Every ionising radiation device in healthcare (X-ray machines, CT scanners, radiotherapy units, radioactive sources in nuclear medicine) sits under a licensing regime separate from the medical practice licence: the radiation work permit. From 01 January 2026 this regime operates under the Atomic Energy Law 94/2025/QH15 replacing the 2008 Atomic Energy Law, so healthcare facilities and clinic investors need to re-check the entire legal basis of their existing permits.
Legal basis
- Atomic Energy Law 94/2025/QH15 (adopted 27 June 2025): Article 72 provides that the law takes effect from 01 January 2026 and the Atomic Energy Law 18/2008/QH12 ceases to be effective from that date; Article 73 contains the transitional provision for licences already granted.
- Rules on radiation work licensing, radiation safety assessment and the decentralisation of licensing authority between the central radiation safety authority (the Vietnam Agency for Radiation and Nuclear Safety, Ministry of Science and Technology) and provincial authorities.
- Rules on radiation safety training, radiation worker certification and inspection and verification of radiation-emitting equipment in healthcare facilities.
Opening an X-ray or CT room: which radiation safety permit is needed?
A medical radiation device may be put into use only when the facility holds a radiation work permit for that exact device and radiation work, granted on the basis of the facility radiation safety assessment file. The safety assessment is the core part: room design with shielding materials meeting requirements for the machine power and beam direction, safe operating procedures, protective equipment and dose measuring devices, a radiation incident response plan and radiation safety responsible personnel. Licensing authority is decentralised by radiation work character: high-risk radiation work such as radiotherapy and nuclear medicine is licensed and managed by the central radiation safety authority; ordinary diagnostic X-ray equipment falls under provincial authority under current decentralisation. The medical examination and treatment licence of the clinic is a parallel condition and does not replace the radiation permit: a clinic with a medical licence but no radiation work permit may not yet operate an X-ray machine or CT scanner. When changing equipment, changing the machine location or expanding radiation work, the facility must complete amendment, supplementation or re-licensing procedures correspondingly before putting the change into operation. For permits granted under the old law, Article 73 of the Atomic Energy Law 94/2025 allows an existing radiation work permit to continue in use until the expiry date stated on the permit, after which renewal and new licensing follow the new law.
What certificates do radiation equipment operators need?
Radiation workers (persons directly operating radiation-emitting equipment, medical imaging technicians working in a radiation environment) must be trained in radiation safety and hold the certificate or training attestation prescribed for each work position, and the facility must assign a radiation safety officer meeting professional conditions to supervise all radiation activity at the facility. Radiation safety training is not a one-off: radiation workers fall within the group requiring periodic refresher and update training at the prescribed cycle, and training records form part of the radiation safety file reviewed by inspectors. Alongside certification, the radiation worker protection regime includes periodic health examinations for the radiation-exposed occupation, personal dosimeter wearing and accumulated dose tracking, and work limits for special groups under labour protection rules for radiation environments. A facility hiring technicians from an external service provider remains responsible for ensuring that the person operating its machine holds sufficient certification at the time of operation; radiation safety responsibility cannot be outsourced.
How often is periodic radiation safety inspection?
A facility using radiation equipment bears two overlapping inspection layers. The first layer is self-assessment and internal inspection on the facility operating cycle: image quality and device output dose checks, verification of radiation-emitting equipment by a qualified unit at the cycle prescribed for each device type, and radiation level measurement at work positions and room boundaries after every change of equipment or shielding structure. The second layer is inspection and examination by the radiation safety management authority on periodic and ad hoc plans, reviewing the permit, the safety assessment file, staff training records, equipment verification results and the incident log. The concrete cycle for each device type and inspection content is set in the guiding instruments of the Atomic Energy Law 94/2025; the facility should build its own radiation compliance calendar (permit, equipment verification, refresher training, staff health examinations) as the new law takes effect instead of using the old calendar under the 2008 frame, because this transition period is exactly when file discrepancies are most easily detected. Operating radiation equipment on an expired permit or without a permit is a violation subject to penalties and suspension of the radiation work, and generates compensation liability if an exposure incident occurs.
Recommendations for clinic and hospital investors
Three tasks for the transition to the new law: inventory all existing radiation work permits, check their remaining term under Article 73 of Law 94/2025 and plan renewal under the new law before the old permit expires; review the training files and certificates of all radiation workers, including operating contractor personnel; and include radiation safety items (shielding design, equipment verification) in the investment budget from the room design stage, because altering shielding structure after the clinic is operating is a costly intervention requiring machine shutdown.
Frequently asked questions
Does opening an X-ray or CT room need a radiation safety permit?
It needs a radiation work permit for the exact device, granted on the basis of a radiation safety assessment file (shielding design, operating procedures, safety responsible personnel). From 01 January 2026 the Atomic Energy Law 94/2025 applies in place of the 2008 law; previously granted permits continue until expiry under Article 73. A medical practice licence does not replace the radiation permit; licensing authority is decentralised between the Vietnam Agency for Radiation and Nuclear Safety and provincial authorities by radiation work type.
What certificates do radiation equipment operators need?
Radiation workers must complete radiation safety training and hold the certificate or training attestation prescribed for the work position, with periodic refresher training; the facility must assign a qualified radiation safety officer. The accompanying regime includes personal dosimeters, accumulated dose tracking and periodic health examinations for the radiation-exposed occupation.
How often is periodic radiation safety inspection?
At the cycle prescribed for each device type and inspection content in the guiding instruments of the Atomic Energy Law 94/2025, covering radiation-emitting equipment verification, workplace radiation measurement and inspection by the radiation safety authority. The facility should build a separate compliance calendar for the new-law transition instead of using the 2008 frame calendar.
This article has been quality-reviewed by the FLAW AI Legal Council