DOMO Salute sells hospedagem de registros — Brazilian Registration Holder plus post-market work plus import authorizations (DDR) for named distributors. That is the Brazil product closest in shape to an independent holder who will also unlock the border. The public page is domosalute.com.br/pt/como-ajudamos/brazilian-registration-holder/ (retrieved 23 August 2026). This article names that offer fairly, then contrasts it with multi-country market access from bioaccess®.
What DOMO Salute publishes
They describe BRH as a fundamental step for international companies that want to regularize medical devices with ANVISA. As legal representative they assume responsibility for product regularization and ongoing compliance so manufacturers and local distributors can focus on commercial growth. As an independent BRH they advertise flexibility in choosing commercial partners and agility in managing records.
Four blocks on the hospedagem page:
- Local representation — technical and legal representative in Brazil; ANVISA regularizations.
- Post-market — complaints, adverse-event notifications, corrective actions.
- Renewals and regulatory updates — renewals, regularization updates, legislation monitoring, real-time alerts.
- Import authorizations and compliance — they issue import authorizations (DDR) for designated distributors and qualify those partners.
Related “Como Ajudamos” tiles: medical-device regularization including SaMD and IVD; hospedagem (they assume titularidade and sit between the international manufacturer and ANVISA); INMETRO & ANATEL certification support; BPF (good manufacturing practice) certification documentation for ANVISA.
They do not publish a multi-country holder subscription or government fees plus certified translations inside one annual LATAM fee. They are a Brazil hospedagem + DDR shop. That is a strong one-country product — especially versus a BRH that refuses to touch import.
Why DDR matters in Brazil
ANVISA names a single detentor de registro. That detentor can authorize multiple importadores without re-registering the device. Import letters / DDR are how a neutral holder lets several distributors land product without becoming the exclusive commercial channel. A manufacturer that gives the BRH role to Distributor A has to unwind that appointment to add Distributor B. A manufacturer that keeps an independent BRH (DOMO’s model, or bioaccess®’s Brazilian entity) adds and drops importadores on paper. Country page: Brazil ANVISA.
DOMO Salute vs bioaccess®
| Dimension | DOMO Salute | bioaccess® |
|---|---|---|
| Public product | Independent BRH / hospedagem + DDR + post-market | Holder under contract (own entity in Colombia; local partner elsewhere) |
| Import | DDR for designated distributors | Holder/IOR under contract, with our local partner in Brazil; multiple importers allowed under ANVISA rules |
| Device types they name | Devices, SaMD, IVD; INMETRO/ANATEL; BPF | Already FDA-cleared or CE-marked devices; INMETRO/ANATEL/BGMP managed as carved-out third-party items on the public price page |
| Geography | Brazil | Published pricing in Mexico, Colombia, Brazil, Peru and Argentina; other markets quoted case by case; certified translations in-house |
| Trial-to-market | Not a published FIH CRO bridge | Same firm can run the FIH trial and hold the commercial registration |
bioaccess® market access is a different product. bioaccess® registers already FDA-cleared (510(k)/PMA) or CE-marked devices and holds them under contract — sanitary registration, registration holder / importer of record (in Colombia through its own Colombian entity; elsewhere with its local partner), and certified Spanish or Portuguese translations (sworn where Brazil and Argentina require it). Pricing is published for Mexico, Colombia, Brazil, Peru and Argentina; Chile and other markets are quoted case by case. The registration is held for the manufacturer’s benefit, with defined transfer provisions; it is not leverage. Pricing is two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card).
DOMO is a fair Brazil titular with import letters. bioaccess® is the operator when the same family must also be held in Mexico, Colombia, Argentina, Chile, or the rest of the published coverage — under one annual-fee shape, with the holder not used as leverage.
If the plan is one country and a homegrown titular is enough, hire the shop that actually publishes that job. If the plan is several LATAM labels under one holder who is not the distributor, start at bioaccess® market access or request a registration quote.