EU Authorized Representative for Brazil: RDC 751/2022, B-GMP and the Annex IX Gap
Brazil is the rare export market whose own rulebook was drafted to resemble Europe's. RDC 751/2022 gives ANVISA four risk classes and twenty-two classification rules applied by intended purpose, and ANVISA is one of five member authorities in the Medical Device Single Audit Program. That similarity is worth money when you build a European file, and it misleads badly if you assume any of it transfers. This page sets out precisely where the Brazilian route helps and where it stops.
Twenty-two classification rules in Brasília, twenty-two in Brussels
A Brazilian regulatory manager reading MDR Annex VIII usually has the same reaction: this looks familiar. It should. Annex I of RDC no. 751 of 15 September 2022 sets out twenty-two classification rules, applied by intended purpose, with the tie-breaker Europe uses — where several rules or sub-rules apply, the one giving the higher class wins (Art. 8, Paragraph 6). Software controlling a device takes that device’s class; accessories are classified separately. Each instruction has a counterpart in MDR Annex VIII, Chapter II.
The resemblance is useful: a Brazilian file already contains a reasoned classification argument rather than a bare product code, and the reasoning is the expensive part to invent later. What it does not mean is that the answer carries across. ANVISA counts to four — Class I low risk, Class II medium, Class III high, Class IV maximum (Art. 5) — and MDR counts I, IIa, IIb, III. Four boxes do not map onto four boxes. A Class II device in Brazil lands in MDR class IIa or IIb depending on which Annex VIII rule bites, and occasionally in class I. You re-run the rules; you do not translate the label.
Notificação and registro: what Articles 6 and 7 of RDC 751/2022 actually decide
Brazil splits market authorisation into two instruments, cleanly. "Medical devices classified in risk classes I and II are subject to notification." (RDC 751/2022, Art. 6) And "Medical devices classified in risk classes III and IV are subject to marketing authorization." (RDC 751/2022, Art. 7) The first is processed routinely, without technical analysis, within thirty days. The second is a reviewed dossier, valid for ten years and renewable (Art. 11).
The temptation is to read notificação as MDR self-declaration and registro as notified body certification. Resist it. MDR class I is not a filing at all: the manufacturer draws up technical documentation to Annexes II and III, signs an EU declaration of conformity under Article 19, affixes the CE mark and registers. No authority reviews anything. Conversely, a Brazilian Class II product that Annex VIII puts in class IIa needs a notified body, even though ANVISA never opened the file. The two systems disagree most sharply exactly where a Brazilian manufacturer feels safest.
The B-GMP certificate, and the inspection an MDSAP report replaces
Nothing in the Brazilian system carries more weight than Boas Práticas de Fabricação. RDC 751/2022 is explicit: "The granting of the marketing authorization is subject to the publication of the Good Manufacturing Practices Certificate issued by Anvisa." (RDC 751/2022, Art. 10, Paragraph 8) Maintaining either instrument is tied to continued B-GMP compliance under RDC no. 665 of 2022.
Brazil was a founding member of the Medical Device Single Audit Program, and ANVISA uses it in a documented way. On the agency’s own account, MDSAP audit reports may support regulatory decisions including issuance of the CBPF from the date the auditing organisation is recognised by RE, and the ANVISA inspection is waived where the report meets the MDSAP procedural requirements. The legal hook is the sole paragraph of Art. 4 of RDC no. 39/2013 as amended by RDC no. 15/2014, activated for MDSAP by RE no. 2.347/2015. ANVISA also states that the programme is voluntary: a manufacturer that does not join waits for the agency’s own inspection.
Where ANVISA’s seat at the MDSAP table stops being useful
The honest answer is that it stops at the notified body’s door. MDSAP has five member authorities — ANVISA, the TGA, Health Canada, Japan’s MHLW and PMDA, and the US FDA. The European Union is listed as an Official Observer, not a member. Observers do not accept audit reports; they watch.
