The legal duties of a Brazilian registration holder

1. Key takeaways

A Brazilian registration holder is not a mailing address. The holder must, at a minimum, keep the technical dossier, be named on the label and answer vigilance events, three statutory duties that cannot be split away from the role. Where death or a serious public health threat occurs inside Brazil, the event must be reported to Notivisa within 72 hours of becoming aware of it. Treating the holder role as a purely nominal appointment is the most expensive misunderstanding in Brazilian projects. When GRZAN assists clients in selecting a holder, the first screening criterion has never been price; it is whether someone genuinely can carry these three duties through the whole life of the registration.

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 46, item I, Article 47 and Article 56
• Technical Vigilance Provisions — RDC No. 67/2009, published on December 21, 2009 (DOU of December 23, 2009); Article 3, sole paragraph, Article 4, Article 8 and Article 10
• Execution and Notification of Field Actions — RDC No. 551/2021, published on August 30, 2021; in full
• Operating conditions for companies subject to health licensing — Decreto No. 8.077/2013, signed on August 14, 2013, published in the DOU on August 15, 2013 (Seção 1, p.18) and in force as of that date (Article 26); Article 15, §1 (registration-holding companies, manufacturers or importers must ensure and maintain product quality, safety and effectiveness up to the final consumer), Article 15, §2 (joint liability of the parties across the chain from production to consumption), Article 16, sole paragraph (adverse events and technical complaints must be reported to ANVISA), Article 25 (revocation of Decreto No. 79.094/1977 and Decreto No. 3.961/2001)
• National Health Surveillance System and the Creation of ANVISA — Lei No. 9.782/1999, published on January 26, 1999; Article 7 (ANVISA powers, including granting product registrations, issuing and cancelling good manufacturing practice certificates, and charging health surveillance fees), Article 8, §1, item VI (medical devices and materials for medical use are controlled products) [practical estimate, subject to what ANVISA publishes]

3. Expert insights

The GRZAN view: read together, these provisions close the loop of dossier in one hand, name on the label and an accountable person for every event. RDC 67/2009, in Article 3, sole paragraph, writes the registration holder directly into the text as the legally responsible party for the products under its name; RDC 751/2022, in Article 56, requires the notification holder to keep the technical dossier; and Article 47 requires the label to carry the holder’s name and address together with the name of the technical responsible person. Each provision corroborates the others, and none of them allows the holder to stand aside from the product once the paperwork is signed.

The second point: the value of a duty list is that it doubles as the negotiation baseline at contracting. Third-party holder service providers often describe their scope as filing on behalf of the manufacturer, but vigilance response and field actions cannot be outsourced away. RDC 551/2021 makes the distribution and use chain jointly responsible for the effectiveness of field actions, and the responsibility still lands on the holder in the end; signing a service agreement does not release anyone from it.

Third, the deadlines are the most frequently underestimated element. For death, serious public health threat or counterfeiting occurring in Brazil, the deadline is 72 hours; for comparable events occurring abroad, 10 calendar days; for other verified serious adverse events, 10 calendar days; and for technical complaints that may lead to a serious adverse event, 30 calendar days. A holder without Portuguese-language response capability will watch those deadlines expire in a chain of forwarded emails, and no explanation afterwards restores the compliance position.

The fourth point concerns the exemption clause. Article 10 does provide exemptions for events arising exclusively from the patient’s own disease or from use after expiry, among others, but the exemption does not apply where a serious public health threat is involved. The GRZAN default position for clients is not to self-assess exemptions readily: the cost of reporting first and withdrawing later is far lower than the cost of a missed report, both in regulatory terms and in the scrutiny that follows.

The fifth point concerns scope. The technical vigilance rules apply to registration holders of health products that have an establishment in Brazil. A foreign manufacturer cannot keep the responsibility on its own side through a power of attorney alone; responsibility is bound to the registration, and whoever holds the registration carries the risk with it.

The sixth point comes from the decree level. Decreto 8.077/2013, in Article 15, §2, chains responsibility across production, distribution, import, storage, transport, display for sale and use into a single joint-liability chain, and the provision sits inside Article 15, which governs products exempt from registration yet still regulated. GRZAN’s working rule when mapping responsibilities is therefore: exemption reduces the registration obligation, not the chain liability, and a holder cannot exit vigilance and traceability by arguing that the product never needed registration in the first place. The same article, in §1, makes the duty even more concrete: registration-holding companies, manufacturers and importers must ensure and maintain the quality, safety and effectiveness of the product, with the endpoint being the final consumer rather than the moment the goods leave the warehouse.

The seventh point also comes from the decree: Article 16, sole paragraph, requires adverse events and technical complaints to be reported to ANVISA, and failure to report constitutes a health infraction. This lifts the reporting duty from an industry regulation up to the decree itself. The duty is not a technical requirement ANVISA added through a resolution at its own discretion; it is imposed directly by the decree, and the 72 hours, 10 calendar days and 30 calendar days of RDC 67/2009 merely slice that duty into clocks that can be audited.

4. Practical recommendations

GRZAN recommends writing vigilance response into the holder agreement as an enforceable service standard: who receives complaints, who forwards them within how many hours, who files with Notivisa in Portuguese, and who follows up on ANVISA supplementary queries. All four steps should be assigned to named parties, not left to be settled between the parties as circumstances arise. Vague allocation is precisely what fails under deadline pressure.

At the same time, confirm before the label is finalized that the technical responsible person’s name is printed on it, avoiding a forced relabel after market entry. For structures in which a distributor holds the registration, GRZAN recommends agreeing in the contract on response times for the manufacturer’s technical support, because the dossier sits with the holder while the original data sits at the factory, and the distance between the two must be bridged by agreement rather than goodwill.

In addition, run a quarterly dossier retrieval drill: pick one model at random and require the holder to produce the complete technical dossier within three business days. If it cannot be produced, the dossier exists only on paper. This duty list should also be reviewed every six months, because regulatory amendments and changes in the product portfolio both alter its scope; it is not something fixed once the agreement is signed and filed away.

Finally, distinguish exemption from registration from exemption from regulation: Decreto 8.077/2013, in Article 15, makes clear that products exempt from registration remain subject to regulation. Even where a product follows the notification or exemption pathway, the holder’s dossier-keeping and vigilance duties do not disappear with it.

5. Verification checklist

• □ Does the holder have Portuguese-language vigilance response capability
• □ Is the technical dossier kept by the holder and retrievable on demand
• □ Does the label state the holder’s name and address and the technical responsible person’s name
• □ Do agreements with third parties cover the duty to cooperate in field actions
• □ Are registration-exempt or notification-pathway products included in the same vigilance and traceability process

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.