Buying imported equipment for Brazilian care
Brazil's 1976 health law sets the ground rule. No product, whether imported or made in Brazil, may be offered for sale or supplied before it is registered. That rule binds Brazilian makers as much as importers. In practice, that raises two questions before any comparison of quotes. Is the model already notified or registered with ANVISA by a company responsible for it in Brazil? And how will it reach a ward in Porto Alegre, or a clinic far up the Amazon?
We're MediGear, and our medical equipment distribution company is registered in England and Wales. We quote, document and ship certified equipment, and our healthcare buyers come from more than 80 countries. Please tell us what medical technology you need. We look for verified makers who can supply it and check what a Brazilian importer will face before the quote reaches your team. You can start on our buyers page without opening an account.
Brazilian buyers, we quote for
We quote for buyers both inside and outside the SUS, Brazil's public healthcare system:
- State and city health departments buying for SUS hospitals and clinics
- Federal university hospitals in the Ebserh network, which runs its own central purchasing
- Public teaching hospitals such as the Hospital de Clínicas de Porto Alegre
- Private diagnostic imaging services, from X-ray and CT to ultrasound and mammography
- Charity and private hospitals, for example Hospital Sírio-Libanês in São Paulo and Brasília
- Federal institutes such as INCA, the national cancer institute
- Importers and medical equipment distributors in Brazil that hold ANVISA's operating authorisation
Their buying rules are not the same. A university hospital will normally tender under Law 14.133 of 2021 and post the notice on the PNCP, the national site for public contracts, so the quote must fit the bid. So will a city health department. A private clinic replacing one of its diagnostic imaging devices wants a clear quote and an importer ready to bring it in. We ask which route you are on before we quote, because it changes the paperwork.
ANVISA notification or registration
ANVISA sorts devices intended for use in Brazil into four risk classes under RDC 751/2022, which also requires their labels and instructions for use to be in Portuguese. Classes I and II are notified, while classes III and IV require full registration; in each case, the holder must be a manufacturer or importer responsible for the device in Brazil. Medical electrical equipment also needs a certificate from a test body in the Inmetro system.
If the model you want has no ANVISA number, a Brazilian holder would have to notify or register it first, with the manufacturer's written authorisation. An overseas seller cannot hold that registration. Diagnostic imaging systems in Brazil are no exception, as RDC 611/2022 lets a radiology service use only products regularised with ANVISA. We cannot hold an ANVISA registration or give regulatory advice, as we are not a Brazilian importer. Our quote states each unit's certification for your team to check.
Radiology imaging under RDC 611
Before you install imaging units in Brazil, such as X-ray or CT systems, plan the room. X-ray work is regulated by ANVISA itself, through RDC 611/2022 and the local health services that apply it. The resolution prioritises shielding: the shielding project, signed by a qualified professional, is approved before anything else is assessed. ANVISA's inspection checklist for interventional radiology also expects the building plan to be approved again before any change to the service. Nuclear medicine and radiotherapy are licensed separately by ANSN, the national nuclear safety authority.
Once a unit is installed in the room, it needs an acceptance test, followed by regular tests under the normative instructions of 2021. A CT scanner gets weekly image checks, mammography daily image checks, and most X-ray tests come round once a year, with a radiation survey every four years. The maker must also certify the tube's leakage shielding at installation. Raise these points while the quote is open, and we'll send the technical file.
Power, Inmetro and software checks for Brazil
For Brazilian sites, these are the points we settle with makers before a quote goes out:
- 127 V or 220 V at 60 Hz. Low-voltage supply runs at 127 V or 220 V, and the IEC tables list plug types C and N for Brazil. A unit built for 50 Hz may need a different factory build, not just an adapter.
- Inmetro and testing. The Inmetro-system certificate must stay valid for the ANVISA file, and X-ray units need their acceptance test on site. Ask for the service manual and test data early.
- Spares and supplies. Check that probes, electrodes, filters and cartridges will be supplied for as long as you plan to run the unit, and ask how long X-ray detectors for your unit will be supported. We check compatibility and tell you which spare parts and consumables you can reorder from us.
- Portuguese software. On diagnostic imaging equipment, check the interface language, DICOM and HL7 options, and any link to the national health data network, the RNDS, with your IT team.
We ask the maker open questions before quoting, as a frequency or language setting is far easier to fix now than at commissioning.
