In Vitro Diagnostic (IVD) device commercialization in most healthcare markets requires registration and approval from regulators. Many markets have IVD approval requirements that are distinct from other types of medical devices.
Europe is one example of a market where the process of registering an IVD differs from registering a medical device. To obtain European CE Marking, manufacturers of IVD products must demonstrate compliance with the In Vitro Diagnostics Directive (IVDD 98/79/EEC).
In Australia, the TGA recognizes CE Marking for most medical devices. However, CE Marking is not accepted for IVD products as the TGA utilizes a GHTF (Global Harmonization Task Force) based classification system. Instead, you must undertake a separate IVD registration process with the Australian TGA.
Health Canada also has an IVD registration system separate from their standard medical device review process, and requires a Medical Device License (MDEL) or Medical Device Establishment License (MDL) for IVD devices depending on their classification.
How Emergo can support your IVD registration and approval
Emergo has expertise in IVD registration and approval in several major medical device markets, including in-country regulatory representation to clients. Our consulting services include:
- Determining which standards and testing requirements apply to your IVD
- Classification of your IVD according to European, Canadian, Australian or other regulatory systems
- Compiling and submitting all necessary registration documents to regulators
- Determining applicable registration fees and timelines for approval
Please contact us for more information about our IVD registration consulting services.