Global harmonisation in definition and classification of IVDs
Committee:
IVD (In Vitro Diagnostics)status:
Progress
Published:
In the next revision of the Pharmaceuticals and Medical Devices Act, there will be no changes to the classification and definition of IVD under the Act. However, the importance of regulations tailored to the characteristics of IVD has been recognized, and it will continue to be a topic of discussion.
Recommendations
- EBC requests proper regulations for classification (currently classified under Pharma) and definitions/scopes, based on the special characteristics of IVDs.