The Minister of Science and Technology has issued Circular No. 59/2025/TT-BKHCN, regulating radiation safety and preparedness and response to radiation and nuclear incidents. The Circular introduces comprehensive requirements on radiation safety in healthcare, with specific obligations applicable to radiation-related medical devices.
Read the full circular here in Vietnamese: [PDF] (English translation not available).
Purpose of the Circular
- To regulate radiation safety and emergency preparedness for radiation and nuclear incidents.
- To establish mandatory radiation safety requirements for medical devices used in healthcare.
- To enhance protection for patients, healthcare professionals, and the public from radiation exposure.
Key Highlights
General Radiation Safety Requirements for Medical Devices
All radiation medical devices used for diagnosis and treatment must:
- Obtain quality certification and comply with applicable Vietnamese national standards or equivalent international standards (e.g. IEC, ISO).
- Be accompanied by technical documentation covering operation, maintenance, and safety instructions, translated into Vietnamese.
- Display operating instructions and control panel symbols in Vietnamese or a language appropriate for the operator.
- Be equipped with radiation beam control mechanisms with clear “on” and “off” indications.
- Ensure accurate beam collimation to the intended patient treatment area.
- Maintain a uniform radiation field, with any non-uniformity clearly specified in technical documentation.
Safety Requirements for Diagnostic X-ray Equipment
In addition to the general requirements, diagnostic X-ray equipment must comply with the following:
- Leakage radiation from the X-ray tube must not exceed 1 mGy/hour at 1 meter, averaged over an area of 100 cm² for all operational modes.
- The fixed filtration value of the X-ray tube system (mm Al) must be clearly marked on the device housing.
- A beam size verification system is required, except for certain devices such as dental X-ray and mammography equipment.
- Parameters such as voltage (kV), current (mA), exposure time (s), or exposure setting (mAs) must be displayed on the control panel.
- Radiation exposure must automatically terminate once preset parameters are reached.
- For exposure modes, the devices must be equipped with an Automatic Exposure Control (AEC) system or a push-and-hold control switch.
- Minimum operator distance requirements apply:
- 2 meters between the operator and the X-ray tube;
- 3 meters for other X-ray equipment
- Fluoroscopy devices used for interventional procedures must include lead-rubber shielding with a minimum lead equivalent of 0.5 mm to protect medical staff.
Safety Requirements for Radiation Therapy Equipment
Radiation therapy equipment must comply with the general requirements and the following additional safeguards:
- The irradiation process must be interruptible from the control panel, with re-irradiation initiated only from the same location.
- Devices using radioactive sources must have at least two independent control mechanisms to automatically return the source to a safe position and terminate irradiation in emergencies.
- In the event of power failure, radioactive sources must automatically be secured until the system is restarted from the control panel.
- Remote-controlled radiation therapy and high-dose-rate (HDR) brachytherapy devices must allow for manual source retraction in emergencies.
- Gamma Knife systems must include a manual mechanism to close the source shielding window.
- Source containers for remote radiation therapy and HDR brachytherapy devices must display radiation warning signs in accordance with national technical standards.
Additional Regulatory Coverage
The Circular also includes requirements relating to:
- Sealed radioactive sources and radiopharmaceuticals.
- Radiation measurement equipment and personal protective equipment.
- Equipment validation and calibration of radiation measurement devices.
- Working room requirements for radiation equipment.
- Radiation exposure monitoring and control.
Implications to Clients
Companies operating in the radiation-related medical device sector should ensure:
- Product compliance with national or applicable international radiation safety standards.
- Comprehensive Vietnamese-language documentation for operation, maintenance, and safety.
- Adequate training of personnel in radiation safety and device operation to meet regulatory requirements.
Effective Date
January 1, 2026
Upon entry into force, this Circular repeals the following regulations:
- Circular No. 19/2012/TT-BKHCN dated November 8, 2012, by the Minister of Science and Technology, regulating occupational radiation control and public exposure;
- Circular No. 13/2014/TTLT-BKHCN-BYT dated June 9, 2014, by the Minister of Science and Technology and the Minister of Health, regulating radiation safety in healthcare;
- Circular No. 13/2018/TT-BKHCN dated September 5, 2018, by the Minister of Science and Technology, amending some provisions of Circular No. 13/2014/TTLT-BKHCN-BYT;
- Circular No. 23/2012/TT-BKHCN dated November 23, 2012, by the Minister of Science and Technology, guiding the safe transport of radioactive materials;
- Circular No. 22/2014/TT-BKHCN dated August 25, 2014, by the Minister of Science and Technology, regulating the management of radioactive waste and spent radioactive sources;
- Circular No. 12/2023/TT-BKHCN dated June 30, 2023, by the Minister of Science and Technology, regulating preparedness and response to radiation and nuclear incidents, as well as planning and approving response plans for such incidents.
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Vietnam, please contact sales@andamanmed.com.
