Article 2 Exclusion: Disinfection and Sterilization Products in Guatemala

1. Key takeaways

Article 2 of NT 37 Versión 5-2016 expressly excludes two categories of products: first, products used for the disinfection and sterilization of medical devices, and second, the medical equipment listed in Annex 2. Only products falling outside these exclusions are subject to the registration documentation requirements of Article 5, and the exclusion is written into the standard itself rather than left to practice. The correct way to decide whether a product takes the device route is therefore sequential: pass through the exclusion gate of Article 2 first, and only then enter the classification table of Annex 1. Treating the classification table as the natural starting point is the most frequent sequencing mistake, because the table looks self-contained even though the standard itself begins by carving out what it does not cover. Companies that document the exclusion step explicitly tend to reach the correct route faster, since the same intended-use wording that settles the exclusion question also shapes the label text submitted later.

2. Legal basis

The exclusion clause sits among the foundational provisions of the standard, and the four entries below show how it relates to the object clause, the exemption list and the refusal provision. Read together, they place the exclusion at the very front of the analysis: the object clause states what the standard governs, the exclusion clause immediately withdraws two groups of products from it, Annex 2 holds the withdrawn equipment, and Article 10.4 polices the category boundary at review.

3. Expert insights

Insight one: the exclusion turns on use, not on composition. The wording of Article 2 targets productos destinados para la desinfección y esterilización de dispositivos médicos — products destined for the disinfection and sterilization of devices. The same chemical formulation, if labelled for skin disinfection, does not take the same route in Guatemala as one labelled for device sterilization. The intended-use claim is the first gate of the determination. This is why formulation-only reasoning fails here: two products with identical chemistry and different use statements are regulated differently, and the label text, not the recipe, decides which standard applies.

Insight two: exclusion does not mean an absence of oversight. A product excluded from NT-37 is not unregulated; it simply sits outside the device registration channel and may fall under the sanitary regulation of another product category. In market-access planning, companies must confirm the product’s actual governing category at the same time, rather than importing directly once the device route is closed. The exclusion question and the category question are answered in different provisions, so both answers belong in the written record.

Insight three: Article 2 and Article 10.4 form two gates. Article 2 is the exclusion gate built into the standard itself, while Article 10.4 is the backstop at the review stage — if DRCPFA considers that the product does not belong to the device category at all, it may simply refuse registration. The existence of both gates shows the classification determination must be solid before submission; otherwise even a complete dossier may be returned. The two gates also bite at different moments: the first is applied when the scope of the standard is read, the second when the reviewer forms a view on the file, so a weak determination is exposed twice rather than once.

Insight four: the order of the exclusion clause and Annex 1 cannot be reversed. The correct sequence is: first determine under Article 3.1 whether the product is a device, then determine under Article 2 whether it is excluded, and only then determine the class under Annex 1. Skipping the second step and classifying directly will yield wrong conclusions such as external use plus non-sterile equals Class I for disinfection-type products. The three steps form a funnel that narrows in the same order the standard is written, and each step rests on a different article, so the written record should cite the article relied on at each stage.

4. Practical recommendations

• Set the qualification process as three steps: device definition, exclusion gate, classification table, keeping written records of all three steps with the article relied on cited at each stage.
• Have the regulatory team pre-review the intended-use claims and label wording of disinfection and sterilization products, so a device-sterilization claim does not push the product down the wrong route.
• For products excluded under Article 2, separately confirm the regulatory category they actually belong to, and do not assume they are unregulated.
• Before submission, self-check the Article 10.4 risk; if the category of the product is debatable, confirm with DRCPFA first before preparing the dossier, since an early consultation is cheaper than a returned file.
• Write the exclusion determination into the market-access report for citation at the import and sales stages, so downstream teams can reference a settled conclusion instead of re-arguing the route each time.

5. Verification checklist

• □ Confirmed under Article 3.1 whether the product is a device
• □ Confirmed under Article 2 whether the product is excluded
• □ For excluded products, the actual governing regulatory category has been confirmed
• □ Intended-use claims and label wording have been pre-reviewed by the regulatory team
• □ The Article 10.4 category-dispute self-check has been completed

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