NT-37 or NT-40: Choosing the Right Registration Channel in Guatemala

1. Key takeaways

Guatemala operates two sanitary registration channels distinguished by the nature of the product: medical devices follow NT-37 v5-2016, which applies a four-class scheme determined by the external or internal use axis crossed with the sterile or non-sterile axis, while in vitro diagnostic reagents follow NT-40 v3-2015, which applies three sanitary risk tiers determined by the intended use and the analyte or specimen tested. The decisive criterion for telling the two apart is the definition of reagents in Article 2.6 of NT-40: a product used to examine specimens taken from the human body, including blood, organ and tissue donations, belongs to the reagent channel; everything else belongs to the device channel. Choosing the wrong channel means reworking the submission from the very first item of the document checklist onward, because the dossier structures, the signature requirements and the supporting evidence of the two standards do not overlap. The channel decision is therefore the first and most consequential planning step, and it should be documented against the literal text of the definitions before any dossier work begins. Teams that record this determination in writing also find it easier to defend the channel choice if the reviewer raises questions later in the review cycle.

2. Legal basis

The two standards can be compared dimension by dimension. The table below summarises the clauses that govern the scope, classification, dossier, signature, validity and renewal of each channel.

3. Expert insights

Insight one: the documentary burden differs markedly, and the heavier side is the device channel. NT-37 requires the free sale certificate and the manufacturer’s power of attorney, while the checklist of NT-40 contains neither of these two items. This is not an omission; it reflects the different degree to which the two channels depend on foreign evidence. The classification axes for devices involve the site of use and the sterility status, which makes market and manufacturing evidence from the country of origin relevant to the assessment. Reagents are tiered by intended use, so the evidentiary weight falls on the quality control certificate and the certificate of manufacturing guarantee (Articles 4.1.4 and 4.1.5). Understanding which axis drives the assessment explains why each standard asks for the documents it asks for, and prevents the pointless exercise of filing device-style evidence in a reagent dossier.

Insight two: the signatory requirement is relaxed in the reagent channel. Article 4.1.2 of NT-40 allows the application to be signed by a Químico Farmacéutico or a Químico Biólogo, whereas Article 5.1.2 of NT-37 names only the Químico Farmacéutico. A reagent company whose responsible professional is qualified in the biological chemistry direction can still satisfy the signature requirement, and this is a workable route that is often overlooked when companies staff their regulatory affairs function around a single professional profile. Checking the signatory qualification early avoids a late-stage scramble to find an eligible professional.

Insight three: combination products of an instrument plus reagents must be assessed by separation. For a product consisting of an instrument with its associated reagents, the instrument part is assessed under Article 3.1 of NT-37 and the reagent part under Article 2.6 of NT-40. Article 2.3 of NT-40 specifically defines diagnostic equipment, including hardware and software, which shows that the reagent standard itself covers instruments; even so, the two channels still need to be planned separately, each with its own dossier, its own timeline and its own certificate.

Insight four: whether one registration number can cover a combination depends on the grouping rules. Article 1 of NT-40 allows reagents, calibrators, controls, buffers and solutions belonging to the same reagent family to be included in a single registration. NT-37 has no corresponding family grouping provision; its only consolidation mechanism is the additional manufacturing site under Article 6.12. The grouping logic of the two channels is different and cannot be applied to each other by analogy, so groupings must be designed strictly within the rules of the channel that the product actually follows.

4. Practical recommendations

• At project initiation, compare the product’s intended use word by word against Article 2.6 of NT-40: whether it is used to examine specimens taken from the human body.
• Split instrument-plus-reagent combination products into two separate workstreams and do not merge them into one application.
• Prepare 13 items for device projects under Article 5.1 of NT-37 and 6 items for reagent projects under Article 4.1 of NT-40.
• For reagent projects, verify the signatory qualification against either Químico Farmacéutico or Químico Biólogo.
• Design reagent family groupings under Article 1 of NT-40, and do not plan family groupings for devices.

5. Verification checklist

• □ It has been assessed under Article 2.6 of NT-40 whether the product is a reagent
• □ Combination products have been split into two separately planned workstreams
• □ The number of dossier items has been checked against the corresponding channel (13 items or 6 items)
• □ The signatory qualification has been verified
• □ Reagent family groupings have been designed under Article 1 of NT-40
• □ It has been confirmed that the validity period is 5 years in both channels

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