He founded PBM in 1988 and has been helping medical device companies with regulatory and business issues in Japan and Asia over the last 34 years. Gross has given a number of presentations at RAPS events and has written for Regulatory Focus on Asian regulations and regulatory topics. He graduated from the University of Pennsylvania and has an MBA from Columbia University.

Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

All cancellation requests must be submitted in writing to raps@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone. 

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the workshop.


Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org  

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