Import Permits Under NT 26 Versus Sanitary Registration: Two Parallel Tracks

1. Key takeaways

Obtaining the sanitary registration does not by itself allow importation. Guatemala manages the import permit as a separate procedure under NT 26-2016 Versión 3-2017, Procedimientos para la emisión de permisos de importación (procedures for issuing import permits, updated 2018-06-08). The sanitary registration proves that the product may be marketed in the country; the import permit decides whether the goods may enter it. The two tracks run in parallel and neither can be skipped. Customs clearance adds a third layer, handled by the Superintendencia de Administración Tributaria (SAT), the tax administration authority. A company that plans only for the registration and assumes goods will flow afterwards will discover at the border that a second authorisation was always required, and that the clearance layer has its own data expectations. Sequencing all three tracks from the start is the only way to keep the supply chain uninterrupted, because each track has its own processing rhythm and none of them can be compressed at the border by goodwill or urgency.

2. Legal basis

Basis: NT 26-2016 Versión 3-2017 as updated on 2018-06-08, read together with NT 37, Versión 5-2016 (2016-02-22) and the Health Code, Decreto 90-97. Together these instruments separate the market-access question from the border question while tying them together through the registration number printed on the packaging.

3. Expert insights

Insight 1: The three tracks answer to different authorities and logics. The sanitary registration is reviewed by DRCPFA under NT-37 or NT-40 and looks at the product; the import permit follows the procedure of NT-26 and looks at the shipment; customs clearance is managed by SAT, which looks at taxes and the movement of goods. A company therefore faces three interlocutors with three different sets of expectations, and any inconsistency in numbers, batch information or names between the three files will hold up the flow. The operational answer is not to merge the tracks, which cannot be done, but to manage them as three scheduled milestones with a common data set, so that the registration number, the product name and the manufacturer details are identical everywhere they appear.

Insight 2: The sanitary registration number is the connector between the tracks. Articles 7.1.5 and 7.2.4 of NT-37 require the registration number to be printed on both packaging levels precisely so that the import and circulation stages can verify it directly. A registration number that is misprinted, omitted or inconsistent with the certificate affects both customs clearance and market surveillance at the same time, because the same printed element is what both functions check against. Verification of the artwork against the registration certificate before printing, and of the printed packaging against the certificate before shipping, closes this risk cheaply; discovering it at the port closes it expensively. The check should be part of a standing procedure rather than an ad hoc effort, because packaging is reprinted over the life of a registration and every reprint re-creates the opportunity for the number to drift from the certificate.

Insight 3: Exemption from registration is not exemption from import procedure. Annex 2 of NT-37 removes the obligation to hold a sanitary registration for the equipment it lists, but the import stage still runs under the general trade rules. Reading the exemption as a removal of all formalities will get goods stopped at the border. The correct reading is narrower: the product does not need a registration, yet the shipment still needs whatever the import and customs layers require, and the goods will be compared against the Annex 2 list during import handling. Companies importing exempt equipment should document the classification clearly so that the exemption is visible to every officer who handles the file.

Insight 4: NT-26’s version and update date must be recorded separately. The document is cited as 26-2016 Versión 3-2017, updated 2018-06-08: a standard year, a version number and an update date that are three different values. This layering is common in Guatemalan NT numbering, and a registry that collapses it into a single date loses the ability to cite the instrument precisely. Keeping the three fields distinct in the regulatory database, and training staff to quote all three, avoids the small but real frictions that arise when correspondence cites a version the authority indexes differently. It also makes internal audits cleaner, because an auditor reading the registry can tell immediately which revision of the standard the company’s procedures were written against.

4. Practical recommendations

• Schedule the sanitary registration, the import permit and customs clearance as three independent milestones, each with its own lead time.
• Cross-check the sanitary registration number on the packaging against the registration certificate and the import documents, in all three places.
• For equipment exempt under Annex 2, document the exemption clearly and still confirm the other import requirements.
• Record NT-26 in the registry under three fields: standard year, version number and update date.
• Align the filling rules for batch numbers, model designations and manufacturer names with SAT’s expectations in advance.

5. Verification checklist

• □ Registration, import permit and clearance are scheduled as three separate milestones
• □ The packaging registration number matches the certificate and the documents in all three places
• □ Exempt equipment is documented and its import requirements confirmed
• □ NT-26 is recorded under year, version and update date
• □ SAT filling rules have been aligned in advance

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