Cobridge provides consulting services and dossier preparation for product-registration services for medical devices and biologic products from a strong footing in science-based regulatory strategic thinking.
We understand the transition of dossiers for products brought to market first overseas and then to Japan, and have experience in the preparation of Japanese registration documents from North American and European dossiers. We examine a product’s existing preclinical and clinical data to design a regulatory strategy for the best path to Japanese MHLW or PMDA approval or certification from third party certification body.
Since the amendments to the Pharmaceutical Affairs Law went into effect in 2005, foreign manufacturers outside of Japan need to designate a Japanese Designated Marketing Authorization Holder (DMAH) or MAH in order to sell medical products in Japan. For more information, please refer to our DMAH services.
Services provided by Cobridge
- Consultation for strategy on a product development for medical devices and IVDs in Japan
- Gap analysis for regulatory requirements, whether foreign clinical study data is usable for a Japanese product application
- Reviewing, assessing and organizing supplied documents and information, providing consultation for necessary information for product registration in Japan
- Assistance for addressing queries from the PMDA or a third party certification body
Preparation of dossiers
- Preparation of an application documents for medical devices
- Approval (Certification) application and STED and annexed documents
- Notification of sales and manufacturing
- QMS compliance review application
- Application for foreign manufacturer accreditation/registration
- Preparation of application documents and Quality Overall Summary (QOS) for Drug Master File (DMF) (Click here for ICC services)
- Preparation of application for Orphan Drug Designation
- Preparation of application documents for reimbursement
Communication and Negotiation
- Communication with the PMDA and a third party certification body
- Assistance with and attending meetings with the MHLW and/or the PMDA, such as Pre-application consultation meetings, and clinical study and GCP compliance review meetings.
Assistance for addressing queries from health authorities or third party certification bodies after application
- Cobridge provides consultation services to assist addressing queries from the PMDA or a third party certification body about an applications and STEDs including those prepared by the client.