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Health Canada submissions for medical devices

In Canada most medical devices are imported. In addition, the Canadian market shows a dynamic growth and is therefore becoming more and more important. We at novineon support you on the way to the approval of your medical device in Canada.

Since 2019, you as a medical device manufacturer must have a MDSAP certificate (Medical Device Single Audit Program) if you want to maintain or apply for medical device licenses in Canada.

Health Canada issues two types of licenses for medical devices: The Medical Device License (MDL) and the Medical Device Establishment License (MDEL). For Class I medical devices, an MDEL must be applied for. If your medical device is classified as Class II, III or IV, you must apply for an MDL from Health Canada. This is a product-specific approval with a procedure similar to the 510(k) procedure of the US FDA.

Our services:

  • Product classification
  • Planning of the submission, e.g. gap analysis with regard to necessary tests
  • Creation and submission of MDL submission
  • Communication with Health Canada during the entire process and subsequent submission of information and documents during the review process


Contact your novineon specialist.

Phone: +49 7071 98979 – 147