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The Ministry of Public Health issued the Regulation on Comprehensive Occupational Health Services (SISAT) through Agreement No. 00004-2026, published in the Second Supplement to Official Gazette No. 304 on June 12, 2026. This new regulation expressly repeals the long-standing Regulation for the Operation of Company Medical Services, issued in 1978, which governed this matter for nearly five decades.
The new regulation is mandatory for all employers in the public and private sectors, the Armed Forces, citizen security entities, and Social Security affiliates throughout the national territory.
Below is a summary of the most relevant provisions:
- Five Compliance Categories
Workplaces are classified into five categories (I to V) based on the number of employees and the level of occupational risk. The applicable category determines the required healthcare personnel and the minimum service coverage:
- Category I (1–24 employees, medium- and high-risk activities) and Category II (25–49 employees, medium- and high-risk activities) require a physician with a fourth-level degree in Occupational Health and Safety, providing services through periodic visits.
- Category III (50–99 employees) maintains the same physician profile with periodic visits.
- Category IV (100–199 employees) requires a full-time physician and nursing staff.
- Category V (200 employees and above) requires full-time physician, nursing, and psychology services, with the mandatory inclusion of a specialist in Occupational Medicine for workplaces with 1,000 or more employees.
- Exemption for Low-Risk Micro and Small Enterprises
Companies with 1 to 24 employees engaged in low-risk activities are exempt from implementing a SISAT. However, they must obtain an annual Occupational Health Certificate and conduct occupational assessments whenever required by the nature of the work or applicable regulations.
- Outsourcing of Services
Employers may engage authorized external providers to implement SISAT services. Such providers must comply with the technical requirements established in the regulation and obtain an operating permit from the National Health Authority (ACESS).
- Compliance Deadlines
- Employers and external service providers have a period of two (2) years to obtain the operating permit for their healthcare facilities. Within the same period, medical and nursing personnel must obtain certification in Basic Life Support (BLS).
- Physicians, nurses, and psychologists providing SISAT services must complete their registration and authorization process before ACESS within a maximum period of one (1) year. Without this requirement, they will not be permitted to continue performing their duties.
- The National Health Authority will issue guidelines establishing the availability of medications required for each facility according to its SISAT category within six (6) months.
- The National Health Authority will issue regulations defining the minimum infrastructure and equipment requirements within a maximum period of eight (8) months.
For further information or labor advice regarding the application of these regulations, please contact Tobar ZVS at laboral @ tzvs.ec
© TobarZVS
This publication contains information of general interest and does not constitute legal opinion on specific issues. Any analysis will require legal advice from the Firm.