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
PMDA Meetings
- preliminary general meeting (Zenpan sodan) to obtain confirmation and a guide for the subsequent meeting suitable for the issues
- premeeting (Jumbi meeting) to confirm the details of the briefing documents for Taimen meeting in advance
- primary consultation (Taimen) meeting to obtain opinion and guide for the submitted issues from the PMDA
Medical devices which have advanced feature and/or do not meet the requirements for approval/certification may require PMDA consultation meeting to obtain official opinion for the application from the PMDA. Such devices are often classified as medical devices to be approved by the PMDA and other products are considered to be certificated by a notified body.
PMDA consultation meeting is composed of three stages:
3 Stages of PMDA Consultation Meeting
Our consultants with expertise will prepare Briefing Documents (BD) for the PMDA meeting and guide you to conduct a smooth meeting by assisting and attending the meeting.
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)
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.
