Guidance for laser products: Scope of the regulations
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Regulated parties
These regulations apply to laser products sold, leased or imported into Canada. A person who manufactures, imports, or distributes any quantity of laser products (regulated party) is subject to these regulations.
A laser product brought into Canada (for use, lease, processing, re-export, service, or other purpose) is considered importation.
Distributing a laser product includes selling or leasing/renting the product to one or more persons, even if there is no money or other consideration exchanged.
Note that the regulations apply to a laser product if it is sold, leased or imported into Canada on or after October 9, 2025. If a person intends to resell or lease/rent out a previously existing/stocked laser product, they must make any modification(s) necessary to ensure it is compliant with the regulations.
In scope products
The regulations concern the sale, lease or import of a broad range of laser products in Canada. These include consumer, commercial, industrial, pest management, defence and research applications.
The following products are in scope, which means they are subject to the regulations:
- laser product prototypes
- for example, a one-of-a-kind design to be imported into Canada, sold or leased for any purpose
- laser components that are the final product, which means the design and operation are final and ready for an intended application
- for example, a kit or collection of components to be assembled by the end-user that will result in a functioning laser product
- laser repair parts that are intended to be reintegrated into a final product and do not need a tool to emit laser radiation
- for example, if a replacement laser part is removable and capable of operation by simply plugging into an electrical mains, inserting a battery or charging via a USB cable
- laser products that may or may not have an energy source (for example, a battery power pack, or charging cable) at the time of sale, lease or import
- laser products that are offered for second-hand sale or leased/rented out
- laser products that are modified or refurbished to be imported into Canada, sold or leased
- meaning the laser product’s accessible laser radiation is altered after manufacture (for example, if collimating optics are introduced or an interlock feature is disabled)
- a regulated party that changes a laser product's original performance or intended functions must ensure it:
- is reclassified correctly
- has appropriate engineering features
- bears redesigned labels (both IEC standard and product identification and origins) and
- is accompanied by revised user information
- if a laser product is modified, incorrect labels must be removed or covered by correct labels
- lasers that are designed to function as conventional lamps
- for example, image projectors, spotlights, warehouse lighting, stadium spotlights, headlamps and flashlights containing an enclosed laser system
- For details, refer to Classification and engineering requirements
- medical laser products that do not require a medical device licence or authorization, which includes
- Class I medical devices
- must also meet applicable requirements of the Food and Drugs Act and the Medical Devices Regulations
- for example, a walking cane with a laser-aiming feature
- for more information:
- refer to the Guidance on medical device establishment licensing or
- email the Medical Devices Directorate at meddevices-instrumentsmed@hc-sc.gc.ca
- medical devices imported for personal use
- must also meet applicable requirements of the Food and Drugs Act
- examples:
- a hair removal laser intended for direct contact with the skin and purchased for personal use outside Canada
- a therapeutic laser purchased online and imported for personal use
- medical devices intended for use on animals
- must meet the regulations to mitigate any potential laser radiation hazards
- must also meet the general requirements of the Food and Drugs Act
- for example, a laser-based system to relieve pain or heal wounds in pets or livestock
- Class I medical devices
- laser products with low accessible emission levels
- For details, refer to Classification and engineering requirements.
Out of scope products
The following products are out of scope, which means they are exempt from the regulations:
- laser products that require a medical device licence or authorization under the Medical Devices Regulations
- for example, Class II, III and IV medical devices that contain a laser such as computed tomography (CT) scanners with aiming beams, radiotherapy positioning systems and laser-based respiratory gating systems for medical imaging
- refer to the definitions under the Food and Drugs Act and to the Medical Devices Regulations
- for more information, consult the web page on medical devices or email the Medical Devices Directorate at meddevices-instrumentsmed@hc-sc.gc.ca
- laser products that are considered laser components according to the IEC standard
- this means a laser that meets the criteria outlined in the fourth paragraph of Clause 1 in the IEC 60825-1:2014 standard. All four of these criteria must be met to allow this exemption from the regulations:
- the laser must be sold to another manufacturer
- the laser must be used as a component of another system (integrated therein)
- the integrated laser system must be intended for subsequent sale and
- the laser component must remain inoperable if removed from the final product
- for example, a laser diode module that's sold to a manufacturer for integration into a final product for subsequent sale and requires a tool to operate when removed from the system for which it is intended
- when Health Canada assesses laser components, we will look for information indicating that the four criteria outlined above are met. For example:
- a statement that it is solely intended for use as a component of a final laser product and remains inoperable when removed from the system for which it is intended;
- an accompanying notice that the final laser product manufacturer purchasing the component(s) will supply instructions for safe installation.
- If one or more of these four criteria are not met, the laser is not exempt from the regulations. For example:
- an optical module that is sold to someone who is not a manufacturer (such as when it is offered directly to the end user)
- a laser part that is not used as a component or integrated into another system
- there is no subsequent sale after the laser product is complete/ready-to-use (such as a laser part intended for building into a final product and used in-house but never for sale) or
- the original part can be made to function or operate (that is, emit laser radiation) without the use of a tool when removed from the final product
- this means a laser that meets the criteria outlined in the fourth paragraph of Clause 1 in the IEC 60825-1:2014 standard. All four of these criteria must be met to allow this exemption from the regulations:
- laser repair parts consistent with the IEC standard
- for example, a replacement laser that's inoperable until installed into a final product (as intended)
- devices that cannot be made to produce or amplify laser radiation
- for example, light-emitting diodes (LEDs) produce light that is divergent (spreads out in multiple directions) primarily by the process of spontaneous emission
- for example, super-luminescent diodes generate a bright and broad spectrum of light by amplifying spontaneous emissions
- a laser-based system incorporated into a vehicle within the meaning of the Motor Vehicles Safety Act
- for example, laser illuminated headlights, laser sensors for adaptive cruise control and autonomous driving, as well as laser-based systems for head-up displays in road vehicles
- for more information, email Transport Canada at mvs-sa@tc.gc.ca
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