Regulatory technical dissemination note

Resolution 1811 of 2025: Update of the regulatory framework for equipment generating ionizing radiation in Colombia

Resolution 1811 of 2025, issued by the Ministry of Health and Social Protection of Colombia, regulates the use of equipment that generates ionizing radiation, the provision of radiological protection services and quality control in medical, veterinary, industrial and research practices. This standard replaces Resolution 482 of 2018, incorporating standards from the International Atomic Energy Agency (IAEA), particularly the Specific Safety Guide SSG-44 (2023). Five central aspects stand out: mandatory licensing, categorization of medical practices, technical and human talent requirements, strengthening inspection and surveillance, and the transitional provisions that

Ionizing radiation is used in multiple sectors: health, industry, veterinary medicine and research with applications that provide great diagnostic and therapeutic benefits. However, its inappropriate use represents a significant risk to patients, workers and the general public. Therefore, it is necessary to have an updated regulatory framework that comprehensively regulates its application.

In response to this need, the Ministry of Health and Social Protection issued Resolution 1811 of 2025, published in the Official Gazette on September 5, 2025. This resolution replaces Resolution 482 of 2018, harmonizes Colombian regulation with the international standards of the International Atomic Energy Agency (IAEA) and reinforces the control and surveillance processes in the national territory.

Key aspects of Resolution 1811 of 2025

Mandatory licensing

Any practice that involves equipment that generates ionizing radiation requires a license issued by the departmental or district health secretariats. Types of license: medical, veterinary, industrial or research practices, and provision of radiation protection and quality control services. The validity ranges between 4 and 5 years depending on the type of license, with the possibility of renewal after technical and documentary verification.

Categorization of medical practices

Three levels of complexity are established:

– Category I: low complexity (ej. periapical dental radiology, bone densitometry, radiography of medical samples).

– Category II: medium and high complexity (e.g. tomography, mammography, fluoroscopy and conventional fixed or portable radiology).

– Category III: radiotherapy in its basic, intermediate and advanced modalities, considered the highest risk and, therefore, with stricter requirements.

Technical and human talent requirements

Providers must meet specific conditions:

– Technical Director: postgraduate degree in medical physics or another related discipline, minimum experience in radiation protection and quality control.

– Radiation protection officer: professional responsible for guaranteeing radiation safety at the facility.

– Mandatory training: certified courses in radiation protection for all occupationally exposed personnel.

– Quality protocols:adoption of international guidelines (e.g. TECDOC of the IAEA, AAPM guides), guaranteeing safe and effective performance of the equipment.

Inspection and surveillance

The responsibility falls on the territorial health authorities, which must evaluate license applications and documentation, carry out verification visits at the facilities, require quality control reports valid for two years and issue administrative acts of authorization, suspension or modification.

Transitional provisions and validity

Current licenses continue until their expiration. Radiotherapy services must be adjusted to Category III in the next renewal. The radiation protection course will be required two years after entry into force. The rule will come into effect six months after its publication, repealing Resolution 482 of 2018.

Some impacts on public health are the reduction of risks due to undue exposure to radiation, in health services the strengthening of diagnostic and therapeutic quality, in occupational safety the integration of specific protocols in risk management systems and finally in research and industry greater control of practices and strengthening of institutional trust.

Conclusion

Resolution 1811 of 2025 constitutes a milestone in Colombian regulatory policy regarding ionizing radiation. Its comprehensive approach covers licensing, categorization of practices, technical requirements, health surveillance and training of human talent.strengthens radiation safety and harmonizes national regulations with international IAEA standards.

This regulatory framework guarantees a safer environment for patients, professionals and the general population, consolidating a culture of protection and quality in the use of radiological technologies in Colombia.

Bibliography

Ministry of Health and Social Protection. Resolution 1811 of 2025. Which regulates the use of equipment that generates ionizing radiation, the provision of radiological protection and quality control services, and dictates other provisions. Official Gazette No. 53,234, September 5, 2025.