Medical devices are primarily regulated in Japan by the Law on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, and Gene Therapy Products and Cosmetics. (Pharmaceutical and Medical Device Act).
A complex and difficult process is prepared for products to be placed on the market. RAPID will help you to get over that process smoothly and quickly as your marketing authorization license holder (DMAH).
We also provide support for companies seeking for overseas expansion to obtain the approval of FDA and CE markings.


Address Wide Business

RAPID supply all the services that are between your company and your client in Japan. Companies that want to export medical devices to Japan must obtain MHLW approval. Importers must comply with a set of MHLW procedures to import medical devices in Japan. Thanks to our expertise in MHLW-related fields we can work with your company to have your products approved for sale on the Japanese market.
If you have concerns that you do not know where you consult with us or you will enter the medical device industry from now on, please feel relieved to leave them to us.

Reasonable Pricing

RAPID provides free initial consulting advice.
Do you have such impression that “Regulatory affairs consulting are expensive”?
We can make a contract at an appropriate price (from 1 hour, monthly payment system and project-by-project basis) according to your company.

Our Values

RAPID will always protect client confidentiality and will always provide honest and accurate answers. We follow a policy of ethics and transparency with our clients so that they, in turn, can approach regulatory authorities with the knowledge and confidence necessary to succeed.


Total Support for Regulatory Strategy / DMAH services

RAPID provides DMAH services for companies who primarily enter the medical device industry to sell medical devices in Japan.

Regulatory Consultation
  • Applicability to medical device
  • Determine classification of medical device (class Ⅰ to class Ⅳ)
  • Necessity of clinical trial
  • Support for import customs clearance
  • Survey of product development and sterilization factory
  • Assistance with and attending meetings with the Pharmaceuticals and Medical Devices Agency (PMDA), such as Pre-application consultation meetings, and clinical study meetings.
  • Communication with the PMDA and a third party certification body
Clinical and Non-Clinical Study Consultation
  • Preparation of non-clinical study protocol
  • Implementation of safety test and non-clinical study
  • Preparation of clinical study implementation protocol
  • Preparation of clinical study report
Preparation of Application Documents
  • Preparation of application documents for approval and Summary of Technical Document (STED) and annexed documents
  • Preparation of application documents for certification and Summary of Technical Document (STED) and annexed documents
  • Preparation of notification forms of business license for manufacturer
  • Contact and negotiate with overseas manufacturer (English)
  • Consolidation of documents for GLP/GCP/GPSP compliance
  • Preparation of QMS compliance investigation application
  • Preparation answer of inquiry form to PMDA/a third party certification body
Preparation of Application Documents for Reimbursement
  • After the marketing authorization for a medical device has been granted, it is possible to apply the medical device for the reimbursement. We provide support from insurance coverage strategy planning to the application procedures.
  • Planning strategy of medical device for the reimbursement
  • Preparation of application documents for reimbursement (A1, A2, B)

Obtaining and Renewal of Business License for Manufacturers, Distributors, Importers and Authorized Representatives

Application documents shall be submitted to the relevant governor since prefectural governors are authorized to license. The license is granted by the prefectural government after being reviewed of the conformity to QMS, GVP, etc.

  • Consultation of internal system construction to QMS/ISO 13485
  • Preparation of application documents to obtain license for foreign manufacturer, distributors, Marketing Authorization Holder (MAH)
  • Preparation of documents since the license should be renewed every five years

Support for Placing Medical Device on the Market (Overseas)

RAPID provides support for procedures required to sell medical devices overseas.

  • FDA Consulting and FDA Approval 510k Submission, Premarket approval(PMA),Pre-Submissions
  • CE Marking Consulting and CE Marking Certification

In addition to the above, we will address the general business of regulatory affairs. Please feel free to contact us.


For more information about RAPID services and inquiries, please feel free contact us.

Phone +81-50-5361-6640 9:00-17:00 Japan Standard Time