Manufacturing and sales of medical devices

Medical devices approved (certified) by the MHLW (RCB) must be sold into the Japanese market by a MAH*1 who is responsible for quality control and post-market safety control.
If foreign manufacturer does not have license of a MAH, it must choose to distribute a medical device from following below:

  • Obtained a license of MAH
  • Commission to a MAH

Foreign Special Approval System (FSAS) and Designated Marketing Authorization Holder (DMAH)

When a foreign manufacturer to be exported a medical device to Japan appoint MAH and apricate MHLW( or RCB) it, MHLW( or RCB) may grant special approval of it .
Through this system, foreign manufacturers have the following benefits:

  • Approval (certification) can be held by itself.
  • Focus on sales

It is possible to obtain a license of MAH at the Japan branch.

What is DMAH?

The marketing authorization holders is required to perform the following tasks.

  • DMAH*2 conformities with ministerial ordinances on QMS*3 and GVP*4 on behalf of foreign manufacturers who have obtained a special foreign approval (certification).
  • DMAH takes measures to prevent the occurrence of hazards in health and hygiene caused by the medical devices pertaining to such approval.

  1. MAH:Marketing Authorization Holder ↩︎
  2. DMAH:Designated Marketing Authorization Holder ↩︎
  3. QMS:Quality Management System ↩︎
  4. GVP:Good Vigilance Practices ↩︎

Schematic diagram of DMAH

  

Outline of Designated Marketing Authorization Service

  • Cooperation in manufacturing control and quality control.
  • Post-marketing safety control.
  • Representation and management of regulatory application, etc.

  

Please contact us for more information.