Brazil's ANVISA expands ozone therapy approvals for diabetic wound care

On 1 July 2026, Brazil's health regulator ANVISA published Technical Note 41/2026, broadening the recognized indications for ozone‑emitting medical devices. The note now authorises the technology as an adjunct treatment for ulcerated diabetic foot wounds and acute infectious wounds in patients over 18, aiming to improve healing of hard‑to‑close lesions that cause many hospitalisations, amputations and high health‑system costs.

The update builds on a May 2026 resolution (RE 1.760/2026) that granted official registration to the Medplus line of devices produced by the Brazilian company Philozon, marking the first formal approval for ozone therapy in chronic wound care. Experts, including Dr Letícia Philippi of the Brazilian Association of Ozone Therapy, say the regulatory advance creates a safer environment for clinicians and patients and could accelerate wound healing, reduce complications and expand therapeutic options. The move is timely given the global burden of diabetic foot disease, with amputations occurring roughly every 20 seconds according to the International Diabetes Federation.