Transferring Brazilian registration ownership under RDC 903/2024

1. Key takeaways

Ownership of a Brazilian registration cannot simply be handed over by an agreement between the parties: RDC 903/2024, in Article 26, requires the transferee’s transfer application and the transferor’s cancellation application to be filed simultaneously, within a window of 180 days, after which ANVISA rejects the request outright. Notification products and products exempt from registration cannot be transferred at all and must be re-filed. GRZAN suggests companies memorize one sentence: after a transfer the registration number changes, but the validity does not. Everything else in the procedure follows from that pairing of continuity and formality.

2. Legal basis

• Transfer of ownership and cancellation of product registrations — RDC No. 903/2024, resolution of September 6, 2024, published in the DOU on September 9, 2024 (issue 174, Section 1, p.85) and in force as of that same date (Article 48); Articles 6, 26, 27, 28, 29, 38, 39, 40, 45 and 47
• 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; Articles 6, 7 and 11
• Operating conditions for companies subject to health licensing — Decreto No. 8.077/2013, of August 14, 2013; Article 2

3. Expert insights

The GRZAN view: RDC 903/2024 ties the transfer to a corporate act or a commercial act — merger, spin-off, incorporation, succession, or the transfer of assets or asset portfolios. A purely nominal change of name on the certificate, unsupported by a real transaction, has no administrative entry point at all, however well drafted the underlying paperwork may be.

The second point is the start date of the window, and it is where the arithmetic most often goes wrong. Article 26, §2, counts corporate acts from the date of registration at the competent commercial registry, commercial acts from the date the asset transfer contract is signed, and MERCOSUR representation from the termination of the contract between the representative and the foreign represented company. Article 26, §1, then makes clear that an application filed late is rejected outright by ANVISA; it is not an opportunity to cure the defect later.

The third point is the largest practical risk: the procedure requires the original holder to sign and cooperate, and where it does not, ANVISA does not intervene administratively. The company is left with the Brazilian courts or a fresh registration, and in the meantime import and sales may be interrupted. GRZAN therefore recommends treating the transfer as part of the transaction negotiation itself, not as an administrative chore to be cleaned up after closing.

The fourth point settles Article 28, which can now be stated firmly from the official text: notification products and products exempt from registration do not fall within ownership transfer, and the successor company must re-file the notification or re-submit the application. Secondary Chinese sources often say Brazilian registrations can be transferred as a whole; for Class I and II products that is wrong. Replacing the holder of a low-risk product portfolio is in substance a fresh notification process and needs its own lead time.

The fifth point concerns legacy products. Article 27 provides that cadastro-type products are equivalent to registro-type products and may be transferred without opening a separate pathway. GRZAN notes here that the official English translation renders this as registered products being equivalent to registered products, a translation flaw, and the Portuguese original should prevail. Article 47 simultaneously revokes RDC 102/2016, RDC 118/2016, RDC 233/2018 and Article 13 of RDC 438/2020; any secondary source still citing RDC 102/2016 for the current transfer rules is outdated.

The sixth point concerns the consequences of the transfer: Article 29 provides that the transfer results in the simultaneous publication in the DOU of the new registration number and the cancellation of the old one, with the characteristics of the product and its registration validity unchanged, and label redesign and data updates must keep pace. Combined with Article 45, the specific cancellation and transfer resolutions take effect 90 days after publication, so the publication date and the effective date are two distinct milestones that must both be tracked.

The seventh point is the easiest to overlook: Article 6 provides that from the date the corporate or commercial act takes effect, the successor company universally succeeds to the rights and obligations of the original company, including compliance deadline obligations and any measures restricting product circulation already imposed. A transfer is not just a change of name on a certificate; unexpired obligations and existing restrictions travel with it.

The eighth point supplies the basis for keeping goods moving during the transition. Article 38 provides that before ANVISA decides on the corporate regularization, the successor company may import under the transferor’s AFE, provided it submits a declaration of the transaction to the health authority at the point of clearance. Article 39 places responsibility for finished-goods inventory before completion of the transfer on the successor company, whose imports must carry an authorization declaration issued by the transferor, and this does not release the transferor from joint liability for acts prior to the transaction. Article 40 allows finished-goods inventory produced before the resolution takes effect to be consumed within 180 days.

4. Practical recommendations

Agree in the contract that the original holder signs the transfer documents within a stated number of days of a written request, with delay treated as breach and damages attached; and that supply is not interrupted during the handover period, so the counterparty cannot use supply as leverage to delay signing. For reorganizations inside multinational groups, prepare the transaction documents on both the overseas and the Brazilian sides simultaneously, so the commercial act is evidenced in both places when the filings demand it.

Manage three dates separately in the schedule: the start date, whether the registry date or the contract signing date; the deadline for filing both applications, 180 days after the start date; and the effective date of the resolution, 90 days after publication. For Class I and II products, schedule re-filing directly; for Class III and IV, first confirm that the transaction documents can support the characterization as a commercial act, then start the double filing.

For transitional imports, prepare the transaction declaration and the transferor-issued authorization declaration under Articles 38 and 39 in advance, and write the inventory consumption window of Article 40 into the supply plan as 180 days rather than an informal target that procurement may quietly ignore.

Finally, keep a complete copy of the registration archive, including the original submission and every amendment record. If the transfer negotiation collapses, that archive is what makes a fast re-filing possible, and its versions should match what ANVISA holds. GRZAN treats this archive as standard deliverable in every transfer engagement.

5. Verification checklist

• □ Are corporate or commercial act documents supporting the transfer available, with the start date fixed
• □ Are the transferee’s transfer application and the transferor’s cancellation application ready for simultaneous filing within 180 days
• □ Is the product a notification product, a registration-exempt product or a registered product (the first two cannot be transferred)
• □ Has a legacy cadastro been handled as equivalent to a registro
• □ Are the transaction declaration and the transferor’s authorization declaration ready for transitional imports
• □ Are the publication date and the effective date of the cancellation and transfer resolutions (90 days after publication) both recorded
• □ Does the agreement state the original holder’s duty to sign and the liability for breach

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.