Conducting Clinical Investigations In Canada

Clinical Investigations pathway in Canada is determined by the classification of your device. Obviously the higher the classification the more you will require and the more safety precautions you will need for the investigation.

In general, Class I devices can proceed to investigational testing without applying to the Health Canada for approval. Nevertheless Records for investigation testing of Class I devices need to be kept by the "seller" as per Section 81 of the regulations. All other classified devices II, III and IV must have TPD approval prior to commencing the investigation.

For additional information you can go the Health Canada's website:

http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/test_md3_im3_e.html

For In-Vitro Diagnostic Devices IVDD, the manufacturer should refer to the specific Health Canada Guidance: "Preparation of an Application for Investigational Testing - in Vitro Diagnostic Devices"

http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/test_iv3_e.html

Requirements for Safety and Effectiveness

Sections 10 to 20 of the Medical Devices Regulation set out the requirements for ALL medical devices sold in Canada. To apply for an authorization to conduct investigational testing on human subjects in Canada, a manufacturer and/or device sponsor must use the application form in Appendix 1 of the document "Preparation of an Application for Investigational Testing - Medical Devices". Following review of the application and provided that the testing can be conducted without seriously endangering the lives of patients, users or other personnel, the minister may grant an authorization.

Other factors that go into the decision process include:

the testing is not contrary to the best interests of the patients and
the objective of the testing is achievable
investigational testing conforms to the principles of the Declaration of Helsinki and the Medical Research Council's "Code of Ethical Conduct for Research Involving Humans - May 1997."

The format for the submission is straight forward and is clearly stated in Health Canada's guidance document (for format see Appendix 2 of: "Preparation of an Application for Investigational Testing - Medical Devices")

Although Health Canada allows you to structure your application in a way that is suited for your investigation they highly recommends providing the following with your application.

an executive summary
table of contents
discrete chapters appropriate for each class of medical device

If you do plan to deviate from their recommended format it is advised to ask ahead for their permission.

Applications are accepted in either French or English.

A positive review on an application will result in a green light to proceed. The approval is conditional provided that no changes occur to the protocol, identity of the qualified investigations, the institution as well as the type of diagnosis or treatment for which the device is sold. Any changes to any one of these criteria will require that you resubmit additional information BEFORE actually making the changes.

Denied Approvals

Clinical Investigations are usually denied in cases where the device cannot be used safely during the testing. Other reasons include situations where the investigational testing is not in the best interest of the patients or if the objective of the testing cannot be achieved.

In all cases - Health Canada does allow the manufacturer the right to appeal the decision.

Confidentiality of Applications

Health Canada keeps all information submitted as part of the application in strict confidentiality. This is their policy regarding pre and post authorization. Hence you can be assured that all trade secrets, scientific, technical as well as commercial or financial information is kept confidential.

Device Labeling

As part of the application for investigational testing in Canada, the manufacturer (or device sponsor) must submit a copy of the device labeling. This includes product monograph and all advertising brochures intended to be used with the device.

In Particular, Health Canada will also want to see the labeling that will be given to the qualified inspector and/or the patient. It is important per Subsections 86(c) and 86(d) that the following statements "Investigational Device" and "To be Used by Qualified Investigators Only" and "Instrument de recherche" and "Réservé uniquement à l'usage de chercheurs compétents" be present in BOTH English and French. This is important whether or not the testing is conducted in Quebec or not. Health Canada want to see both set's of warnings.

Note: In the case of investigational testing of IVDD Subsection 86(e) requires the

Statement (again in both English and French): "The performance specifications of this product have not been established" and "Les spécifications de rendement de l'instrument n'ont pas été établies"

For Class III and IV investigational testing written approval from each proposed institution's Research Ethics Board must be provided with the application. A provisional investigational testing authorization may be granted by Health Canada conditional on the receipt of a Research Ethics Board approval. In such cases testing must not begin until the Ethics Board approval has been given.

In circumstances where the institution lacks a Research Ethics Board, an Ethics Committee conforming with the Medical Research Council Guideline on the "Code of Ethical Conduct for Research Involving Humans." Must be convened. A guideline on how to set up this comittee is available on the MRC website at http://www.cihr-irsc.gc.ca or by contacting the MRC at Holland Cross, Tower B, 5th Floor, 1600 Scott Street, Postal Locator 3105A, Ottawa, Ontario K1A 0W9.

In conclusion, products undergoing investigational testing in Canada must follow specific Health Canada requirements and guidance. For Class II and higher devices, the manufacturer must obtain Health Canada's approval before commencing any testing on humans. For Class III and IV devices, the manufacturer or device sponsor is also required to obtain the institution's Research Ethics Board review and approval.

Specific questions or concerns they are urged to contact the Manager, Device Evaluation Division, Medical Devices Bureau at (613) 954-0297.