Brazil

ANVISA (Agência Nacional de Vigilância Sanitária), the Brazilian Health Regulatory Agency under the Ministry of Health, oversees medical device registration, notification, establishment licensing and post-market surveillance. For wireless and telecommunications functions, ANATEL approval may also apply.

Yes. No device may be placed on the market without ANVISA clearance. There are two routes: notification (notificação), a simplified process for Classes I–II, and marketing authorisation (registro), the comprehensive process for Classes III–IV.

Devices fall into four risk classes by intrinsic risk to the user, patient or operator: Class I (low), II (medium), III (high), IV (maximum), applying the rules in Annex I of RDC 751/2022. Where several rules apply, the most stringent governs. In vitro diagnostics follow their own harmonised classification under RDC 830/2023.

You need someone local. A foreign manufacturer cannot hold the authorisation directly. Market clearance must be requested by a Brazilian importer or legal representative formally established in the country. That representative is the registration holder and must hold an ANVISA operating authorisation (AFE, Autorização de Funcionamento da Empresa, or special authorisation, AE) to import, store and distribute the device.

Brazilian Good Manufacturing Practices under RDC 665/2022 apply, aligned with ISO 13485:2016. A valid ANVISA GMP certificate is a prerequisite for Class III–IV registration — the site inspection precedes the registration request. Class I–II devices subject to notification need no GMP certificate but must still comply with the GMP requirements.

Marketing authorisation (registro) is valid for 10 years and must be revalidated; notification carries no expiry date. Changes are graded into three tiers: an alteration of required approval (high relevance) must be cleared by ANVISA before implementation; an alteration of immediate implementation (medium relevance) may proceed once the application is submitted; a non-reportable alteration (low relevance) is controlled by the quality system alone.

Portuguese. Labels, instructions for use, manuals and labelling models must be supplied in Portuguese, regardless of whether the device is for professional or lay use. Labelling must carry the commercial name and model, legal manufacturer, the ANVISA notification or authorisation number, and a traceability identifier; equipment requires an indelibly attached label.