Cobridge provides regulatory affairs consulting services and dossier preparation for medical device registration in Japan 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
Regulatory consultation
- Consultation for strategy on a product development for medical devices 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 with annexed documents
- Minor change notification and partial change application documents
- Notification of product’s registration for Class I medical device
- QMS compliance review application documents
- 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)
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.
