Medical Devices Regulations

68.17 The Minister shall refuse to amend an authorization for a medical device if the effect of the proposed amendment would be that the device would not be authorized in relation to at least one of the following medical conditions:

• (a) a medical condition that qualified the device as a UPHN medical device when the application for the authorization was submitted under section 68.11;

• (b) a medical condition in relation to which the device was authorized when the application to amend the authorization was submitted under section 68.14, in the case where

  • (i) the holder of the authorization previously submitted an application to amend the authorization under section 68.14 to have the device authorized in relation to the medical condition,

  • (ii) the medical condition qualified the device as a UPHN medical device when that previous application was submitted, and

  • (iii) the authorization was amended under section 68.15 on the basis of that previous application;

• (c) a medical condition in relation to which the device was not authorized when the application to amend the authorization was submitted under section 68.14, in the case where

  • (i) the holder of the authorization submitted the application to have the device authorized in relation to the medical condition, and

  • (ii) the medical condition qualified the device as a UPHN medical device when the application was submitted.