Holding Structure in Guatemala: Manufacturer, Registration Holder and Importer Responsibilities

1. Key takeaways

The holding structure in Guatemala involves three parties: the foreign manufacturer (issuing the letter of authorisation and the manufacturing evidence), the registration holder (Titular) (which must be a distributor or wholesaler domiciled in the country holding a sanitary licence, NT 37 Article 5.1.13), and the importer (handling the import licence and customs clearance, NT 26 v3-2017). The responsibilities of the three parties are expressly allocated by the documentation items of Article 5 of NT 37, and among them the registration holder and the responsible professional also jointly bear the market withdrawal obligation when a test fails (Annex 2 note, within 15 days). The import stage adds a fourth function, handled under NT 26 v3-2017, which may sit with any of the three parties or with a separate logistics provider, depending on the commercial model. Because the obligations attach to named roles rather than to the product, the choice of who occupies each role is itself a compliance decision. A structure that looks convenient commercially can concentrate obligations on a party that cannot execute them, while a structure built deliberately keeps the regulatory duties and the commercial risks in separable lanes. The table below is the reference point for that design: it shows which role carries which obligation and under which article, so that the division of duties written into contracts matches what the authority will enforce.

2. Legal basis

The table below allocates the obligations across the roles in the holding structure. Each obligation is tied to a specific article of NT 37 or to the import standard, so the table can be used directly as the checklist when contracts and appointment documents are drafted.

3. Expert insights

Insight 1: The registration holder and the importer can be the same entity, or they can be separated. NT 37 only requires the registration holder to hold an establishment sanitary licence (Article 5.1.13), and the import stage runs separately under the NT 26 procedure. Combining the two reduces coordination costs, but it exposes the registration to direct shock whenever the commercial channel changes. Separating them increases the volume of coordination, but it insulates the registration asset from channel risk. Neither choice is free; the decision should be made consciously, with the trade-off documented at the project initiation stage, and revisited whenever the distribution model changes materially.

Insight 2: The withdrawal obligation binds the registration holder and the responsible professional together. The Annex 2 note requires the “propietario y responsable” jointly to withdraw the product within 15 days. This means the registration holder is not a nominal certificate holder but a party bearing substantive legal consequences. When selecting the registration holder, its execution capability and willingness to cooperate should be assessed, precisely because the withdrawal duty cannot be performed by the manufacturer remotely. A holder without warehouse control, distribution visibility or staff to run a recall will convert a 15-day obligation into a failed one.

Insight 3: The manufacturer keeps control through the letter of authorisation. The letter of authorisation under Article 5.1.7 determines who can represent the manufacturer before the DRCPFA. Its scope should cover registration, changes and renewal, and a mechanism for re-issuance should be retained — this is the legal instrument through which the manufacturer preserves its initiative within the holding structure. An authorisation that is narrow or stale transfers practical control to the holder by default. For this reason the authorisation documents should be inventoried at the same cadence as the registrations themselves, with expiry dates tracked alongside the certificate dates.

Insight 4: Article 6.1 provides the exit for adjusting the structure. Change of holder is listed as the first category of change, requiring the legal documents, the original registration certificate, the original packaging and the payment receipt. The structure can be adjusted afterwards, but the cost and the cooperation requirements are not low, so it is best to get the structure right at the project initiation stage rather than relying on a later change. Where an adjustment proves unavoidable, the four documentation items should be collected before the filing is made, because an incomplete holder-change submission restarts the review rather than advancing it.

4. Practical recommendations

• Fix the three-party structure once at project initiation and record the division of duties in a written document.
• Keep the registration holder separate from the commercial channel wherever possible, so that channel changes do not strike the registration asset.
• Cover registration, changes and renewal in the letter of authorisation, and retain a mechanism for re-issuance.
• Assess the execution capability of the registration holder, particularly its ability to perform the market withdrawal obligation.
• Prepare the four documentation items for structural adjustment under Article 6.1, and reserve time for the procedure.

5. Verification checklist

• □ Division of duties among manufacturer, registration holder and importer fixed in writing
• □ Registration holder holds a valid establishment sanitary licence
• □ Scope of the letter of authorisation covers registration, changes and renewal
• □ Execution capability of the registration holder assessed
• □ Contingency plan for structural adjustment prepared under Article 6.1
• □ Import stage scheduled separately under NT 26 v3-2017

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