Under MDR Annex IX, Chapter I, the manufacturer lodges an application for assessment of its quality management system with a notified body, and the notified body audits. There is no provision for substituting a report written by somebody else, however competent, however recognised in Brasília. What a mature MDSAP system gives you is readiness: management review, design control, CAPA, supplier control and post-market surveillance procedures that already survive external audit. The Annex IX audit will also ask for things MDSAP does not — an Article 15 person responsible for regulatory compliance, a post-market surveillance plan built to Annex III, and a clinical evaluation under Article 61 and Annex XIV that satisfies a reviewer rather than an auditor.
| What you hold | What it does in Brazil | What it does in the Union |
|---|---|---|
| MDSAP audit report | Replaces the ANVISA inspection for CBPF issuance, per RE 2.347/2015 | Nothing formally; preparation for an Annex IX, Chapter I audit, not a substitute |
| CBPF (B-GMP certificate) | Precondition for a registro under Art. 10, Paragraph 8 | No status. MDR knows Article 56 certificates, not GMP certificates |
| ANVISA registro or notificação | Authorises commercialisation in Brazil | No status; not evidence of conformity with the GSPRs |
| ISO 13485 certificate | Supports the licensing file | Presumption of conformity for what it covers; the notified body still audits |
Portuguese is a Union language. That helps less than you expect.
ANVISA requires forms, instructions for use and labelling models in Portuguese (Art. 10, Paragraph 9); other dossier documents may be in Portuguese, Spanish or English. Brazilian exporters therefore arrive with an advantage almost no other third-country manufacturer has: their language is an official language of the Union.
The advantage is narrower than it looks. MDR sets the obligation per market, not per language: "Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient." (MDR Art. 10(11)) Ship to Portugal and your existing pack is a starting point, subject to European Portuguese conventions and to Section 23 content your Brazilian label was never asked for. Ship to Germany, France or Poland and you translate from zero. The representative’s address is not decoration either: Annex I requires "if the manufacturer has its registered place of business outside the Union, the name of the authorised representative and address of the registered place of business of the authorised representative;" (MDR Annex I, Section 23.2(d)) on the label of every unit.
The mandate, the SRN and what a Brazilian manufacturer keeps
MDR Article 11(1) is the reason this page exists: "Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative." (MDR Art. 11(1)) The designation is a written mandate, effective at least for all devices of the same generic device group (Art. 11(2)).
What the mandate cannot do is move your obligations. "The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12)." (MDR Art. 11(4)) Risk management, technical documentation, the declaration of conformity, the quality system, post-market surveillance and labelling stay in your plant. What moves is the Union-facing side: holding documentation for competent authorities, answering them in their official language, and the registration duties. The sequence is short: sign the mandate, register for a single registration number, then apply to a notified body. We handle both Union-side steps, the Article 11 mandate and EUDAMED actor and device registration.
Answers for a Brazilian regulatory department
Our plant has a valid MDSAP certificate. Does that shorten the notified body audit?
It shortens your preparation, not the audit. A notified body performing an Annex IX, Chapter I assessment audits the quality management system itself and cannot rely on a report issued under a programme the Union only observes. Expect audit days scoped normally, and fewer major findings.
We hold a registro for a Class III device. Is that our MDR class III?
Not necessarily, and the assumption is expensive. Brazilian Class III and Class IV both sit under the registro instrument, while MDR class IIb and class III involve a notified body under different routes and different scrutiny. Re-run Annex VIII rule by rule and document the reasoning.
Can our Brazilian legal entity hold the mandate through a European subsidiary?
Only if that subsidiary is genuinely established in a Member State and accepts the mandate in writing. Article 11(5) then applies to it: where the manufacturer has not complied with Article 10, the representative is liable for defective devices jointly and severally with the manufacturer. Many Brazilian groups prefer that exposure outside the group.
Does ANVISA need to know we have appointed an EU representative?
No. The two systems do not talk to each other. Your Brazilian instrument and its B-GMP basis are unaffected by anything you do in Europe, and your EU file is assessed without reference to ANVISA. Budget them separately — our published class-based fees cover the Union side only.