Registration requirements
Medical Device Licensing for class II, III and IV
Medical devices classified as class II, III and IV must be reviewed and licensed by Health Canada before they can be sold on the market place. The submission complexity is dependent on the device class with submissions for class IV devices being the most complex.
Atinza supports clients in term of application and review process to ensure that client’s submissions are properly prepared to avoid delays due to Health Canada’s requests for additional information.
We also support various license amendment due to device related changes, labeling changes, changes to the name of licensed devices and others.
Atinza can support clients to review label and classify your products into Class I to IV
We can prepare and submit Applications for Class II, III or IV
Medical Device Establishment Licenses (MDEL)
Atinza will assist with preparation and filing of a Medical Device Establishment License (MDEL) application.