Can medical device system accessories be sold separately in Latin America? - Wiselink Group-A More Controllable, Stable, and Future-Oriented Material Direction

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Can medical device system accessories be sold separately in Latin America?

Time：2026-10-15 13:48:19

Many medical device manufacturers expanding into Latin American markets often have the same question: can accessories/spare parts included in a fully registered equipment system be exported and sold independently? Brazil ANVISA and Mexico COFEPRIS have clear regulatory definitions. Independent sales are not permitted simply by intention; compliance boundaries must be clarified.

一、Mexico: Official Definition of Medical Device Accessories

Mexico’s health registration regulations clearly define medical device accessories: A medical device accessory refers to an item that is not a medical device by itself, but is intended by the manufacturer to be used together with one or more medical devices. Its function is to ensure the medical device performs its intended use, or directly and specifically fulfills the medical function of the medical device. Such accessories may be supplied packaged together with the medical device, or supplied separately as accessories designed exclusively for use with the main device.

Mexico’s regulations permit separate supply and sales of accessories subject to strict prerequisites：

The accessory itself is not an independent medical device;
Its intended design use is only for matching specified main equipment and cannot exert medical effects independently;
It can only be used as a supporting accessory for the main device.

二、Brazil: Rules for Separate Sales of System / Kit Spare Parts

Articles 11 and 12 of Brazil ANVISA RDC 556/2021 specifically govern the independent commercialization of components for systems and device kits.

（一）Article 11

During the declaration / registration process of a system or kit, commercial specifications cannot be modified by deleting components or materials.

For spare part replacement purposes, system components may be marketed and sold separately, but exclusively for use with that system.
Labels and instructions for use of system spare parts must indicate: I. The trade name of the system and the name of the spare part, consistent with the information declared in the registration dossier; II. Mandatory text marking: Spare part, for use exclusively with this system.

（二）Article 12

For spare part replacement purposes, consumables within device kits dedicated to specific surgical procedures may be marketed and sold separately, but exclusively for use with that kit.

Labels and instructions for use of separately sold device kit spare parts must indicate:

I. The trade name of the kit and the name of the spare part, consistent with the information declared in the registration dossier;

II. Mandatory text marking: Spare part, for use exclusively with this device kit.

Summary of Brazil Regulatory Core：Brazil permits separate sales of system/kit spare parts, limited to replacement and maintenance scenarios, and they cannot be sold as standalone products.Mandatory requirements apply to product labels and instructions for use, and all required text markings are indispensable.

三、Comparison of Separate Sales Rules for Accessories: Brazil vs Mexico

Country	Regulatory Core	Applicable Scenario	Key Restrictions	Label Requirements
Mexico COFEPRIS	Accessories are not medical devices on their own and may be supplied separately	Used with matching main equipment	For specified main equipment only; cannot be used independently	Mark in accordance with registration information, clearly identified as supporting accessory for main unit
Brazil ANVISA RDC556/2021	System/kit spare parts may be independently commercialized	Spare part replacement & maintenance	Only compatible with original system/kit; cannot be sold as new standalone products	Mandatory marking: Spare part, for use exclusively with this system/kit; names consistent with registration dossier

四、Practical Reminders for Export Enterprises

Distinguish between accessories and independent medical devices：If an accessory can achieve medical functions on its own when taken separately, it qualifies as an independent medical device and cannot fall under the separate accessory sales rule. It requires independent registration.

Strictly prohibit expanding sales scope in Brazil：Brazilian spare parts are only for replacement and maintenance and cannot be sold to users outside the corresponding system. Missing label text markings will directly result in non-compliance.

Advance planning at registration stage：Enterprises planning to sell spare parts separately in the future must include the spare part list, names and intended uses in the registration dossier during system application. Otherwise, separate marketing will not be allowed afterwards.

五、Conclusion

Brazil and Mexico, two core Latin American markets, both allow separate sales of accessories, yet they follow fundamentally different logics. Mexico focuses on the definition of accessories, while Brazil centers on spare part replacement. Many enterprises encounter compliance pitfalls due to confusion over the boundaries between spare parts, accessories and standalone medical devices, or omission of mandatory label statements. If your business plans to enter Brazil and Mexico markets, you need to plan the commercialization path of accessories at the registration stage to avoid sales blockages later.For further enquiries, please consult Wiselink.

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