Device Classification in Guatemala: Annex 1, Site of Use and Sterility

1. Key takeaways

Medical devices in Guatemala are divided into four classes, and the axis of classification is two dimensions: site of use (external or internal) combined with sterile status (non-sterile or sterile). The official classification table in Annex 1 of NT-37 reads as follows: Class I = external use, non-sterile; Class II = external use, sterile; Class III = internal use, non-sterile; Class IV = internal use, sterile. Classification at the same time determines whether testing is required — Class I is the only class exempt from testing, while Classes II, III and IV all require physicochemical and microbiological testing. This makes the classification exercise the single most consequential step early in a Guatemalan project: the class decides the testing burden, the sample quantities to reserve and, to a large degree, the overall timeline. It also explains why the classification report is the document most worth getting right the first time, since every downstream plan — budget, samples, laboratory scheduling — is built on it.

2. Legal basis

The classification rules, the official table and the consequence of a negative classification are set out in the following provisions.

The four combinations determined by Annex 1 are as follows:

3. Expert insights

Insight one: this is a decision axis, not a scoring table. The Annex 1 table is a two-by-two combination table. There is no column for a risk level, and there are no additional rules covering duration of invasiveness, contact with the circulatory system or drug content. To classify a product, only two questions need answering: does it enter the body, and is it sterile. Reading it as a risk-scoring system will produce wrong conclusions, because the scheme deliberately ignores the graduated factors that other jurisdictions use. The classification of a product in Guatemala is therefore often a different class from what a common global risk classification would suggest, and the Annex 1 result is the only one that governs the local registration route.

Insight two: sterile status on its own can move a product up one class. For the same external use, non-sterile is Class I and sterile is Class II; for the same internal use, non-sterile is Class III and sterile is Class IV. Once the sterile manufacturing process changes — for example, moving from non-sterile to sterile supply — the class jumps accordingly and the testing obligation increases with it, and this is not a simple documentation update. Planning teams should treat any proposed change to the supply status as a potential reclassification event with its own cost and schedule consequences.

Insight three: Class I is the only testing-exempt class, and it marks the watershed of cost and duration. Annex 1 writes Inscripción sin análisis directly beneath Class I, while the other three classes are all marked with physicochemical and microbiological testing. The single question of whether the product is sterile therefore decides whether the project must prepare sealed samples and a testing schedule at all.

Insight four: Annex 1 also carries a product example table arranged by medical specialty. The example table covers latex gloves, tongue depressors, bandages, surgical gowns, tracheal tubes, urinary catheters, nasogastric tubes, oxygen masks, suture materials and more. Its function is to anchor the decision axis on concrete categories: for a borderline product, check the example table first, then fall back on the two-by-two combination to reason out the class. Because the examples are grouped by specialty rather than by technology, the table also gives a quick sense of how familiar product families are locally positioned, which is useful when aligning internal classification memos written under other frameworks.

4. Practical recommendations

• Record the classification judgement in a written report; answer whether the product enters the body first, then whether it is sterile, and map the two answers directly onto the class.
• Manage sterile status as a configuration item: whenever the supply status changes, re-determine the class before discussing the type of change.
• Schedule Class I projects on the testing-exempt basis, and for Class II–IV projects schedule LNS testing as a separate workstream with sealed samples reserved.
• For borderline products, check the Annex 1 example table first; where the table is silent, derive the class from the two-by-two combination and keep a written rationale.
• Keep the classification conclusion consistent across the labelling, the instructions for use and the application form, so the reviewer does not require a fresh determination.

5. Verification checklist

• □ The site of use of the product has been determined (external or internal)
• □ The sterile status of the product has been determined (sterile or non-sterile)
• □ The specific class has been mapped using the Annex 1 two-by-two table
• □ It has been confirmed whether the class requires LNS testing
• □ The Annex 1 example table has been checked for a similar product
• □ The classification conclusion is consistent across labelling, instructions for use and the application form

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