Guatemala Medical Device Registration: NT 37 Article 5 Document Checklist

1. Key takeaways

The document checklist for the sanitary registration of medical devices in Guatemala is set out in Article 5.1 of NT 37 Versión 5-2016 and comprises thirteen items: proof of payment of the registration fee, application form F-AS-f-08, finished product specifications, product description, certificate of free sale, good manufacturing practices certificate, authenticated photocopy of the manufacturer’s letter of authorisation, analytical methods, quality control certificate, original packaging or readable mock-up, sealed samples, technical literature or package insert, and a photocopy of the sanitary licence of the registration holder. The dossier must be submitted in a natural-colour ring binder folder, and three of the thirteen items are marked as submitted only when applicable. Understanding the full list, its internal order and its conditional entries is the foundation of every well-built Guatemalan dossier, because a formal review at the window will check the dossier against this list item by item before any technical assessment begins.

• Thirteen items are listed under Article 5.1, and each carries its own sub-clause number.
• The payment voucher is the first item, and the fee expressly includes sanitary surveillance.
• The finished product specifications and the product description must both be in Spanish.
• The letter of authorisation requires an authenticated photocopy; the sanitary licence requires only a simple photocopy.
• Packaging must be the original or a readable mock-up — photocopies and overlaid labels are not accepted.
• Analytical methods, sealed samples and technical literature are the three items qualified by “cuando aplique”, meaning when applicable.

2. Legal basis

The table below reproduces the thirteen-item checklist of Article 5.1 in the order fixed by the technical standard, together with the clause that governs each item. Keeping this table as the master index of the dossier is the most reliable way to make sure that nothing is missing when the file reaches the submission window.

3. Expert insights

Insight one: the payment voucher is listed first, and the fee includes sanitary surveillance. Article 5.1.1 states that the fee “contempla también la vigilancia sanitaria” — it already covers sanitary surveillance. This means the official fee is not merely the consideration for processing the application; the cost of post-market oversight is built into it from the start. A budgeting model should therefore not treat this payment as a one-off administrative charge that ends once the certificate is issued, but as a contribution that continues to fund the surveillance system throughout the life of the registration. Planning teams that internalise this reading avoid underestimating what the Guatemalan fee actually represents.

Insight two: Article 5.1.10 imposes the strictest formal requirements on packaging. The clause states plainly “No se aceptan fotocopias ni etiquetas sobrepuestas” — photocopies are not accepted, and neither are overlaid labels. This elevates the packaging mock-up from a supporting reference to a formal requisite of the dossier. A submission built on photocopied artwork or on labels stuck onto an existing pack will be rejected at the threshold, before the merits of the product are ever discussed. Preparing genuine originals or properly produced readable mock-ups is therefore not cosmetic diligence; it is a pass-or-fail condition for the entire file.

Insight three: Articles 5.1.7 and 5.1.13 treat photocopies differently. The letter of authorisation requires a “fotocopia autenticada” — an authenticated photocopy — while the sanitary licence of the registration holder needs only a “fotocopia simple”, a simple photocopy. The coexistence of two different photocopy standards within one dossier shows that the authority distinguishes the source of validity of each document. The authorisation comes from a foreign manufacturer abroad, so an authentication step is needed to give it probative force locally; the sanitary licence is issued by a domestic authority and can be verified against official records. Mixing the two standards, either by over-authenticating the licence or by submitting a plain copy of the authorisation, signals unfamiliarity with the checklist.

Insight four: the three “when applicable” clauses are the source of review flexibility. Analytical methods (5.1.8), sealed samples (5.1.11) and technical literature (5.1.12) all carry “cuando aplique”. Whether they apply is strongly linked to the risk class. Annex 1 makes clear that Class I products are exempt from laboratory testing, so sealed samples will typically not apply for Class I; Classes II to IV must be tested, so samples and analytical methods will most likely be required for them. Making an explicit, documented applicability determination for these three items turns a potential source of window queries into a controlled, predictable element of the dossier.

4. Practical recommendations

• Build a thirteen-item documentation tracker from Article 5.1, recording for each item its status, issuing party, validity period and translation state.
• Handle the three “when applicable” clauses as separate applicability determinations, and record the reasoning in the dossier file.
• Prepare packaging exclusively as originals or readable mock-ups, and never submit photocopies or samples carrying overlaid labels.
• Obtain an authenticated photocopy of the letter of authorisation and a simple photocopy of the sanitary licence, and keep the two standards apart.
• Assemble the complete dossier in a natural-colour ring binder folder as required by Article 5.1.

5. Verification checklist

• □ All thirteen items are complete and each is annotated with its current status
• □ The payment voucher is placed as the first item of the dossier
• □ The application form carries the signature, stamp and emboss seal in full
• □ Applicability has been determined for the three “when applicable” items
• □ Packaging is original or a readable mock-up, with no photocopies or overlaid labels
• □ The letter of authorisation is an authenticated photocopy and the sanitary licence a simple photocopy
• □ The dossier is assembled in a natural-colour ring binder folder

Regulatory information verified as of October 29, 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