This case concerns our work on a Japanese medical device manufacturer's pancreatic duct stent, including preparing submission documents, organizing the evaluation approach and coordinating with a domestic distributor. The product we supported obtained marketing approval.
Client: Japanese medical device manufacturer
Support provided: Preparation of approval submission materials, evaluation planning and stakeholder coordination
Outcome: Marketing approval obtained
Organizing the Use of Existing Materials and Additional Testing
In preparing the submission, we determined how much of the available information, including biological safety data, could be used and what additional performance evaluation was needed. Instead of assuming all information had to be newly obtained, we considered the use of existing materials separately from additional evaluation, and checked samples and drawings for testing with the manufacturer.
Preparing Submission Materials With the Manufacturer
We prepared the application and package insert in coordination with the manufacturer, with responsibilities divided between us. We checked information needed to prepare the submission materials and coordinated with the manufacturer's staff on matters including the content shown in the product drawings.
The domestic distributor's regulatory and quality assurance staff were also involved. We addressed questions about responsibilities for preparing the documents and the need for testing, and continued submission preparations after sharing the scope of the manufacturer's work and our own.
Marketing Approval Obtained
The pancreatic duct stent we supported obtained marketing approval. This case involved a series of regulatory support activities, from organizing an evaluation approach based on the product and available materials to preparing submission materials and coordinating with stakeholders.
Related Services
・Approval, certification and notification support
・Development and regulatory support for GI endoscopy and biliopancreatic devices
Discuss Regulatory Submissions for Biliopancreatic Devices
Contact us if you need help preparing submission materials or organizing how existing data would be used and what additional evaluation was needed. We will review the product and available information to consider the work required and our scope of support.
Company and product names are withheld. This case describes the support provided for this product. It does not guarantee that the same submission approach will apply to other products or that approval will be obtained.
Prepared by: MK Consulting Co., Ltd.