Import papers for Brazil
Customs and health checks on medical devices in Brazil run through Siscomex, the federal trade system, so every order ships with a full set of papers:
- A commercial invoice and a detailed packing list
- A bill of lading or air waybill matching the invoice
- The certificate of origin and the NCM code for each line
- A statement that each unit is new, as the import licence must say whether goods are new or reconditioned
- Portuguese labels and instructions, plus the Inmetro-system certificate
Wood packaging is inspected as well. Portaria MAPA 514/2022 sets the rules for wooden crates and supports used on goods Brazil imports, listed on the government's Vigiagro legislation page, and the agriculture ministry's Vigiagro service checks them at ports, airports and border posts. So we ask for ISPM 15-treated and marked timber from the outset.
Quote, approval and the route to Brazil
- Open a request. List the model, quantity, facility and the importer who will hold the paperwork, by RFQ form or email.
- Study the quote. Catalogue items are usually quoted within 48 hours, and the quote shows the product, lead time, certification and route.
- Send written approval. A signed or emailed approval from you is what starts the order.
- Ship to Brazil. Sea freight into Paranaguá or another container port you nominate, or air freight into an international airport for smaller or urgent items.
Our part ends at the port or airport you choose; import is yours after that. Your company must first be enabled in Siscomex with its representatives registered, as the Receita Federal import guide explains. Then the declaration goes through the Duimp, where ANVISA gives its release before the goods are handed over. For Manaus and the Amazon, dry-season river levels can slow the last leg, so tell us early.
New units, projects and refurbished requests
Most catalogue lines can be quoted as one unit, from a patient monitor to an autoclave, so there is no need to buy medical equipment and supplies in bulk. We also quote multi-line requests for new wards and public tenders; see government tender for that work. Hospital labs can look at Lab, Pathology and Blood Bank. Used and refurbished medical devices, including our refurbished range, are a different matter. Under RDC 579/2021, used devices cannot be imported unless they are destined for reconditioning in Brazil, and reconditioned units are allowed only under an ANVISA registration that names the reconditioning plant. So most quotes for refurbished medical equipment cannot go to Brazil.
Disclaimer
What follows is general information for Brazilian buyers. Please read it as background, not as an offer to supply or as legal, regulatory or customs advice. Every quote depends on what makers can supply, and only a written agreement on both sides makes an order firm. A device can be supplied in Brazil only once a Brazilian holder has notified or registered it with ANVISA, and X-ray services must also meet RDC 611/2022 and the rules of their local health service. Used devices fall under RDC 579/2021. Import clearance and the regulatory position of your purchase rest with you. We do not act as a Brazilian importer or registration holder.
Do you have the model number?
Which importer will bring the unit in, and through which Brazilian port? Email those details with the model number, a data sheet or a photo, and our quote for a new unit will show its ANVISA position and what your importer needs to file.
Frequently Asked Questions
Only the model or specification. No account is needed: put the details into the RFQ form on the buyer's page, or email them at connect@medigear.uk. We quote for SUS hospitals, federal university hospitals, philanthropic and private groups, imaging and diagnostic screening services, clinics, and Brazilian importers, and we send every quote by email.
Yes. Class I and II devices are notified, and class III and IV devices are registered, and the holder must be a manufacturer or importer responsible for the device in Brazil. Our quote lists the unit's certification, so your importer can check the ANVISA position before you order.
A Brazilian holder would need to notify or register it first, with the manufacturer's written authorisation, and medical electrical equipment also needs an Inmetro-system certificate. Ask your importer or a regulatory adviser before you commit. We can often suggest a comparable model that already has an ANVISA number.
For digital X-ray diagnostic imaging systems, RDC 611/2022 requires that the shielding project be approved first, and that new equipment be approved by the health authority before installation. After assembly, the unit needs an acceptance test, followed by regular quality control tests. We send the technical data your physicist or health surveillance office asks for.
Sea freight goes into Paranaguá or another container port you nominate, and air freight goes to an international airport for smaller or urgent items. We deliver to the point you name, after which clearance and the onward journey to your hospital or clinic are yours to handle.
Your importer does, using Siscomex and the DUIMP declaration, and ANVISA must release the goods before they are handed over. We provide the commercial invoice, packing list, transport document, certificate of origin, NCM codes and the certificates your importer needs for each step.
Yes. On most catalogue lines, a single unit is no problem, and we'll tell you right away if a manufacturer sets a minimum order quantity. If the last leg is a long road haul or a river barge, say so,o and we will ask for packing that suits it.
The maker's stock, the route and the pace of the ANVISA and import steps set the timetable. Used and refurbished medical devices rarely qualify for import, so most lead times are for new stock. Each quote gives the lead time and route, and we send email updates from dispatch until the unit reaches your port.