Brazil Custom-Made and Refurbished Devices: RDC 925/2024 and RDC 579/2021

1. Key takeaways

Custom-made devices and second-hand or refurbished devices in Brazil do not follow the ordinary notification or registration logic: the former are now governed by RDC 925/2024 and the latter by RDC 579/2021 — 2 dedicated rules that each provide exceptional arrangements. GRZAN’s judgment: the shared risk of the two categories lies not in whether to register, but in mistaking the inapplicability of the ordinary pathway for the absence of obligations. The registration prerequisite established by Article 12 of Lei 6.360/1976 and the prohibitions of Article 60(1) of RDC 751/2022 remain the baseline for judging the boundaries of any conduct involving these products.

2. Legal basis

• Manufacture, sale, import and use of custom-made and patient-matched devices — RDC nº 925/2024, resolution of September 19, 2024 (the replacement relationship and article details are secondhand — a practical estimate; defer to ANVISA publications; ANVISA’s official device page lists RDC 751/2022 and RDC 925/2024 side by side under orthopedic implants)
• Provisions on personalized medical devices — RDC nº 305/2019, resolution of September 24, 2019, published in DOU No. 186 of September 25, 2019, Section 1, p. 69 (the predecessor rule to RDC 925/2024)
• Provisions on second-hand or refurbished devices — RDC nº 579/2021, resolution of November 25, 2021, published in DOU No. 225 of December 1, 2021
• Requirements for the classification, notification and registration of medical devices and for labeling and instructions for use — RDC nº 751/2022, resolution of September 15, 2022 (Board meeting of September 14), published in DOU No. 180 of September 21, 2022 (Seção 1, p.172): Article 2(2), Article 2(3) (as amended by RDC nº 777/2023), Article 60(1)
• Basic Brazilian law on health products — Lei nº 6.360/1976, published September 23, 1976: Article 12, Article 10

3. Expert insights

Why do these two categories need dedicated legislation? GRZAN’s reading: the ordinary registration system rests on assumptions of batch production, fixed models, and traceability to a manufacturing unit. Custom-made devices are produced for an individual patient or an individual prescription, so the concept of a model does not hold; for second-hand or refurbished devices the original registration chain is already broken, and running them through registration again is logically unsound. The legislator therefore carved both out of the ordinary pathway with dedicated rules.

The first thing to see is that the custom-made rules have changed anchor. RDC 925/2024, resolved on September 19, 2024, governs the manufacture, sale, import, and use of custom-made (sob medida) and patient-matched devices; its predecessor was the personalized medical devices rule established by RDC 305/2019. Echoing the rework, RDC 777/2023 amended the exception wording pointed to by Article 2(3) of RDC 751/2022 to custom-made (sob medida) devices, aligning the master regulation and the dedicated rule on the same term. GRZAN cautions: the replacement relationship and article details of RDC 925/2024 remain secondhand sources at this point, and a check against the official text is required before project implementation (a practical estimate; defer to ANVISA publications).

The second is the red line for refurbished devices. Article 2(2) of RDC 751/2022 points second-hand or refurbished devices to RDC 579/2021; under that dedicated rule, second-hand or refurbished implantable devices must not be imported, must not be sold, and must not be donated. This is not a procedural problem to be navigated with explanatory documents; it is a prohibition, and procurement and donation plans should be rejected outright at project initiation.

The third is the confusion risk. Custom-made and refurbished are 2 entirely different pathways: the former serves individual patients, the latter serves the circulation of used equipment; the responsible entities, record requirements, and traceability logic all differ, and managing both with one internal process invites errors.

The fourth is that post-market obligations are not waived. Once either category enters the Brazilian market, the logic of technovigilance (Tecnovigilância) and field actions (Ação de Campo) still applies, and the responsible party under RDC 67/2009 and RDC 551/2021 remains the entity registered within Brazil — a foreign factory cannot discharge those duties itself.

4. Practical recommendations

First, make the applicability call early. The GRZAN regulatory team recommends determining, already at the commercial negotiation stage, whether the product is custom-made, patient-matched, second-hand or refurbished, or ordinary, and recording the basis in writing — this 1 conclusion determines the entire scope of downstream obligations.

Second, do not skip the import prerequisite. Where imports are involved, assess under Article 10 of Lei 6.360/1976 whether prior express consent from the health authority is required before arranging logistics, so goods do not arrive at port only to fail customs clearance.

Third, draw the red line for implantables. Second-hand or refurbished implantable devices must not enter import, sale, or donation; list the prohibition as a standalone clause in the internal compliance manual.

Fourth, make the record obligations real. Prescription and manufacturing records for custom-made and patient-matched devices, and provenance and reprocessing records for refurbished devices, should form a complete chain at the time of delivery.

Fifth, designate a responsible entity within Brazil. Technovigilance and field-action responses require a domestic entity, and this arrangement should be completed before the first delivery.

5. Verification checklist

• □ The product class has been determined as custom-made, patient-matched, second-hand or refurbished, or ordinary, with the basis archived in writing
• □ The applicable provisions and replacement relationship of RDC 925/2024 have undergone final verification on anvisalegis or the DOU (a practical estimate; defer to ANVISA publications)
• □ The applicable provisions of RDC 579/2021 have been finally verified, and the import, sale, and donation prohibition for second-hand or refurbished implantables is written into internal red lines
• □ The prior express consent requirement for imports has been assessed under Article 10 of Lei 6.360/1976
• □ The manufacturing, provenance, and reprocessing record chains for custom-made or refurbished devices are complete
• □ A responsible entity within Brazil has been designated, with technovigilance and field-action response mechanisms in place

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Affairs Team

GRZAN supports manufacturers entering the Brazilian market with ANVISA registration pathway and classification strategy services, including applicability assessment for custom-made and patient-matched devices under RDC 925/2024, refurbished-device compliance under RDC 579/2021, and post-market accountability structures that keep technovigilance and field actions answerable inside Brazil. To classify a special-category product correctly at the start, contact the GRZAN regulatory team at info@grzanglobal.com.