Nuclear Substances and Radiation Devices Regulations (SOR/2000-207)

12. (1) The Commission or a designated officer authorized under paragraph 37(2)(a) of the Act may certify a model of a radiation device after receiving an application that includes the following information:

• (a) the applicant’s name and business address;

• (b) the name and business address of the manufacturer of the device;

• (c) the brand name and model number of the device;

• (d) the design of the device and its components, including any standards used in the design;

• (e) the intended use of the device;

• (f) the name, quantity in becquerels and form of the nuclear substance to be incorporated into the device;

• (g) the method of incorporating the nuclear substance into the device;

• (h) the expected radiation dose rates around the device in all modes of operation, including the method, calculations and measurements used to establish them;

• (i) instructions for the use, transportation and storage of the device;

• (j) instructions for conducting leak tests on the device;

• (k) instructions for dealing with accidents, including fires and spills, in which the device may be involved;

• (l) a description of the labelling of the device;

• (m) the quality assurance program that was followed during the design of the device and that will be followed during production of the device; and

• (n) the recommended inspection and servicing program for the device.

• (o) [Repealed, SOR/2008-119, s. 28]

(2) The Commission or the designated officer may request any other information that is necessary to enable the Commission or the designated officer to determine whether the model of the device poses an unreasonable risk to the environment, the health and safety of persons or national security and whether certification of the model of the device would be in conformity with measures of control and international obligations to which Canada has agreed.

13. (1) The Commission or a designated officer authorized under paragraph 37(2)(a) of the Act shall notify a person who has applied for the certification of a model of a radiation device of a proposed decision not to certify the model, as well as the basis for the proposed decision, at least 30 days before refusing to certify it.

(2) The notice shall include a description of the person’s right to be provided with an opportunity to be heard in accordance with the procedure referred to in section 15.

14. (1) The Commission or a designated officer authorized under paragraph 37(2)(a) of the Act shall notify a person to whom a certificate for a model of a radiation device has been issued, and any licensee who is licensed in respect of that model, of a proposed decision to decertify the model, as well as the basis for the proposed decision, at least 30 days before decertifying it.

(2) The notice shall include a description of the person’s and the licensee’s right to be provided with an opportunity to be heard in accordance with the procedure referred to in section 15.