AFE exemption for component imports under RDC 939/2024

1. Key takeaways

The dividing line is whether the part holds a registration of its own: components without their own registration may be imported free of the AFE, while accessories already registered separately under RDC 751/2022 or RDC 830/2023 are treated as finished devices, and their importer must hold an AFE — under RDC 939/2024, applicable as of December 4, 2024. This rule lifts the spare-parts supply chain out of the compliance cost of finished-device import, and it matters most for companies whose competitive strength lies in installed equipment fleets and service response.

2. Legal basis

• Operating authorization rules for the import of medical device parts and accessories — RDC No. 939/2024, the resolution was adopted on November 14, 2024 (as recorded in the notification G/TBT/N/BRA/1545/Add.1 submitted to the WTO by the Brazilian delegation), and applies as of December 4, 2024; the DOU issue and page references and the entry-into-force date were not obtained this round, subject to what ANVISA publishes. The resolution governs the operating authorization of bonded-warehouse storage entities and importers and the application and exemption criteria for the special operating authorization; the exemption for medical device component imports applies accordingly
• 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 2, §9, Article 2, §10, Article 2, §11, Article 4, item VIII, Articles 6 and 7
• In Vitro Diagnostic Medical Devices — RDC No. 830/2023, published in the DOU on December 11, 2023, in force as of June 1, 2024; Article 12

3. Expert insights

The GRZAN view: what this rule really changes is the after-sales and repair scenario. Spare parts, loose components and repair items used to be handled wholesale as finished devices, forcing the importer to secure an operating authorization first; now components without their own registration are carved out, the cost structure of the repair-parts supply chain shifts accordingly, and local stocking for after-sales response becomes materially easier to organize.

The second point is that the risk sits in classification self-certification. Once a company obtains a registration for a given item, that item changes from a component into a finished device and the exemption immediately falls away. GRZAN recommends flagging, in the product master data, whether each item is separately registered, and re-checking that flag before customs clearance, rather than leaving the judgment to the customs broker at the counter on the day the goods arrive.

An even earlier check comes first: whether an accessory needs its own registration at all should be assessed against the three situations exempt from notification or registration in RDC 751/2022, Article 2, §§9, 10 and 11 — combinations of several approved devices each retaining its original packaging intact; accessories made by the manufacturer specifically for its approved devices and covered by their technical documentation; and new accessories that can be brought within the original notification or the original registration. Meeting any one of these means no separate registration is needed, and the item therefore does not fall on the side of RDC 939/2024 that requires an operating authorization.

Third, the storage requirement in a bonded warehouse, meaning a warehouse under special customs supervision, is not optional. Even where the importer is exempt from the AFE, the storage conditions must still be met. What is exempted is the operating authorization of the company, not health regulation itself; customs and health surveillance are two separate lines, and neither may be left empty.

The fourth point concerns the allocation of responsibility. Although components are exempt from the AFE, once they are used in assembly or repair and flow to the end market, the registration and vigilance responsibility for the finished device remains with the holder. GRZAN cautions clients not to misread the component exemption as an exemption for the entire product chain.

The fifth point addresses business model. If the Brazilian business is built around equipment plus consumables, the consumables normally carry their own registrations and still require full import qualification; only pure repair parts and loose components fall on the exemption side. The two categories should be managed separately, because mixing them in a single import list is the easiest way to get the treatment of one of them wrong.

4. Practical recommendations

Build a decision table at the material level: item number, whether registered, applicable rule, whether an operating authorization is required, and warehouse type for storage. The table should be updated in step with registration changes rather than rebuilt once a year, and it should be maintained by the regulatory function rather than procurement. Each row should also record the applicable regulatory reference for every category, so that the basis can be explained on the spot during customs or health inspections; GRZAN recommends that the regulatory function review the table monthly, so it does not silently expire after a registration status changes.

At the same time, remember that an AFE exemption does not open a way around Article 60, §1, of RDC 751/2022: finished devices may still not be imported, displayed for sale or delivered to consumption before publication in the DOU. The two rules cannot offset each other, and importing finished goods under the label of components is not a workaround anyone should attempt.

Before importing spare parts, confirm availability and storage conditions with the bonded warehouse operator and file the warehouse qualification documents in the supplier archive, so the goods do not arrive at port with nowhere compliant to be stored. For companies with large installed fleets and many part categories, the exemption decision should also be written into a standard operating procedure, so procurement and logistics execute one shared rule instead of asking the question afresh every time.

5. Verification checklist

• □ Has every imported item been confirmed as holding or not holding its own registration
• □ Are components imported free of the AFE stored in a compliant bonded warehouse
• □ Are separately registered accessories handled by an importer holding an AFE
• □ Is the decision table updated in step with registration changes

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.