Family Grouping Under Annex C: Criteria and Limits

1. Key takeaways

Nicaragua allows one sanitary registration number to cover a product family, but only where all the criteria of Annex C are met simultaneously (Article 7 of Chapter 7 and Annex C, a normative annex, of NTON 24001:2023). There are 6 general criteria: the same trade name, the same brand, the same device type, the same intended purpose, the same manufacturing plant (with registration per plant), and the same packaging configuration. In vitro diagnostics, self-testing and household devices, and surgical instruments have additional grouping rules of their own (Annex C, C.2 to C.4).

2. Legal basis

Family grouping is governed by Article 7 of Chapter 7 and by Annex C, which sets out the cumulative criteria and the specific rules for particular device categories. The key provisions are set out below.

3. Expert insights

Insight 1: the criteria are cumulative, not alternative. The introduction to C.1 states «dos o más modelos se consideran de la misma familia siempre y cuando cumplan con todos y cada uno de los criterios» — two or more models are considered the same family provided they meet each and every one of the criteria. All must be satisfied. Failure on any single criterion requires a separate registration, and this is the first principle of family grouping.

Insight 2: brand is a hard boundary. C.1 b states «No se podrán tener más de una marca para un producto en un mismo registro» — no more than one brand may be held for a product within a single registration. Two branded products from the same manufacturer, even with identical models, must be split into two registrations. This is the rule most often overlooked in multi-brand acquisitions and in contract manufacturing for third-party brands.

Insight 3: the plant criterion defeats the idea of one registration per brand. C.1 e states «Se deberá efectuar un registro por cada planta de fabricación que elabore el producto» — a registration must be made for each manufacturing plant that produces the product. If the same product is made in two plants, two registrations are required even where brand, model and intended purpose are identical. Changing the manufacturing plant is therefore not a simple post-registration change and may involve a new registration.

Insight 4: the shelf life of an IVD kit is taken from the shortest-lived component. C.2.1 states «el plazo de caducidad asignado en el registro será el del componente que tenga el menor plazo» — the expiry period assigned in the registration is that of the component with the shortest period. The registration validity for a multi-component kit therefore follows its shortest-lived component, which directly affects renewal scheduling and stock rotation planning.

Insight 5: culture media follow two different routes, general and selective. C.2.3 provides that general culture media may be combined into a single registration where the composition or formulation and the physical form are the same and the use is general, whereas selective media «deberán poseer registro independiente por cada tipo» — must hold an independent registration for each type.

Insight 6: for self-testing devices, kit sales and individual sales are two different registration routes. C.3 allows test strips, controls and calibrators to be grouped as a kit where they are used on the same instrument and are the only packaging; but «Las tiras, lancetas, porta lancetas deberán poseer su propio registro sanitario, para su presentación individual» — strips, lancets and lancet holders sold in individual packaging must each hold their own sanitary registration. The sales configuration determines how registrations are split, and this should be settled at the packaging design stage rather than at the registration stage.

4. Practical recommendations

• Before grouping, complete a six-item comparison table covering trade name, brand, device type, intended purpose, plant and packaging configuration; tick each one, and split wherever any single item fails.
• Split registrations by brand for multi-brand product lines, rather than trying to accommodate two brands under one registration number.
• Register separately for each plant where a product is manufactured in several plants, and assess before changing a plant whether the route is a change or a new registration.
• Manage the registration validity of IVD kits by their shortest-lived component, and schedule renewal and inventory planning backwards from that date.
• Register selective culture media separately by type, without combining them with general media.
• Determine the sales configuration at the packaging design stage: components sold as a kit may be grouped, while components sold in individual packaging require their own registrations.

5. Verification checklist

• □ Checked and documented all six criteria: trade name, brand, device type, intended purpose, plant and packaging configuration
• □ Confirmed that no second brand is included within a single registration number (Annex C, C.1 b)
• □ Registered the same product separately for each manufacturing plant (C.1 e)
• □ Confirmed the registration validity of IVD kits by the shortest-lived component and scheduled renewal accordingly (C.2.1)
• □ Registered selective culture media separately by type (C.2.3)
• □ Settled the sales configuration at the packaging design stage, with individually packaged components registered separately (C.3)

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Nicaraguan market. Our team manages Ministry of Health (MINSA) sanitary registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com