Working group: Authorization and registration
The Approval and Registration Working Group deals with the latest national regulations governing the approval and registration of IVD products worldwide. The new requirements are collected, discussed and, if necessary, commented on by the members on a quarterly basis.
In addition to the country lists, the working group also discusses lists that include the expected time required for registration and approval, the requirements for product changes and the consideration of CE marking for in-vitro diagnostics (IVDs) worldwide. Every two years, the WG organizes a seminar that covers the basics of approval and registration and provides an overview of current focus countries.
Objectives of the WG:
- To monitor and interpret the publications of new or amended registration regulations worldwide
- To create a forum for the exchange of information on problems that arise
- To develop common positions
- To enable a uniform approach to German authorities
- To contribute a German position to the MedTech Europe umbrella organization
- To influence EU legislation
In addition to the main focus, the working group enables its members to exchange information about similar challenges in third countries.

Dr. Sascha Wettmarshausen
Regulatory Affairs & Quality, Deputy Managing Director
wettmarshausen@ vdgh.de