Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (SOR/2022-18)

Marginal note:Application

• 3 (1) These Regulations apply to the importation and sale of a COVID-19 medical device, other than a Class I device, that is to be tested in a clinical trial, to the importation and sale of a COVID-19 drug, other than a drug that is described in Schedule C to the Act, that is to be tested in a clinical trial and to the conduct of a clinical trial in respect of such a device or drug.

• Marginal note:Non-application — COVID-19 medical device

  (2) The Medical Devices Regulations, other than sections 6 and 7 and Schedule 1, do not apply to the importation or sale of a COVID-19 medical device that is to be tested in a clinical trial or to the conduct of a clinical trial in respect of such a device if a COVID-19 medical device authorization has been issued for that device and the authorization has not been revoked in whole.

• Marginal note:Non-application — COVID-19 drug

  (3) The following regulations do not apply to the importation or sale of a COVID-19 drug that is to be tested in a clinical trial or to the conduct of a clinical trial in respect of such a drug if a COVID-19 drug authorization has been issued for that drug and the authorization has not been revoked in whole:

  • (a) the Food and Drug Regulations, other than sections A.01.022 to A.01.024, A.01.026, A.01.041, A.01.042, A.01.050, A.01.067, A.01.068, C.01.015, C.01.036, C.01.037 to C.01.040, C.01.040.2, C.01.051, C.01.064 to C.01.067, C.01.070, C.01.131, C.01.133 to C.01.136 and C.01.435 and Divisions 2 and 4 of Part C; and

  • (b) the Blood Regulations.