As a manufacturer of in vitro diagnostics, you should familiarize yourself with the regulatory requirements and country-specific specifics at an early stage to ensure a successful market entry. Invest in a well thought-out plan and thus avoid unpleasant surprises when it comes to the approval of your products.Don't waste valuable time, talk to our regulatory affairs experts in good time. We will make sure that your IVD will be approved in the respective target country at the announced time.Reserve a no-obligation initial consultation now to put our expertise to the test.
Different countries, different customs – this applies all the more to certification and market entry. Use our expertise and you are on the safe side!
Worldwide market access for IVD: Helpful questions to speed up your RA process
- Are there country-specific differences in the definition of an in vitro diagnostic product? And are the classifications of the products comparable in the different countries?
- Which data collected in Europe are recognized in other markets?
- What additional information, data or documents must be provided on a country-specific basis?
- What is the structure of the technical documentation? Is the STED (Summary Technical Documentation) format suitable?
- How long are the product certificates valid?
- What has to be considered in case of product changes?
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