Family applications and the three situations where the family concept does not apply

Updated: 2026-11-11 · GRZAN Regulatory Team · Verification date 2026-10-20

1. Key takeaways

Panama allows a CCT to be applied for by family (familia de dispositivos médicos), but three situations do not use the family concept. First, biomedical equipment, expressly excluded by the last sentence of Article 27 of DE 490. Second, trays, sets, combinations, kits, systems or product assemblies, under Article 28. Third, categories excluded by a dedicated resolution: Article Noveno of Resolución N° 003 de 2024 states expressly that condom registration does not apply the device family concept. A family is defined as a group of devices from the same manufacturer that differ only in colour, shape, size or flavour, share the same design, intended use and manufacturing process, and are intended for a similar purpose.

The family test is a test of the dimension of difference, not of the number of models.
Differences in material, sterilisation method, performance parameters or software version fall outside the family and create separate products.
A family application does not reduce the documentation: every model in the group must satisfy the full requirements.
Biomedical equipment is excluded because it is individualised by model, serial number and technical service requirements.
Trays and kits run on a different mechanism, where the submitted material covers the group with additions only where justified.
Condon registration is the working precedent for a category-specific exclusion of the family concept.

2. Legal basis

The definitions establish what a family is; Articles 27 and 28 establish how it is applied and where it stops. The resolution of 2024 shows the mechanism being switched off for one category by an instrument of lower rank.

Instrument	Provision	Key point
Decreto Ejecutivo N° 490 (4 October 2019)	Article 2, definition 59	Device family: a group of devices from the same manufacturer, differing only in colour, shape or size, sharing the same design, intended use and manufacturing process and intended for the same purpose
Decreto Ejecutivo N° 490	Article 2, definition 32	Devices by family (the DE 490 version of the definition, which adds “or flavour”)
Decreto Ejecutivo N° 490	Article 27	A family application must use the established form and list every product in the family; the same requirements apply to the whole group as to an individual device; biomedical equipment is excluded from the family concept; the certificate must describe every device in the family
Decreto Ejecutivo N° 490	Article 28	Trays, sets, combinations, kits, systems or product assemblies are not defined as a family; DNDM sets a separate procedure and requirements; the material covers all products in the group; additional requirements apply only where there are justified differences and according to risk class
Decreto Ejecutivo N° 490	Article 2, definition 67	Kit: a set of health products (which may be devices, medicines and consumables) packed in a secondary container for a specific purpose defined by the manufacturer
Decreto Ejecutivo N° 490	Article 2, definition 9	Definition of a surgical tray
Resolución N° 003 (15 February 2024)	Article Noveno	Condom registration does not apply the device family concept
Ley N° 90 (26 December 2017)	Article 17	DNDM may register devices that comply with the law by family; devices grouped by family are covered by a single application

3. Expert insights

Insight 1. The family test asks which dimensions differ, not how many models there are. Definition 59 limits acceptable variation to colour, shape and size, with the DE 490 version of definition 32 adding flavour. Any difference outside those dimensions — material, sterilisation method, performance parameters, software version — does not constitute a difference within a family and makes the item a different product. The most common planning error is to place models with different performance but identical appearance into one family, usually because the marketing names group them together. The grouping that matters here is the technical grouping, and the marketing grouping is not evidence for it.

Insight 2. A family is not a cost-saving device; it is an instruction to submit everything for the whole group. Article 27 provides that the same requirements established for devices applied for individually will be requested for the whole group (se solicitarán los mismos requisitos establecidos para los dispositivos de manera individual para todo el grupo). Every model in the family must therefore satisfy the full set of requirements; there is no representative model whose file stands in for the others. A company that treats the family route as a way to reduce documentation volume will be asked to complete the file model by model during review, which costs more time than preparing it correctly at the outset.

Insight 3. Biomedical equipment is excluded from the family because equipment is individualised. The last sentence of Article 27 reads “Se exceptúa del concepto de familia los equipos biomédicos”. Equipment carries model and serial numbers and technical service requirements under Article 41, and those individual differences cannot be absorbed by variations in colour, shape and size. The consequence for an equipment portfolio is direct: several units must be applied for unit by unit, and certificates are issued unit by unit. Plans built on a family assumption for equipment tend to understate both the number of applications and the number of certificates to be maintained over the five-year cycle.

Insight 4. Kits and trays follow a different procedure whose coverage mechanism runs the opposite way. Article 28 provides that for trays, sets, kits, systems or assemblies the required material covers all products within the group, and that additional requirements apply only where there are justified differences and according to risk class. That is not the family rule of full submission for every member; it is one set of material covering the group, with additions for exceptions. The two mechanisms are structurally different and the documentation cannot simply be moved from one to the other, because what is a required item under Article 27 may be an exception item under Article 28.

4. Practical recommendations

Run a difference-dimension review before planning a family: accept only differences in colour, shape and size (or flavour) and split everything else into separate products.
Prepare the documentation on the basis of full submission for the whole group, and set no expectation of a documentation reduction.
Schedule and budget equipment lines unit by unit, without applying the family model.
Build a separate documentation structure for kits and trays under Article 28, following the logic of one covering set plus additions for exceptions.
Check first whether a dedicated resolution excludes the family concept for the specific category, with condoms as the precedent.

5. Verification checklist

□ Confirm that variation within the family is limited to colour, shape and size (or flavour)
□ Confirm whether biomedical equipment is involved (excluded by Article 27)
□ Confirm whether the product is a tray, set, kit, system or assembly (excluded by Article 28)
□ Check whether a dedicated resolution excludes the family for the category (Article Noveno of Resolución 003)
□ Verify the completeness of each model’s documentation on the full-submission basis
□ Check that the certificate describes every device in the family (last sentence of Article 27)

Related reading: [The CCT numbering rule: reading the six groups MQ, EB, IMA, LAB, ODO and OT](/panama-medical-device-registration/cct-numbering-system-panama/) | [Reliance pathway: expedited validation and acceptance of reference authority certificates under Article 18 of Ley 90](/panama-medical-device-registration/reliance-pathway-reference-authorities-panama/) | [Apostille and consular legalisation: Article 35 of DE 490 and Ley 6 de 1990](/panama-medical-device-registration/apostille-and-consular-legalisation-panama/)

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 Panamanian 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

Disclaimer

Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.

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