AEPROMO StatementAugust 29, 2025
The Brazilian Federal Council of Medicine Regulates Ozone Therapy in Human Medical Practice
Summary
Brazilian Federal Law 14,648 of 2023 (August 4) authorised ozone therapy throughout the national territory.
The Brazilian Federal Council of Medicine (CFM), bound by this federal law, very recently (August 29, 2025) regulated the use of ozone therapy as an adjuvant medical procedure in the treatment of wounds and musculoskeletal pain.
Previously, the CFM had spoken out vehemently against ozone therapy as a medical treatment, threatening physicians with sanctions — including lifetime revocation of medical licences — if they practised it.
The 2025 CFM resolution specifies that ozone therapy as an adjuvant medical procedure in the treatment of wounds and musculoskeletal pain is an exclusively medical procedure.
Treatment must be preceded by a nosological diagnosis of the type and cause of the injury to reduce the risk of complications and improve management of adverse effects.
The CFM states that ozone therapy is a medical procedure and a complementary treatment.
Physicians must keep systematic records including:
Indication
Technique used
Ozone concentration
Exposure time or volume injected
Frequency of applications
Clinical results
Brazil has also authorised and regulated ozone therapy in:
Dentistry (2015), Physiotherapy (2018), Pharmacy (2020), Nursing (2020), Veterinary Medicine (2020), and Biomedicine (2020).
The Madrid Declaration on Ozone Therapy
The Madrid Declaration on Ozone Therapy affirms that ozone therapy is a complementary treatment and a medical procedure, supporting the regulation of the therapy.
AEPROMO has provided legal support to Brazilian colleagues through detailed legal analyses on the evolution of ozone therapy in the country.
Details of the CFM Regulation
The Brazilian Federal Medical Council (CFM) Resolution No. 2,445/2025 regulates ozone therapy as a complementary medical procedure in the treatment of wounds and musculoskeletal pain, repealing Resolution 2,181/2018.
This resolution was issued to comply with Federal Law No. 14,648/2023, which authorised ozone therapy nationwide.
Context
For many years, the CFM had opposed ozone therapy, even threatening sanctions for doctors who used it.
As recently as August 6, 2020, it declared ozone therapy not recognised for the treatment of COVID-19 or any other disease, warning of investigations for those who did not comply with its ethical standards. (Source)
However, under the 2023 federal law, the CFM was obliged to authorise the procedure. (Law reference)
Content of Resolution No. 2,445/2025
Approved Medical Indications
Ozone therapy is authorised as a complementary medical therapy for the treatment of:
Diabetic foot ulcers
Ischemic arterial ulcers
Acute infectious wounds
Chronic venous ulcers
Treatment must be topical, using an airtight plastic bag (ozone bag), ozonised oil, or ointment, under medical protocol guidance and in hospital or medical facilities meeting Group 2 standards.
Ozone therapy for neoplastic wounds is expressly prohibited, except in approved clinical research.
Musculoskeletal Pain Conditions
Ozone therapy is also authorised as a complementary medical therapy for:
Knee osteoarthritis
Low back pain due to herniated disc
Knee osteoarthritis: intra-articular ozone injections in specialised clinics or Group 3 facilities.
Low back pain: paravertebral or intradiscal ozone injections performed only by qualified physicians, in surgical or hospital settings under aseptic, image-guided conditions.
Professional Requirements
Procedures may only be performed by physicians with an RQE (Specialist Qualification Registry) in:
Anesthesiology
Neurosurgery
Orthopaedics and Traumatology
Interventional Radiology / Angioradiology
Pain Medicine
All ozone-generating medical equipment must be certified by Anvisa (National Health Surveillance Agency).
Each treatment must include a recorded diagnosis, ozone concentration, frequency, and results.
Regulation of Ozone Therapy in Other Health Fields
Brazil leads globally in ozone therapy regulation, with standards for multiple professions:
Dentistry (2015), Physiotherapy (2018), Pharmacy (2020), Nursing (2020), Veterinary Medicine (2020), and Biomedicine (2020).
Excerpts from the Madrid Declaration (ISCO3, 4th Edition, 2025)
Ozone therapy is a complementary treatment and should be performed alongside, not instead of, allopathic medicine.
Ozone therapy is a medical procedure and must be prescribed and performed by physicians with scientific rigour.
The Declaration supports regulation and legalisation of ozone therapy, noting it is already legal in 15 countries.
(Source)
AEPROMO’s Role in Brazil’s Legal Evolution
Since 2008, under the leadership of Dr. Adriana Schwartz, AEPROMO has advocated for the lawful and ethical practice of ozone therapy globally.
AEPROMO’s contributions to the Brazilian process include:
Providing legal analyses and reports since 2011
Supporting ABOZ (Brazilian Association of Ozone Therapy) in petitions to the Federal Council of Medicine
Co-signing international letters with 21 national ozone associations urging regulation (2015)
Publishing key documents like “Ozone Therapy and Legislation – Analysis for its Regularisation” and “Legal Status of Ozone Therapy in Brazil – Update”
(Full references here)