- Feb 27, 2011
Here is the reply I got from Health Canada regarding OEM components and laser "kits"
Health Canada’s Consumer and Clinical Radiation Protection Bureau (CCRPB) is responsible for the regulation of radiation emitting devices under the Radiation Emitting Devices (RED) Act. Anyone who chooses to modify and sell a radiation emitting device is also subject to the RED Act.
As per Section 2 of the RED Act respecting definitions,
2. In this Act,
"radiation emitting device" means
(a) any device that is capable of producing and emitting radiation, and
(b) any component of or accessory to a device described in paragraph (a).
Although there are no specific regulations regarding OEM components for portable lasers, these products fall under the definition of a radiation emitting device and must therefore meet the general provisions, Sections 4 and 5 of the RED Act respecting prohibition and deception:
4. Except as authorized by regulations made under paragraph 13(1)(c), no person shall sell, lease or import into Canada a radiation emitting device if the device
(a) does not comply with the standards, if any, prescribed under paragraph 13(1)(b) and applicable thereto; or
(b) creates a risk to any person of genetic or personal injury, impairment of health or death from radiation by reason of the fact that it
(i) does not perform according to the performance characteristics claimed for it,
(ii) does not accomplish its claimed purpose, or
(iii) emits radiation that is not necessary in order for it to accomplish its claimed purpose.
5. (1) No person shall label, package or advertise a radiation emitting device in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its design, construction, performance, intended use, character, value, composition, merit or safety.
(2) Subsection (1) applies only in relation to representations relating to the emission of radiation.
(3) No person shall fail to comply with the regulations respecting the labelling, packaging or advertising of radiation emitting devices.
CCRPB does not provide pre-market assessment (i.e. testing) or certification of compliance for these products. Under the RED Act, it is incumbent upon the manufacturer, importer or distributor to ensure that their product complies with applicable requirements prior to sale, lease or import into Canada.