ANVISA (Brazilian Health Regulatory Agency)
The Brazilian Health Regulatory Agency, known as ANVISA (Agência Nacional de Vigilância Sanitária), is Brazil’s national authority responsible for regulating a range of health products.
Brazil · ANVISA
ANVISA: What Brazil Device Teams Need to Know
ANVISA is Brazil’s health regulatory agency.
Open the video guideWhat you’ll learn
- ANVISA is Brazil’s health regulatory agency.
- Separate medical devices from in vitro diagnostics when selecting the rules.
- For an overseas manufacturer, map the local applicant arrangement, the evidence for your route and the responsibilities after launch.
Read the video transcript
Entering Brazil with a medical device? ANVISA is central to the plan. The useful question is not simply whether you need approval, but which route fits your product.
ANVISA is Brazil’s health regulatory agency. For devices, it oversees product authorization, manufacturing requirements and safety once products are on the market.
Begin with your intended use and the device’s characteristics. Put the product, its technical description and its supporting evidence side by side before building a submission.
Under the general device framework, classes one and two use notification. Classes three and four require registration. Notification does not remove your responsibility to meet the applicable requirements.
Separate medical devices from in vitro diagnostics when selecting the rules. The main device framework is RDC seven fifty-one; in vitro diagnostics have their own regulation.
Your label and instructions also need attention. Review the Portuguese information and product identifiers against the dossier, rather than treating labeling as a last-minute design task.
For an overseas manufacturer, map the local applicant arrangement, the evidence for your route and the responsibilities after launch. Budgeting becomes more useful once those pieces are clear.
ANVISA requirements extend beyond getting a number on a certificate. Our glossary connects the agency’s role with Brazil’s classification, registration and post-market guidance.
Read the full glossary at Pure Global. One partner for medical device registration and regulatory support across more than thirty markets.
The Brazilian Health Regulatory Agency, known as ANVISA (Agência Nacional de Vigilância Sanitária), is Brazil’s national authority responsible for regulating a range of health products. Its jurisdiction covers medical devices, in vitro diagnostic (IVD) devices, active pharmaceutical ingredients, drugs, food and beverages, cosmetics, personal care products, sanitizing agents, and pesticides. ANVISA also oversees blood, tissue, organs, and transplants, as well as tobacco products. The agency issues resolutions (such as RDC 751/2022), technical regulations, and guidance documents that articulate regulatory requirements for products under its purview.
ANVISA carries out a range of activities to ensure that products on the Brazilian market meet safety and quality requirements throughout their life cycle. This includes pre-market registration, where the agency evaluates technical documentation and grants market authorization for regulated products. It also oversees Brazilian Good Manufacturing Practices (BGMP) by inspecting manufacturers in Brazil and abroad to verify compliance with Brazilian requirements. Once products are on the market, ANVISA monitors adverse events, product recalls, and safety alerts for regulated products. In addition, the agency works with customs to oversee the import, export, and transport of health-related goods through Brazilian ports of entry.
When was ANVISA established?
ANVISA was established in 1999 and operates under the Ministry of Health of Brazil.
What primary medical device regulations does ANVISA enforce?
Brazilian Federal Law 6,360/1976 is the legal basis for Brazilian medical device regulation. Current compliance obligations are primarily determined by subordinate regulations (RDCs) issued under its authority, specifically:
- RDC No. 751/2022 – medical device classification and authorization
- RDC No. 830/2023 – IVD regulation
- RDC No. 848/2024 – essential safety and performance requirements
Is the SNVS part of ANVISA?
ANVISA coordinates the SNVS, Brazil’s National Health Surveillance System, to monitor medical device safety and performance throughout the life cycle. SNVS oversees post-market surveillance and vigilance reporting, and registration holders are required to report adverse events to SNVS according to established time frames.
How do I contact ANVISA?
ANVISA directs most inquiries through the form on its official contact page. Messages may be submitted in Portuguese, English, or Spanish.
You can also contact ANVISA's Public Service Center Monday to Friday, 7:30 a.m. to 7:30 p.m. (except holidays) by phone: 0800 642 9782 (toll-free within Brazil).
Website: ANVISA
Address: Setor de Indústria e Abastecimento SIA, Trecho 5, Área Especial 57 Cobertura, Brasília – DF, Brasil, CEP: 71.205-050
Phone: 0800 642 9782
Contact: Contact form
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