Pro Health is a regulatory consultancy in Brasília (SIA, Guará, Distrito Federal) that specializes in ANVISA work for medical devices. Among its published services is “Hospedagem de registros”, an ANVISA registration hosting service for manufacturers. The service list is at pro-health.net.br/solucoes (retrieved 28 October 2026). This article uses only what Pro Health publishes, then compares it with the multi-country market access offer from bioaccess®.
What Pro Health publishes
Pro Health says it offers complete infrastructure, with the licenses and authorizations needed to host your registration and act as your regulatory legal representative in Brazil. Its argument is the right one: naming a registration holder that is not running the commercial distribution keeps the manufacturer in control of its Brazilian registrations, independent of the distribution chain, so it can appoint several distributors without losing regulatory control of its products.
Around that hosting service, the page lists:
- Registration and notification of medical devices with ANVISA, covering equipment, implantable and non-implantable materials and IVDs, risk classes I to IV.
- Post-registration change assessment, deciding whether a design change needs an ANVISA filing.
- Sanitary licensing support for manufacturers, importers, distributors and warehouses.
- Good Manufacturing Practice (BPF) certification support, including pre-audits and local support during ANVISA inspections.
- Regulatory due diligence for acquisitions of medical device companies.
We found no public price; the site says engagements are tailored to each project. Pro Health publishes Brazil only.
That pitch fits Brazil. A foreign manufacturer without a Brazilian entity needs a local detentor do registro (Brazil Registration Holder), and a holder that is not your distributor lets you change or add importers without losing the registration. As the bioaccess® Brazil ANVISA page explains, the holder also answers ANVISA for tecnovigilancia, so who holds the registration is a long-term decision.
Pro Health vs bioaccess®
| Dimension | Pro Health (Brazil) | bioaccess® |
|---|---|---|
| Public product | ANVISA registration hosting and regulatory legal representation, plus device registration, post-registration changes, company licensing, BPF support and due diligence | Medical device registration and market access across Latin America, with holder, importer of record where applicable, and tecnovigilancia roles in the published-price countries |
| Geography | Brazil | Mexico, Colombia, Brazil, Peru and Argentina at published prices; Chile and other Latin American markets quoted case by case |
| Public pricing | None published; tailored per project | Brazil published: one-time registration fee of $6,750 (Class I/II) or $22,250 (Class III/IV), then an annual holder fee from year 2 of $6,000 (Class I/II) or $7,500 (Class III/IV). Published two-part pricing also for Mexico, Colombia, Peru and Argentina |
| Tecnovigilancia | Not itemized on the service page | Included in the Brazil annual holder fee: adverse-event reporting to ANVISA, field safety actions and agency correspondence |
| Clinical trials | None published | bioaccess® runs first-in-human trials in Latin America and then registers the device |
Where each one fits
If Brazil is the only market on the plan and an independent ANVISA holder with BPF and inspection support is the whole job, Pro Health’s published offer covers it, and it makes the right point about keeping the registration away from your distributor.
bioaccess® is a different product. It runs first-in-human trials and then registers devices across Latin America. In Brazil, bioaccess® acts as your neutral Brazil Registration Holder under its contract with you, working with its local partner, and the prices are published on the LATAM registration rate card. The registration fee includes initial government fees and certified or sworn translations up to a stated cap; Brazil BGMP, INMETRO and ANATEL are quoted separately. Mexico, Colombia, Peru and Argentina follow the same two-part model, and other markets are quoted case by case.
One country and a local holder is enough? Hire the shop that publishes that job. Several LATAM labels under one partner who is not your distributor? Start at bioaccess® market access or request a registration quote.
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