Sealed Samples and LNS Laboratory Testing by Risk Class

1. Key takeaways

Testing obligations in Guatemala are determined by risk class: Annex 1 of NT 37 Versión 5-2016 makes clear that Class I (external use, non-sterile) is exempt from testing, while Class II (external use, sterile), Class III (internal use, non-sterile) and Class IV (internal use, sterile) all require physicochemical and microbiological testing. Sealed samples are submitted under Article 5.1.11 in the quantities set by the LNS list, and the testing itself is performed by the National Health Laboratory (LNS), which operates as a process independent of the document review conducted by DRCPFA. Because the certificate can be granted while testing is still outstanding, project plans that end at the document approval line systematically understate the real timeline, and the two tracks must be scheduled separately with their own owners and milestones.

• Class I — external use, non-sterile — is the only class exempt from laboratory testing.
• Classes II to IV all require physicochemical and microbiological testing.
• Sealed samples follow the LNS quantity list and are submitted when applicable.
• Analytical methods under Article 5.1.8 are likewise submitted when applicable.
• An adverse LNS result leads to automatic revocation of the registration and a market withdrawal within 15 days.
• Document review by DRCPFA and sample testing by LNS are two separate processes with separate timelines.

2. Legal basis

The table below summarises the provisions that allocate testing duties by class and give the laboratory result its legal force. The entries show that classification is the hinge of the whole testing question, and that a failing result carries consequences that reach straight into market withdrawal.

3. Expert insights

Insight one: the testing exemption has a single tier, and it carries two conditions. Class I in Annex 1 corresponds to external use combined with a non-sterile presentation. As soon as the sterile status becomes yes, the product moves to Class II even though it remains an external-use device, and testing is triggered. The sterile configuration is therefore the watershed that decides whether a project must enter the laboratory track. Products offered in both sterile and non-sterile variants effectively split into two classification outcomes, and each variant must be planned on its own footing rather than inherited from the other.

Insight two: the testing annotation for Class III differs from Classes II and IV. Annex 1 writes “control microbiológico” — microbiological control — for Class III, while for Class II and Class IV it writes “producto estéril” — sterile product. Although all three classes share the same headline of physicochemical and microbiological testing, the concrete focus differs by class, and the preparation of samples and analytical methods under Article 5.1.8 should follow that focus. A single undifferentiated testing plan applied to all classes will misalign with what the laboratory actually assesses.

Insight three: the laboratory result carries revocation force. The annotation to Annex 2 provides that where the LNS finds a product “No Cumple” — non-compliant with the specifications — the registration is automatically revoked and the responsible party and the responsible professional must withdraw the product from the market within 15 days. This is not an opportunity to correct the dossier; it is a direct consequence. It follows that the sealed samples must come from a batch consistent with the commercialised product, because submitting a curated or preferable batch for testing creates a lasting exposure that surfaces precisely when the authority compares the tested product with what is on the market.

Insight four: testing and review are two processes, and their timelines must be planned separately. DRCPFA is responsible for document review, while the LNS is responsible for sample testing. Treating the certificate as the finish line ignores the fact that the laboratory result may still be pending behind it. A project plan should therefore give the LNS track its own milestone, its own responsible owner and its own contingency path, so that a laboratory finding never arrives as an unmanaged surprise after the file has already been declared complete.

4. Practical recommendations

• Determine the testing obligation immediately once classification is complete: plan Class I production as test-exempt and route Classes II to IV into the testing process.
• Prepare samples strictly to the LNS list, drawn from a batch consistent with the commercialised product, and keep retention records.
• Prepare analytical methods under Article 5.1.8 with the class-specific focus: microbiological control for Class III, sterile-product items for Classes II and IV.
• Give the LNS testing step its own milestone in the project plan, and never share a single timeline with document review.
• Establish an emergency procedure for adverse testing findings so that the 15-day market withdrawal capability can actually be executed.

5. Verification checklist

• □ The class and the testing obligation have been determined under Annex 1
• □ Class I production has been planned as test-exempt
• □ Samples for Classes II to IV have been prepared to the LNS list
• □ The sample batch matches the commercialised product and retention samples are kept
• □ Analytical methods have been prepared with the class-specific focus
• □ The testing milestone is separately scheduled in the project plan
• □ The 15-day withdrawal emergency procedure is in place

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