Industry Update: Health Canada IO (Interim Order)

mdi has been assisting clients in getting their medical devices licensed for Canada through the Health Canada offices.

Many clients are now looking to see how they can get their medical devices to market faster using the Interim Order for Health Canada. This is the information that we have come up with for using the Health Canada Interim Order:

1. A clear description of the device, including how it works, any accessories to be used with it, and diagrams/photos of the device;
2. A copy of the manufacturer’s Quality Manufacturing System Certificate, evidence of Good Manufacturing Practices, or other;
3. A discussion of whether any components are manufactured using additive manufacturing (3D printing, laser sintering, bioprinting, etc.);
4. If this device is manufactured from or incorporates animal or human tissue or their derivative, evidence of biological safety of the device;
   4.a. A summary of any bench testing data performed for the device
5. A summary of any biocompatibility testing performed with the device (if applicable)
6. A summary of the evidence of shelf-life and packaging validation testing (if applicable)
7. If the device is intended to be used at point of care or sold directly to a consumer, marketing materials for the device
8. If the device is intended to be sold in a sterile condition, a description of the sterilization method and a summary of sterilization validation testing performed
9. A list of applicable standards used in the design/manufacture of the device
10. Incidents with a discussion of each event and response from the manufacturer
11. A comparison table outlining technological differences between this device and predecessors that are or were licensed in Canada (if applicable)
12. A comparison table outlining technological differences between the proposed COVID-19 medical device and any available (authorized) comparators, to the applicant’s knowledge
13. Directions for Use
14. Attestation for Post-Market Oversight
    1. 4(1)(i) of the Interim Order requires the applicant to provide an attestation that documented procedures are in place in respect of distribution records, complaint handling, incident reporting and recalls.

15. Device Label

16. Materials
    1. 4(2)(a) of the Interim Order requires that, for Class III and IV COVID-19 medical devices, the applicant provides a description of the materials used in the manufacture and packaging of the device. Additionally, if there are any materials that are patient contacting for any period of time, biocompatibility testing of those materials may be required in order to render a decision on whether the Minister may issue an authorization.

17. Marketing History
    1. 4(2)(b) of the Interim Order requires that, for Class III and IV COVID-19 medical devices, the applicant provides a list of countries other than Canada where the device has been sold, the total number of units sold in those countries, and a summary of any reported problems with the device and any recalls of the device in those countries. This information can be provided in any format, however, summary tables are preferred.

18. Foreign Regulatory Approval
    7. 4(3) of the Interim Order stipulates that an applicant may omit the information required to be submitted in their initial application, specifically, items 4(1)(g), 4(2)(a) and 4(2)(b), if they provide evidence that their COVID-19 medical device has gained market approval by a foreign regulatory authority. This approval need not be at the National level, as Health Canada may accept approval at the State level. This evidence should include a copy of the formal approval letter issued by the authority, as well as any review summaries authored by the authority. For absolute certainty, if the Minister deems that the evidence of approval by a foreign authority is insufficient to ensure that section 5 of the Interim Order is met, the Minister may request additional information under section 9 of the Interim Order, and may also decide to issue an authorization with terms and conditions under section 7.
    8. If a foreign jurisdiction waives all pre-market submission and evaluation requirements, this would not be considered a foreign regulatory approval for the purposes of the IO.

Additionally, the client would have to certify in writing they have documented procedures in place for distribution records, complaint handling, incident reporting and recalls.

If you would like mdi’s assistance in using this IO method for getting your medical device to market faster in Canada please contact via email to:  info@mdiconsultants.com RE: Interim Order.