Supporting your Regulatory Application from the viewpoint of the regulatory professionals

We offer the consulting service of the Regulatory application strategy from the start of the development of the medical devices, supporting to create internal Quality Manual, prepare the documents of approval application and other services as MAH. Not only Japanese staffs, but there are also staffs from overseas like China and Taiwan. In addition to the support for Japanese medical device companies for the domestic Regulatory application and expansion of the business to overseas, we also offer our support for oversea companies to enter into Japanese medical device market.

MAH (Marketing Authorization Holder) / DMAH (Designated Marketing Authorization Holder) service

DMAH (Designated Marketing Approval Holder) service
Supporting the oversea medical device companies to expand their business to Japan

In Japan, all the medical device companies are required to conduct Quality Management based on QMS and Post Market Safety Management based on GVP. The oversea medical device companies that don’t have their office in Japan, need to be the Foreign exceptional approval (certification) applicant according to the Foreign exceptional approval (certification) system and able to keep their approval/certification. And if it is the case, they need to designate the MAH (Marketing Authorization Holder) within Japan.

As DMAH, our company performs our mission as your representative for the overseas medical device companies

Consultation

  • Support for Clinical Development Strategy and Planning
  • Support for planning entry into Japanese medical device market
  • Consultation related to the application

Preparation of Application for Medical Devices

  • Preparation of Application for Marketing Approval/Certification
  • Health Insurance Reimbursement Application
  • Making internal Quality Manual
  • Preparation of Documents for Japan QMS（Quality Management System）
  • DMAH (Designated Marketing Approval Holder) service

Business Expansion in Asia

  • Support for the entry to Japanese medical device market from China, Taiwan and Korea
  • Support for Clinical Studies in Japan
  • Support for Regulatory application and Post Market procedure in Japan
  • Coordination with CRO in Asian site
  • Consulting concerning Clinical development ・Regulatory application in Asia