The most important requirements for the successful market entry of your IVD are the regulatory strategy as well as your quality management system (QMS).Despite the fact that harmonization efforts are already taking place worldwide, manufacturers of in vitro diagnostics still need to familiarize themselves intensively with the approval details of the respective countries; costs and time-to-market of IVDs are also important factors that should be taken into account in your considerations.Our Regulatory Affairs and IVD team will provide you with detailed advice on country-specific approval requirements, support you in implementing the requirements, and provide contact with your official bodies (e.g. BfArm or FDA) - for successful approval on the estimated time.
Regulatory requirements for the marketing of in vitro diagnostic products in different countries.
Many things need to be considered when approving an in vitro diagnostic product internationally, including:
- Country-specific requirements for product approval and registration,
- various requirements for QM systems,
- different economic operators - importers/traders/manufacturers/EU representatives - with various tasks and obligations.
Smart registration strategy: how to reach your target market
Each country has:
- Each country has:their own authorities, Notified Bodies and national authorities in the EU (e.g. the BfArm in Germany) or, for example, the Food and Drug Administration (FDA) in the USA, or the National Medical Products Administration (NMPA) in China;
- Various regulations; e.g. the IVDR and MDR (EU), FD&C Act (USA) or Order 650 in China;
- different QM requirements, e.g. EN ISO 13485 in Europe (meanwhile also accepted by other countries) or the 21 CFR 820 Quality System Regulation in the USA.
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