AltaQ helps manufacturers to register their products in multiple countries as a part of their commercialization plans.  Most healthcare markets require registration and approval from regulators for medical devices and IVDs.

 

Just as Europe requires compliance with EU directives (MDR and IVDR) for CE marking,  in a similar manner, in Australia TGA has at specific requirement for IVDs.  Health Canada requires registration for Medical Device License (MDEL) and a Medical Device Establishment License (MDL) and specific requirement for IVDs.   Additionally, AltaQ will work with you to register devices in multiple countries such as Turkey, Russia, China, India, Brazil, Mexico, etc.

 

Please click here to contact us to learn more about services and provide any additional information as per your needs.