Licences for medical procedures involving ionising radiation

Submit the completed application form and necessary documentation to the Swedish Radiation Safety Authority at registrator@ssm.se.

The necessary documentation includes:

• A register extract: A register extract showing that your organisation is registered in the Health and Social Care Inspectorate’s (IVO’s) Healthcare Provider Register.
• Description of the procedures: An adequate description is required to understand which procedures the licence will cover and to assess whether these are justified.
• Organisation, control and management: A description of the organisation performing procedures involving ionising radiation, including the division of responsibilities, authorities and cooperation for tasks of significance to radiation safety.
• Premises and equipment: Registration of radioactive sources and premises, as well as an account of how the premises are designed to limit exposure to ionising radiation.
• Training: An account of how staff are trained in radiation protection, and to handle equipment and apply methodology.
• Patient protection: Procedures for assessing whether the procedure is justified, guidelines for referrals to diagnostic examinations and optimisation routines.
• Staff protection: Procedures for monitoring radiation doses to staff and how staff are categorised by dose, with a justification of the chosen categorisation.

Please refer to our instructions for more details about the required information.

Supplementation may be requested should necessary information be missing. If you fail to respond to a request for supplementation, a decision will be reached based on the available documentation.

The Swedish Radiation Safety Authority’s licensing reviews are intended to ensure that your organisation can fulfil statutory requirements. This is the basis for our decision.

The time it takes to process an application varies depending on factors such as complexity, type of licence and the authority’s workload at the time in question. We will begin dealing with the matter when we receive a completed application. If the application is incomplete and supplementation is required, the processing time will be extended accordingly. If the requested information is not forthcoming, we may need to reach a decision based on the information we have to hand, or we may dismiss the application entirely.

A decision regarding a permit, or licence, under the Radiation Protection Act (2018:396) may be appealed to the Administrative Court in Stockholm. The decision includes instructions on how to lodge an appeal.

The application fee varies depending on the type of procedure and the number of devices covered by the application. Current fees are stated in the Ordinance (2008:463) on certain fees to the Swedish Radiation Safety Authority.

The application fee is debited when the application is submitted to the Swedish Radiation Safety Authority. The annual supervisory fee is first debited during the calendar year after the licensing decision is made.

Should the licensing review require a special investigation or other work that incurs significantly higher costs than normal, a supplementary fee of SEK 1,400 per working hour is payable.

The following acts, ordinances and regulations contain provisions of relevance to medical procedures involving ionising radiation:

Pursuant to Section 1 of Chapter 6 of the Swedish Radiation Protection Act (2018:396), it is prohibited to conduct unlicensed activities involving ionising radiation. Pursuant to point 1 in Section 2 of Chapter 9 of the same act, anyone intentionally or negligently breaching this prohibition may be sentenced to a fine or imprisonment for up to two years.