Foreign manufacturers cannot hold a Brazilian ANVISA registration directly

1. Key takeaways

A foreign manufacturer cannot hold a Brazilian ANVISA market authorization or notification in its own name. RDC 751/2022, in Article 4, item VIII, defines the holder as “legal, public, or private entity, manufacturer, or importer, responsible for the medical device in Brazilian territory, which holds the grant of commercialization of medical device, issued by Anvisa”. What actually keeps the overseas factory outside the gate, however, sits one level below: Decreto 8.077/2013, in Article 2, together with RDC 16/2014, requires that regulated activities be carried out by a legal entity holding a CNPJ and established in Brazil, under ANVISA authorization. For a Chinese manufacturer entering the Brazilian market, the first step is therefore not preparing the technical dossier but landing a legal entity inside Brazil. Until that entity exists and holds the proper authorization, no amount of documentation quality will move an application forward.

One widespread misconception also deserves correction. The term BRH is nothing more than an industry jargon, derived from the initials of an English phrase, and the full text of RDC 751/2022 never uses it. The statutory terms are detentor de registro and detentor de notificação, and the official English translation renders them as holder. GRZAN uses the statutory terms in all external documents, precisely so that partners do not walk away believing that Brazilian law actually recognizes a distinct entity type called BRH. Precision here is not pedantry: contracts, registrations and correspondence should quote the terminology the regulator itself uses.

2. Legal basis

• Classification, Notification and Registration of Medical Devices and the Requirements for Labels and Instructions for Use — RDC No. 751/2022, resolution of September 15, 2022, in force as of March 1, 2023 (Article 67); Article 4, item VIII, Articles 6, 7 and 11
• Operating conditions for companies subject to health licensing — Decreto No. 8.077/2013, of August 14, 2013; Article 2, Article 3 and Article 7 [practical estimate, subject to what ANVISA publishes]
• Standards for applications for operating authorization and special authorization — RDC No. 16/2014, published on April 1, 2014; Article 3

3. Expert insights

The GRZAN view is that the most common misreading of Article 4, item VIII lies precisely in the phrase in Brazilian territory. The official English text reads “legal, public, or private entity, manufacturer, or importer, responsible for the medical device in Brazilian territory, which holds the grant of commercialization of medical device, issued by Anvisa”. That phrase qualifies responsibility for the device; it does not require the entity itself to be established in Brazil. Reading it as a domicile requirement leads to the opposite conclusion, namely that a foreign manufacturer could hold its own registration once it sets up a Brazilian entity, and this misreading is remarkably common in secondary commentary. Correcting it is, in itself, one of the values of this article.

The genuine threshold on entity status has a different source. Decreto 8.077/2013, in Article 2, requires regulated activities to be performed by a legal entity established in Brazil, holding a CNPJ, with ANVISA authorization, and RDC 16/2014, in Article 3, grants the operating authorization activity by activity, including import. An application supported only by an overseas business licence will be turned back at the entity-status screening stage, before the merits of the technical file are ever discussed.

The second point is that holding and importing can be separated. The definition allows an importer to act as the holder, and it also allows a holder that does not import on its own account; but whichever party actually performs the import must hold an operating authorization that covers the import activity. GRZAN has seen projects in which the manufacturer signed both roles to the same distributor, only to discover at exit that the registration and the goods were tied to one counterparty with no clean way apart.

Third, the law requires only that the holder be a legal entity established in Brazil. Whether that role is filled by a wholly owned subsidiary, a distributor or an independent third party is a commercial choice, not a statutory one; what the choice determines is the cost of exit, not whether the arrangement is compliant. Under the very same provisions, the compliance threshold for all three structures is identical, which is why the decision deserves a business analysis rather than a regulatory one.

The fourth point is unrelated to any single document and entirely related to time: once a holder structure is chosen, it shapes the signature chain for every subsequent amendment, every transfer and every vigilance response. GRZAN recommends placing the structure decision after product classification but before dossier preparation, because classification determines the submission pathway while the structure determines who signs. Deciding in that order avoids rework and keeps both tracks aligned.

4. Practical recommendations

GRZAN recommends drawing a role map at the project-initiation stage: who holds the registration, who holds the operating authorization, who imports and who answers vigilance events. The four roles can be combined or split, but every additional role adds a set of contractual clauses, and every clause should state the remedy for breach. Leaving any of the four roles informal is the most frequent source of later disputes, because Brazilian administrative procedures will not force an unwilling counterparty to cooperate.

For Chinese manufacturers that have already signed exclusive agreements with a distributor, the recommendation is to add dedicated clauses on registration ownership, the duty to cooperate in amendments and transfers, and liability for refusal to cooperate, because Brazilian administrative procedure will not compel the original holder to sign. The registration is valid for 10 years, and the cost of changing channels during that period should be priced into the original quotation rather than calculated only when relations have already broken down. A clause negotiated at signing is cheap; the same protection attempted later is expensive and uncertain.

It is also advisable to run a worst-case exercise once: assume the channel negotiation collapses, and ask whether the registration can be recovered under the existing structure, how long that would take, and whether supply would be interrupted in the meantime. The conclusions of such an exercise usually say more about whether the structure is right than any contract clause does. In Brazil, the one-time investment in sound structure design is normally far below the cost of supply interruption caused by one failed transfer, and this is the standing warning GRZAN gives to first-time market entrants.

5. Verification checklist

• □ Is the proposed holder a legal entity validly established in Brazil
• □ Does the agreement state registration ownership and the duty to cooperate in transfers
• □ Does the operating authorization of the actual importer cover the import activity
• □ Do external documents consistently use the statutory terms, avoiding the ambiguity of BRH

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Team

GRZAN supports manufacturers entering the Brazilian market across the full holder and import chain: holder-structure design, AFE and operating authorization planning, importer qualification, vigilance readiness and official fee budgeting. For tailored support on Brazilian license holders, import qualifications and fee budgets, contact info@grzanglobal.com.