Nuclear Substances, Radiation Devices and Class II Equipment and Facilities

CNSC covers both licensing and compliance for:

• Class II Nuclear Facilities and Prescribed Equipment
• Nuclear Substances and Radiation Devices

The licensing process for nuclear substances, radiation devices and Class II prescribed equipment and facilities is based on what CNSC refers to as a “use type”.

Among the examples of use types regulated at CNSC are:

• diagnostic and therapeutic nuclear medicine
• industrial radiography
• fixed and portable gauges
• laboratory studies
• x-ray fluorescence
• brachytherapy, teletherapy and certain irradiators

Important Information

Consult Regulatory Instrument Index by Regulation or by area of application and safety area.

Risk-informed regulatory program

CNSC has established a risk-informed regulatory program based on transparency, integration of effort, and a more comprehensive risk-informed approach to licensing and compliance. The overall objective was that all facilities would be ranked relative to the risk they posed. The regulatory effort from a licensing and compliance perspective would then be based on the ranking.

The varying levels of risks posed by each use type have shown it is unnecessary to undertake all the steps listed above for every risk groups.

Although all use types require an assessment prior to the issuance of a licence, not all licensees require the same level of compliance verification. Whereas a high-risk use type may undergo Type I inspections, followed by Type II inspections, then submit an ACR, a low risk use type may only be required to submit the ACR.

The general idea of the risk-informed regulatory program is that the use types deemed to be of high or medium risk are subject to a higher degree of regulatory control, including more frequent and in-depth inspection, and other activities to verify compliance with CNSC regulations and licence conditions.

The components of the risk-informed program include assessment and compliance activities.

Assessment process

The assessment process is usually done as an office review, and may include:

• the review of a licence application (new application or renewal of an existing licence)
• the review of a radiation protection program, or
• the review of an amendment request

Compliance process

As part of the risk ranking exercise, compliance expectations were developed to form the basis of the regulatory plan for each facility, which has a unique risk profile. The compliance process is divided into 3 components:

1. Type II inspection

A Type II inspection is an on-site snapshot of the licensee’s operations. A list of non-compliances is normally given on-site, with a final report being sent to the licensee at a later date.

2. Type I

A Type I inspection is commonly referred to as an audit. It consists of an on-site, in-depth, planned review of specific programs. Several CNSC staff members may participate, and they may be on-site for a period of several days. This type of inspection will include staff interviews, observations of work activities, and comprehensive procedure and record reviews.

3. Annual Compliance Report (ACR)

The third component of the compliance process is the annual compliance report (ACR). It is meant to be a brief overview of the licensee activities in the previous year. The submission of an ACR is a condition of the licence.

New Web site content

CNSC is currently updating its regulatory framework to draw upon international standards and best practices and to meet the growing demand for nuclear technologies. New Web content will be added to provide convenient access to information intended to assist you with your regulatory information needs.

If you have suggestions for specific content that would be helpful to you and other licensees, send your comments to licensees@cnsc-ccsn.gc.ca

Need more information?

If you need more information, please contact CNSC:

Telephone: 613-995-5894 or 1-800-668-5284 (Canada only)
Fax: 613-992-2915
Email: licensees@cnsc-ccsn.gc.ca