IVD Family Grouping under Article 1 of NT-40

1. Key takeaways

Guatemala permits family grouping for in vitro diagnostic reagents: Article 1 of NT 40 Versión 3-2015 provides that reagents, calibrators, controls, and buffers or solutions, provided they are used for the same purpose, may be included as components of that reagent family in one and the same sanitary registration. The precondition for grouping is «the same use (misma finalidad)», and the components must be described through the annexes designated in application form F-AS-f-08. The device channel has no corresponding family grouping provision: NT-37 contains nothing that would allow several device models or variants to be swept into a single registration on family grounds. For a reagent portfolio with many calibrators, controls and auxiliary solutions, family grouping is therefore the principal lever for reducing the number of certificates and the associated renewal workload, but it is a lever that only works when the same-use condition is genuinely satisfied and documented. Where that condition is stretched, the grouping collapses under review and the portfolio ends up with more work, not less.

2. Legal basis

The grouping rules and their boundaries appear in the following provisions of the two standards.

3. Expert insights

Insight one: the same use is the only threshold for grouping. Article 1 phrases the condition as «utilizados con la misma finalidad», without additional qualifiers such as the same manufacturer or the same production site. But precisely because there is only one condition, the reviewer will treat «whether the use is actually the same» as the primary point of scrutiny. Stuffing reagents with different analytes or different specimen types into one family will draw a request to split the family, and the split then has to be executed under time pressure while the application is already in the review queue.

Insight two: grouping reduces the number of registrations, not the depth of the documentation. Family grouping allows a single registration number to cover multiple components and thereby reduces the number of certificates and the workload of renewals. Each component, however, must still be described in the annexes under Article 2.6. The quality of those annexes directly determines whether the review clears the family as filed, so grouping is not a shortcut that reduces work; it concentrates the work into a set of descriptions that must be complete and accurate for every single component.

Insight three: Kits and families are not the same concept. Article 2.8 defines Kits as a combination of reagents intended to be used together to complete an examination, which is a product concept; family grouping is an arrangement at the registration level. A Kit may be registered as a whole in its own right, or it may be registered within the family framework together with its calibrators and controls. Planning must therefore start by clarifying the product configuration and then select the registration approach, rather than assuming that one label fits both situations.

Insight four: devices cannot borrow this rule. NT-37 has no family grouping provision, so devices of multiple models must be registered separately. Only Article 6.12 offers a consolidation path, and it applies to the scenario of the same manufacturer with different production sites and identical packaging and labelling, allowing an alternative manufacturing site to be added while retaining the same registration number. Transplanting the reagent grouping logic onto devices leads to incomplete model coverage and leaves part of the portfolio without a valid registration.

In practice, the family decision is best made once, early, and in writing. The grouping architecture shapes how every later change is processed, how renewals are phased, and how much of the portfolio is exposed when a single component must be modified. A family that is designed around a coherent clinical use, described exhaustively in its annexes, and mapped against the certificate structure before submission gives the reviewer an easy file to approve and gives the marketing authorisation holder a stable structure to maintain over the five-year life of the registration.

4. Practical recommendations

• Design reagent families on the same-use principle: list the components first, then judge whether they can be brought into a single registration.
• Describe every component item by item in the annexes as required by Article 2.6, leaving no blanks.
• Set up separate registrations for reagents with different analytes or specimen types, and do not force them together.
• Plan device registrations model by model, and handle multi-site situations through the addition of an alternative manufacturing site under Article 6.12.
• Record the grouping conclusions in the registration strategy document for later reference in change management and renewals.

5. Verification checklist

• □ The family component list has been drawn up on the same-use principle
• □ The component annexes have been described item by item under Article 2.6
• □ Reagents with different analytes have been placed in separate registrations
• □ The distinction between Kits and families has been made clear
• □ The reagent grouping rules have not been applied to device projects
• □ The grouping conclusions have been written into the registration strategy document

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