bioaccess® registers your device in Mexico, Colombia, Brazil, Peru and Argentina. Where local law requires a local party, we act as registration holder (or, in Colombia, as your attorney-in-fact), importer of record (where applicable) and tecnovigilancia contact. You pay a one-time registration fee when the work happens, then a lower annual holder fee. No multi-year contract is required. All prices are in USD, exclude VAT and local taxes, and apply to new registrations of devices regulated as medical devices (IVDs, combination products and controlled-technology equipment are quoted case by case).
| Country (agency) | Class I / II | Class IIa / IIb | Class III / IV |
|---|---|---|---|
| Mexico (COFEPRIS) | $5,000 | $8,000 | $13,250 |
| Colombia (INVIMA) | $4,000 | $6,250 | $9,000 |
| Brazil (ANVISA) | $6,750 | $11,500 | $22,250 |
| Peru (DIGEMID) | $4,250 | $6,500 | $10,500 |
| Argentina (ANMAT) | $4,500 | $6,500 | $12,000 |
Classes follow each country's own rules; we confirm your class in writing before you sign; the agency's final determination controls. Mexico uses Classes I, II and III (the Class I/II column covers Mexico Class I; Mexico Class II uses the IIa/IIb column). Brazil uses Classes I–IV (I/II by notificação; III/IV by registro). Peru and Argentina use Classes I–IV: Class I uses the first column, Class II the second, and Classes III and IV the third. Colombia uses Classes I, IIa, IIb and III (I in the first column, IIa and IIb in the second, III in the third).
What one fee covers: - Mexico: one registro sanitario (one product; models and presentations COFEPRIS accepts under that registro). - Colombia: one registro sanitario, including the models INVIMA accepts under it. - Brazil: one notificação or registro, single product or one family of products as ANVISA accepts. - Peru: one registro sanitario. - Argentina: one ANMAT registration (PM), including the models ANMAT accepts under it. Additional registrations, or models the agency requires to be filed separately, are quoted separately.
Included: dossier gap review and adaptation to local requirements; submission and agency follow-up through decision, including responses to agency questions; official government filing fees for the initial registration up to the cap below; certified/sworn translations up to the page cap below; and the first 12 months of holder / apoderado service after approval.
| Country | Annual holder fee |
|---|---|
| Mexico | $4,500 |
| Colombia (apoderado; you hold the registration) | $3,900 |
| Brazil, Class I/II | $6,000 |
| Brazil, Class III/IV | $7,500 |
| Peru | $4,200 |
| Argentina | $4,200 |
Included: acting as local registration holder / legal representative where we serve in that role; importer of record where applicable; tecnovigilancia reporting duties (receiving complaints, adverse-event and periodic reports to the agency, relaying field-safety notices you issue); routine agency correspondence; and maintaining the registration file.
Colombia: you keep the title. You may hold the INVIMA registration in your own name (titular) without a Colombian entity. bioaccess® designates a Colombia-based attorney-in-fact (apoderado) to file and manage the registration before INVIMA for you, and the Colombia annual fee covers that role. A Colombia-domiciled importer with an INVIMA storage certificate (CCAA) is still required for imports and shares post-market (tecnovigilancia) obligations. We can work with your distributor or help arrange one. Importer services are quoted separately. Unlike Colombia, Mexico, Brazil, Peru and Argentina require a locally established registration holder.
Technovigilance included (Mexico & Brazil): the annual holder fee for Mexico (COFEPRIS) and Brazil (ANVISA) includes technovigilance: adverse-event reporting to the agency, field safety actions (notifying the agency and relaying the field-safety notices you issue; executing a recall is quoted separately), and agency correspondence.
Government fees. Government fees are separate from bioaccess® professional fees and are updated by each agency every year. We include them up to the official tariff for the initial registration in force on 14 October 2026 (COFEPRIS: Ley Federal de Derechos art. 195-A, 2026; INVIMA: Manual Tarifario 2026 (Resolución 2025067543, as modified), codes 3003 and 3004; ANVISA: TFVS, which depends on the declared company size of the Brazilian registration holder (bioaccess®'s declared size applies where we are holder); DIGEMID: TUPA; ANMAT: tasas). Included caps per registration: Mexico and Colombia, the full official fee for your class in local currency as in force on that date (we absorb FX at our billing rate on the invoice date); Brazil, up to USD 350 (Class I/II) and USD 1,600 (Class III/IV); Peru, up to USD 690; Argentina, up to USD 860. Any amount above the cap, including tariff increases after that date, FX moves on the Brazil, Peru and Argentina caps, or higher fees from company-size rules, is billed at cost with no markup.
Translations. Certified/sworn translations included up to 150 pages (Class I/II), 250 pages (Class IIa/IIb) and 400 pages (Class III/IV) per registration. Pages beyond the cap are billed at cost.
Not included: - Brazil BGMP (ANVISA GMP certification), INMETRO certification and ANATEL homologation. - Mexican testing, NOM certification and any third-party or local testing. - Clinical evidence work, clinical evaluation review and clinical studies. - Registration renewals and their government fees, and post-approval changes or modifications (quoted when needed). - Recalls, field corrective actions, product returns and destruction. The annual fee covers tecnovigilancia reporting; if a field action is needed we will carry out the steps the law requires of the local holder and bill the work at our then-current rates, with you bearing the costs. - Import duties, customs brokerage, freight, warehousing and per-shipment importation costs. - Legalizations/apostilles of manufacturer documents and certificates of free sale. - Classification disputes, appeals or re-filings after a refusal attributable to the device, its documentation or data you supply.
10% off registration fees when you register in 3 or 4 of these countries; 15% off when you register in all 5. Start with any country. The discount applies to the registration fee of each country once the qualifying number of countries is under contract within 12 months of your first agreement; earlier invoices are not re-priced.
Trial-to-Market Bridge: clinical-trial clients save 20% on registration fees.
You can end the holder service with 60 days' written notice at the end of any annual holder term. If you move a registration to another holder, we charge no transfer fee of our own, sign the documents you need, and cooperate in good faith until the transfer is complete. We remain holder, and the annual fee continues pro rata, until the agency approves the transfer, provided your account is current. Government fees and the new holder's costs are yours. Transfers are not free or instant: every transfer needs an agency filing and approval and can take months, and in Argentina the new holder generally needs its own registration. The country annex to your agreement sets out each step.
Many providers quote case by case, or charge a flat annual fee that excludes government fees and certified translations and requires a multi-year term.¹ We publish our prices, include initial government fees and translations up to a stated cap, and don't require a multi-year contract.
¹ Based on our review in October 2026 of publicly available pricing and service information from 7 providers, modelled on a typical 3-year subscription. We did not review every provider; terms and totals vary by provider, device and country.
Chile: quoted case by case. Not part of the fixed-price plan.
This page is for information only and is not an offer; the written agreement governs. Prices are valid for agreements signed by 31 March 2027. Final scope and price are set in your written agreement.