Introduction of Medical Device Grouping Tool
Grouping of multiple medical devices for product registration can help reduce number of applications required to be submitted thus reducing the cost and effort. The Medical Devices Branch (MDB) has introduced a new self-help tool to guide in grouping of medical devices for purposes of premarket registration. This medical device grouping tool will help determine the grouping category that is most appropriate for your medical devices when submitting a product registration application. This grouping tool is an addition to the existing compendium of Medical device registration and licensing self-help tools which have been developed to assist our stakeholders and facilitate the registration process for medical devices.
We encourage you to actively use our various self-help tools, as we continue to enhance the website to deliver better user and service experience to our stakeholders. Please send us your feedback using the prescribed feedback form.