Ley 90 Article 6 Definitions: Devices, IVDs and Biomedical Equipment

1. Key takeaways

Article 6 of Ley N° 90 contains 42 definitions, and together they supply the whole vocabulary on which a Panamanian device classification is built. Three of them decide most cases. The device (definition 14) achieves its principal intended action by means other than pharmacological, immunological or metabolic action, although it may be assisted by such means. The in vitro diagnostic device (definition 16) covers reagents, calibrators, control materials, sample containers, software, instruments and apparatus. The biomedical equipment (definition 21) is operating equipment built from electrical, electronic, mechanical, hydraulic and hybrid systems plus software, and implanted devices and single-use devices that receive no maintenance are expressly excluded from that category. Classification must start from these three definitions, not from what the product looks like.

• The action-mechanism test is the first dividing line between a device and a medicine.
• Software appears in three separate definitions, which produces three possible classification landing points.
• The exclusions in definition 21 decide which documentation items apply and which do not.
• Ley 90 defines 42 terms; DE 490 expands the set to 97, and the additions are the implementation detail.

2. Legal basis

The definitions that carry the most weight in a filing are set out below, with their numbering in each instrument. Citing both the Ley 90 and the DE 490 number is the only way to avoid a version dispute during review, because the same concept sits at a different position in each list.

3. Expert insights

Insight one: the action-mechanism exclusion is the first watershed in Panamanian classification. The exclusion in definition 14 tracks the standard IMDRF and GHTF formulation, but Panama adds a clause that the device may be assisted in its intended function by pharmacological, immunological or metabolic means. That clause creates room for drug-eluting stents, medicated devices and similar products: as long as the principal mechanism is not pharmacological, immunological or metabolic, the product stays inside the device definition. The correct path for a medicated device is therefore to establish the device character of the principal action first, and then to run the combination procedure under Article 20 of Ley 90.

Insight two: software is written into the device definition and separately into the IVD definition. Definition 14 lists software as a device; definition 16 lists it again in the IVD inventory; definition 21 lists computer programs as a component of biomedical equipment. The three provisions are independent, which means software has at least three possible landing points in Panama: as a standalone device, as a component of an IVD, or as a component of biomedical equipment. The landing point changes both the route and the document list. One example is that the instructions for use requirement does not apply to biomedical equipment, as the parenthesis in item 8 of Article 36 of DE 490 makes clear.

Insight three: the exclusions in definition 21 keep three product types out of the equipment route. Definition 21 expressly excludes devices implanted in the human body and single-use devices that receive no preventive or corrective maintenance. This has a direct effect on which documents apply, because items 8, 12 and 13 of Article 36 of DE 490 and Articles 39 and 40 all carry a parenthesis stating that they do not apply to biomedical equipment. Preparing an implant as if it were equipment means submitting a set of items that do not apply. Preparing equipment as if it were a consumable means omitting the evidence of technical support capability required by Article 41.

Insight four: the 42 definitions of Ley 90 become 97 in DE 490, and the increment is implementation detail. Among the definitions added by Article 2 of DE 490 are concepts that decide filing questions: family (item 59), devices by family (item 32), relabelling (item 82), addition of labelling (item 89), expiry date (item 60) and useful life (item 96). A classification exercise that reads only Ley 90 tends to misjudge exactly these questions, for instance whether two products can be merged into one family, or whether an expiry date must appear on the label at all.

4. Practical recommendations

• Run classification in three steps: establish whether the principal action falls within pharmacological, immunological or metabolic means, which decides device against medicine; establish whether the product examines specimens outside the body, which decides IVD; establish whether the product is a system with maintainable parts, which decides biomedical equipment.
• Issue a separate classification note for software products, stating which of the three definitions the product lands in and why the other two were rejected.
• For medicated devices and devices containing biological material, assess in advance whether consultation with the DNFD is required under Article 20 of Ley 90, and search the existing classification resolutions before drafting the argument.
• Cite both numbering systems whenever a definition is quoted, giving the Ley 90 item and the DE 490 item together.
• Put the classification conclusion on the first page of the dossier and update it whenever the product changes, so that later sections of the file do not drift away from it.

5. Verification checklist

• □ Record that Article 6 of Ley 90 contains 42 definitions
• □ Check the exclusion clause and the assisted-by wording in definition 14
• □ Check the inventory scope of definition 16 for IVDs
• □ Check the two exclusions in definition 21 for biomedical equipment
• □ Supplement implementation-level concepts from the 97 definitions in Article 2 of DE 490
• □ Confirm the distinction between product holder and registration holder (definitions 90 and 91 of DE 490)

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