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.
- 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