Family Grouping Under a Single Registration

1. Key takeaways

Acuerdo No. 0631-ARSA-2023, the Regulation for the Sanitary Control of Medical Devices and Other Devices of Sanitary Interest, permits in Article 39 the grouping of several devices into one sanitary registration: the applicable conditions are that the devices share the same risk class, the same use and/or the same generic name, and belong to the same product owner and the same manufacturer, and that despite differences in sensory characteristics, dimensions or other features, those differences do not significantly alter their indications; alternatively, the provision covers products designated by the product owner as intended to be used together as a system, equipment, kit or set (sistema, equipo, kit o set). The provision also sets the floor standard for grouping: devices brought into one registration must satisfy the same risk class, the same use, the same indications and the same generic name. The GRZAN regulatory team notes that Article 39 states the four identical attributes as cumulative conditions, not alternatives — any single difference forces a split into separate registrations, which is noticeably stricter than the family-grouping approach of some other markets.

• Devices may share one registration when risk class, use and/or generic name, product owner and manufacturer coincide.
• Permitted in-group differences: sensory characteristics, dimensions or other features that do not significantly alter the indications.
• Products designated by the product owner as a system, equipment, kit or set may also be grouped.
• The floor standard: same risk class, same use, same indications, same generic name.
• Any single divergence among the four attributes forces separate registrations.

2. Legal basis

The provisions below set out the grouping conditions, the permitted differences within a group, and the data fields that support the comparison.

3. Expert insights

Insight one: the four identical attributes are cumulative conditions, not alternatives. The final sentence of Article 39 writes the grouping standard as four parallel requirements — same risk class, same use, same indications, same generic name. The common misjudgement in practice is to compare only risk class and use while overlooking the generic name — devices within one family that carry different generic names (for example two catheter types of different materials) must be split.

Insight two: the permitted in-group differences are limited to those that do not alter the indications. The provision lists sensory characteristics, dimensions and other features, but attaches a single qualifier — that they do not significantly alter the indications. The power to judge this rests with ARSA: when submitting a grouping proposal, the company should explain item by item why each difference leaves the indications unchanged, rather than simply attaching a model table.

Insight three: kits and systems may be grouped on designation by the product owner. The second half of the provision allows products designated by the product owner as a sistema, equipo, kit or set to be used together to enter one registration. This differs from the objective standard of the first half and is a subjective designation pathway — but the precondition is that the designation comes from the product owner itself, and the four identical attributes of the final sentence must still be satisfied.

Insight four: the cost of a failed grouping is higher than filing one more registration. Article 39 provides no remedial procedure after a grouping is rejected; once the reviewer requires a split, a new classification report and a new registration application must be filed, and the classification report has only a 6-month window. The GRZAN regulatory team therefore recommends that for borderline models it is safer to file two registrations than to gamble on one grouping passing.

Insight five: the international codes provide an objective comparison tool for grouping. Item n) of Article 32.1 and item o) of Article 43.1 both require GMDN, UMDNS or EMDN codes to be stated. The hierarchical structure of these codes can be used directly to argue the same generic name — if the models in a group fall under the same code node, the grouping argument becomes considerably more persuasive.

4. Practical recommendations

• Compare the models in a group item by item against the four identical attributes — risk class, use, indications, generic name — and split on any divergence.
• When submitting a grouping proposal, explain in writing why each difference leaves the indications unchanged; do not rely on a model table alone.
• For kits and systems, obtain a written designation document from the product owner as the grouping basis.
• For borderline models, prefer two registrations over gambling on one grouping, avoiding rework inside the 6-month classification window.
• Use the hierarchy of the GMDN / UMDNS / EMDN codes to argue the same generic name.
• Present the grouping proposal for comparison at the classification report stage rather than exposing the divergences at the registration stage.

5. Verification checklist

• □ The models in the group have been compared item by item against the four identical attributes
• □ A written explanation has been prepared for each difference showing it does not alter the indications
• □ A written designation from the product owner is on file for kits and systems
• □ Borderline models have been handled under the principle of splitting rather than gambling
• □ The hierarchy of the international codes has been used to argue the same generic name
• □ The grouping proposal was submitted for comparison at the classification report stage

Further reading: [Article 09 — The four risk classes](/honduras-medical-device-registration/four-risk-classes-i-iia-iib-iii/) | [Article 21 — The Clase I dossier, 16 requirements](/honduras-medical-device-registration/class-i-dossier-sixteen-requirements/) | [Article 18 — Two or more registrations and the two red lines](/honduras-medical-device-registration/multiple-registrants-and-exclusivity/)

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 Honduran market. Our team manages Secretariat of Health (SESAL) registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com