Licences and notifications for dental practices

This page contains information for those who conduct, or plan to conduct, dental procedures using panoramic x-ray equipment, cone-beam computed tomography (CBCT), portable/handheld x-ray scanners or intraoral scanners. It explains when a licence or notification is required, as well as how to apply for a licence or submit notification.

A licence is required from the Swedish Radiation Safety Authority to conduct dental procedures involving ionising radiation. Those applying for a licence must meet the requirements set out in the Swedish Radiation Protection Act (1988:220), Radiation Protection Ordinance (2018:506) and applicable regulations issued by the Swedish Radiation Safety Authority. No licence is required to use intraoral scanners but these are subject to a notification obligation.

Licensable dental care

The following procedures require a licence from us:

  • Procedures involving your own panoramic x-ray equipment.
  • Procedures involving your own cone-beam computed tomography (CBCT) equipment.
  • The use of panoramic x-ray equipment or CBCT owned by a different company.
  • Procedures involving portable/handheld x-ray equipment.
  • Procedures involving stationary equipment for intraoral scanning that deviates from the requirements of Swedish Radiation Safety Authority Regulations (SSMFS 2018:2) concerning Activities Subject to a Notification Obligation.

How to apply for a licence

Complete the application form for a licence to use ionising radiation in dental practices.

Your application needs to include the following information:

A register extract:

  • A register extract showing that your practice is registered in the Health and Social Care Inspectorate’s (IVO’s) Healthcare Provider Register.

Equipment:

  • List and describe the x-ray equipment you use, including supplier information and who is responsible for maintaining and replacing existing equipment.

Premises:

  • Details of the clinics in which your dental practice is conducted, including the location of x-ray equipment and radiation shielding on the premises.

Competence:

  • The names and any specialities of staff who will be assigned to radiological supervision functions.
  • Certification of completed supplementary training for staff who will be assigned to radiological supervision functions (applies to activities using panoramic x-ray equipment).
  • Description of how introductory courses and continuing professional development courses for staff on radiation protection and handling x-ray equipment are organised.

Organisation:

  • Estimated number of examinations.
  • Whether the equipment will be used for specialist examinations and your procedures for ensuring that treatment is justified.

If specialist dental x-ray diagnosis is offered, the following information is also required:

  • A description of your radiation protection organisation and contact details for your medical physicist.
  • Copies of agreements with dental radiology specialists and medical physicists for CBCT.

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.

Processing time

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.

Appealing a decision

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.

Fees

The application fee for dental x-ray diagnostics is SEK 2,200 per generator.

Criminal liability

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.

Dental procedures subject to a notification obligation

Anyone planning to use an intraoral scanner in their dental practice is required to register their operation with the authority.

How to register your operation

  1. Log in to our e-service using your Freja eID or BankID.
  2. Select the type of operation you wish to register.
  3. Provide the following details:
    1. Invoicing address
    2. Invoice reference
    3. Preferred means of invoicing
    4. Contact details for someone who can answer any questions
    5. The make, model and serial number of the equipment (the serial number can be registered at a later date).
    6. Any supplier information
    7. Address where the operation is carried out
    8. Clinic ID (each clinic has a unique identity number beginning with 333 + five digits issued by Försäkringskassan).
  4. You also need to supply details of the equipment to which your application relates.

When you have signed your notification, a confirmation will be sent to your email address. This means that your notification has been approved. Save this confirmation as it is only generated once when you register.

How to renew your notification

Your notification is valid for five years. You can renew it no earlier than six months before it expires. The renewal must be submitted via our e-service.

Power of attorney for representatives

You have automatic authorisation to log in to the e-service if you are an authorised signatory, CEO or director of the company. If the signatures of multiple directors are required, you will need power of attorney to log in. Power of attorney is also required if someone other than an authorised signatory or CEO is representing the organisation. Power of attorney is also required for sole traders, limited partnerships, economic associations, publicly owned companies and public authorities.

You can apply for power of attorney in two ways:

  1. The authorised signatory or CEO can log in and delegate authority to represent the organisation. The representative must then log in and approve the information in the e-service.
  2. The representative can log in directly to the e-service and enter and send their details.

In both cases, documentation of delegation must be attached and signed and approved by the authorised signatory or CEO. This must state the name and job title of the delegator and the name and personal identity number of the delegatee.

The Swedish Radiation Safety Authority will check the information and a case officer from the authority must approve power of attorney. A confirmation document will be emailed to the representative once power of attorney has been approved.

Fees

According to the Ordinance (2008:463) on certain fees to the Swedish Radiation Safety Authority, the fee for notifiable activities is SEK 1,850.

When you decommission your operation

If you no longer conduct an operation registered with the Swedish Radiation Safety Authority, you can deregister by emailing us at Tillstandsprovning-stralskydd@ssm.se. Please state the registration number.

Do you have any questions or concerns?

Do you have any questions or concerns about the application or notification process, or suggestions for improving the information on this page or the user experience of our e-service? If so, please contact us at Tillstandsprovning-stralskydd@ssm.se.

Information on how we process personal data

The Swedish Radiation Safety Authority is the controller of processing for the personal data you supply in your application or registration. We process personal data in compliance with Regulation (EU) 2016/679, the General Data Protection Regulation (GDPR).