Exempted Medical Equipment under NT 37 Annex 2 in Guatemala

1. Key takeaways

A list of equipment exempt from registration does exist in Guatemala: Annex 2 of NT 37 Versión 5-2016, titled EQUIPO MEDICO QUE NO REQUIERE INSCRIPCION (medical equipment that does not require registration). The list covers categories such as foldable crutches, wheelchairs, walkers, rubber crutch tips, plastic bedpans, mother and infant identification bracelets, oxygen humidifier bottles, orthopaedic canes, ice packs, ultrasonic periodontal treatment devices, electric autoclaves, dental treatment units, light-curing lamps, dental handpieces, X-ray film, amalgamators, dental X-ray machines, monitors, medical examination tables, hospital bed sheets, oxygen masks and nebulizers, and it closes with an Otros catch-all entry. Knowing this list is valuable because it removes whole equipment families from the registration workload, but the exemption is narrowly drawn, and the sections below show where its edges lie. Reading the list carefully also pays off at customs: an item genuinely on the list can be cleared without a sanitary registration number, which changes the documentation pack that accompanies the shipment, whereas an item wrongly assumed to be on the list creates a discrepancy that surfaces at the border or during later market surveillance.

2. Legal basis

The exclusion route, the list itself, the note attached to it and the refusal provision are set out below. Although the note on withdrawal primarily concerns registered products that fail testing, it is reproduced alongside the exemption list because it shapes how the exemption is read: the regime still anticipates laboratory control for products that require testing, so the exemption and the testing regime operate on different populations of products.

3. Expert insights

Insight one: what is exempt is the sanitary registration, not the oversight. Annex 2 waives only the registration obligation; it does not waive quality, labelling or import-stage requirements. The equipment still clears customs under the general trade rules, and if its actual use changes so that it falls within the device definition, it returns to the registration channel. The exemption is therefore a filing relief tied to a specific product as listed, not a general licence for anything that resembles the listed equipment, and teams should keep the certificate-free status documented rather than assumed.

Insight two: the list is dominated by equipment; consumables are not on it. Annex 2 enumerates durable equipment such as wheelchairs, walkers, hospital beds, monitors and dental chairs, while dressings and surgical materials are expressly devices under Article 4, so the two do not overlap. Applying Annex 2 to consumables is a common misjudgement. A quick test before any claim of exemption is to ask whether the item would appear in a catalogue of durable medical equipment or in a consumables order form; the list entries, read as a whole, belong to the first group.

Insight three: the Otros catch-all is not a discretionary power. The Other entry at the end of the list must be determined by DRCPFA using the decision axis of Article 12 and Annex 1; companies cannot assign their own products to it. Self-assessing an item as exempt and importing it unregistered triggers problems on both the import side and the sales side once the item is found to require registration, and the resulting gap between the declared status and the actual classification is difficult to close retroactively.

Insight four: the list works together with Article 2. Article 2 places products for the disinfection and sterilization of devices and the Annex 2 list side by side as exclusions, which shows the exclusion logic has two lines: one by purpose (disinfection and sterilization products do not follow the device route) and one by list (the equipment exemption). Keeping the two lines separate matters when a product combines both traits, because the applicable reasoning and the resulting obligations differ.

4. Practical recommendations

• Compare item by item against the Annex 2 list; mark hits as registration-exempt in the internal ledger and keep the comparison records, including the exact list wording relied on.
• Route every non-hit item through device registration and never apply the Otros entry on your own initiative, however similar the product looks to listed equipment.
• For registration-exempt equipment, still confirm the other import-stage requirements, and never treat the exemption as covering all compliance, since customs formalities, taxes and trade documentation remain in force.
• Where the use or configuration of a product changes, compare it again against Annex 2 and the device definition, and document the second comparison in the same ledger entry as the first.
• Write the Annex 2 comparison conclusion into the product market-access report, as the supporting basis at the import stage and as evidence of a deliberate determination if the entry is later questioned.

5. Verification checklist

• □ The NT-37 Annex 2 list has been compared item by item
• □ Hit items are marked registration-exempt with records retained
• □ Non-hit items are planned for device registration
• □ The Otros catch-all has not been applied on the company side
• □ Other import-stage requirements have been confirmed for exempt equipment
• □ The Annex 2 comparison conclusion is written into the market-access report

Regulatory information verified as of 29 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Guatemalan market. Our team manages Ministry of Public Health and Social Assistance (MSPAS) registrations, coordinates import and distributor requirements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com