Productos Afines in Panama: Spare Parts, Accessories, Consumables and Health Furniture

1. Key takeaways

Panamanian law treats products related to medical devices (productos afines a dispositivos médicos) as a separate and deliberately broad category. Definition 79 of Article 2 of DE 490 lists the members: spare parts (repuestos), accessories (accesorios), consumables (consumibles), health furniture (mobiliario en salud), materials (materiales), supplies (insumos), personal protective equipment for use in health (equipo de protección personal de uso en salud) and others, closing with a catch-all under which any other product the DNDM considers to belong there also qualifies. The practical consequence of the label is that the product remains governed by Ley 90 but carries a different registration obligation from a complete device (Article 19 of Ley 90).

• Related products are not an exempt category; they are a category with a different obligation.
• Spare parts, accessories and consumables ride on the registration of the equipment they belong to.
• Third-party compatible spare parts need a certificate from the equipment manufacturer before they can be sold.
• The catch-all puts the decision on scope in the hands of the DNDM, which argues for asking before selling.

2. Legal basis

Scope is set by Article 5 of Ley 90 and narrowed for registration purposes by Article 19. The definitions in DE 490 then draw the internal boundaries between a spare part, an accessory and a consumable, and Article 26 opens a route for suppliers who sell only the peripheral items.

3. Expert insights

Insight one: related products are a different-obligation category, not an exemption. The common misreading is that spare parts, accessories and consumables are outside regulation. Article 5 of Ley 90 lists them expressly as health products governed by the law; what Article 19 removes is only the obligation to register separately, because those items are absorbed into the registration of the host equipment. Once the host registration lapses, is cancelled or changes hands, the compliance basis of the accessories and consumables moves with it. This transmission risk is the most frequently overlooked exposure in aftermarket supply, and it surfaces long after the sale, when the equipment registration is amended and nobody re-checks the peripheral items attached to it.

Insight two: the catch-all hands the decision to the DNDM, which in practice means ask before you sell. The final words of definition 79 extend the category to any other product the DNDM considers to belong there. Health furniture and personal protective equipment are the obvious borderline cases, and no fixed list exists to consult. Whether they are in scope depends on the position the DNDM takes at the time. For a company extending its range, obtaining a written position before launch costs far less than correcting the position after the goods have landed.

Insight three: compatible spare parts from another brand are restricted by a clause that is distinctive to Panama. The second paragraph of Article 19 of Ley 90 requires that spare parts of another brand which are compatible with a biomedical device be supported by a certificate from that equipment manufacturer before they may be sold to the health authority’s satisfaction. The effect on third-party parts makers is severe: without an original manufacturer certificate, a compliant product still cannot be sold lawfully. Read together with the marketing certificate in definition 15 of DE 490, the DNDM has in substance built a compatibility attestation mechanism, and the attestation is not something an independent laboratory report can substitute for.

Insight four: Article 26 of DE 490 leaves a door open for the parts-only business model. Under that article, a supplier that does not sell equipment but sells only its accessories and/or consumables may apply for a CCT under a regulation to be issued separately. A pure parts supplier therefore does not have to attach itself to one equipment maker’s registration, provided the DNDM has issued the regulation for that situation. In practice the first step is to confirm whether an applicable procedure exists at the time of filing, which is a practical estimate rather than a settled answer.

4. Practical recommendations

• When building the product master file, tag each item as complete device, accessory, consumable or spare part, citing Article 5 of Ley 90 and definitions 1, 19, 79 and 85 of DE 490 as the basis for the tag.
• Re-check the compliance basis of the accessory line whenever the host device registration is varied, and do not manage aftermarket items on a separate track from the main registration.
• For third-party compatible spare parts, confirm before quoting whether an original manufacturer certificate can be obtained; if it cannot, treat the item as not sellable rather than as a commercial risk.
• For borderline categories such as health furniture and personal protective equipment, obtain a written DNDM position before launch and keep it on file.
• For a parts-only business model, confirm first whether a CCT application procedure for that situation currently exists.

5. Verification checklist

• □ Confirm whether the product falls within the scope list in Article 5 of Ley 90
• □ Confirm whether it is a spare part, accessory or consumable (definitions 1, 19 and 85 of DE 490)
• □ For a spare part or accessory, confirm whether it is absorbed into the host registration (Article 19 of Ley 90)
• □ For a third-party compatible spare part, confirm whether the equipment manufacturer certificate can be obtained
• □ For a borderline category, confirm whether a DNDM position already exists (catch-all in definition 79)
• □ Confirm whether a software update changes device function, since that decides whether a variation is needed

Regulatory information verified to 29 October 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 registrations through the DIGEMID-equivalent medical device directorate, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com