Date: October 29, 2025
The Federal Council of Medicine (CFM) has officially authorized the use of ozone therapy for specific medical indications through Resolution CFM No. 2,445/2025. This new resolution revokes Resolution CFM No. 2,181/2018, which had previously classified ozone therapy as an experimental procedure in Brazil. This update represents an important milestone for manufacturers and distributors of ozone therapy-related products targeting the Brazilian market.
What is now authorized ?
Under Resolution CFM No. 2,445/2025, ozone therapy is authorized as an adjuvant medical therapy for the following conditions:
Wound Treatment
- Diabetic foot ulcers
- Ischemic arterial ulcers
- Acute infectious wounds
- Chronic venous ulcers
Musculoskeletal Pain
- Knee osteoarthritis
- Low back pain due to herniated disc
Application Requirements
The CFM resolution strictly regulates the method of application:
- Ozone therapy must be applied exclusively via topical routes
- Authorized methods include:
- Sealed plastic bag technique (“ozone bagging”)
- Ozonated oil
- Ointment
- Concentration and frequency must follow care protocols based on available scientific evidence
Systemic or injectable ozone applications remain outside the scope of this authorization.
ANVISA’s current position on ozone therapy devices
Despite the CFM’s new authorization, regulatory alignment with the ANVISA (Brazilian Health Regulatory Agency) remains subject to its own technical framework. Technical Note No. 43/2022/SEI/GQUIP/GGTPS/DIRE3/ANVISA currently restricts the use of ozone therapy medical devices to the following indications:
Dentistry & Related Fields
- Treatment of dental caries (antimicrobial action)
- Prevention and treatment of periodontal inflammatory/infectious conditions
- Support in root canal sanitization (endodontics)
- Support in oral surgery tissue repair
- Aesthetic procedures (skin cleansing and asepsis support)
At present, ANVISA’s technical framework does not explicitly include the newly authorized wound and musculoskeletal indications described in Resolution CFM No. 2,445/2025.
Official sources
Federal Council of Medicine (CFM) : Resolution CFM No. 2,445/2025
ANVISA : Technical Note No. 43/2022/SEI/GQUIP/GGTPS/DIRE3/ANVISA