Medical Device Definition under Article 3.14 of RTS 11.03.02:21

1. Key takeaways

El Salvador defines a medical device in Article 3.14 of RTS 11.03.02:21, in terms consistent with GHTF and IMDRF wording: any instrument, apparatus, device, machine, implant, in vitro diagnostic reagent, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, on the human body, for one of seven purposes (items a to g), and which does not achieve its principal intended action in or on the body by pharmacological, immunological or metabolic means, although it may be assisted in its function by such means. The order of assessment is fixed: first the manufacturer’s intended purpose, then the principal mode of action.

Two consequences follow immediately. The definition is purpose-driven rather than catalogue-driven, so no list of product types decides the question. And because software is named in the article itself, the absence of a physical article does not remove a product from scope.

• The definition sits in Article 3.14 and covers instruments, apparatus, machines, implants, IVD reagents, software and materials.
• Seven purposes are listed, from diagnosis and prevention to disinfection of devices and control of conception.
• A product is excluded where its principal intended action is pharmacological, immunological or metabolic.
• Article 3.17 brings biomedical equipment and the software required for its operation into the same framework.
• Article 2.2 excludes products that have their own legislation and products not intended for human use.

2. Legal basis

The definition does not stand alone. It is read together with the articles that define clinical trials and biomedical equipment, the exclusions in Article 2.2 and the classification rule in Article 6.3.1 a), which uses the same intended-purpose test. The table records the provisions that a scope assessment has to cover.

3. Expert insights

Insight one: software is written into the definition, and stand-alone software is not exempt. Article 3.14 places software on the same footing as instruments and implants, and Article 3.17 goes further by bringing information programs that participate in the normal operation of equipment within the scope of biomedical equipment. Stand-alone medical software and embedded software therefore both fall inside the device definition, and the absence of a physical article is no basis for importing a product as ordinary IT equipment. Article 6.3.2.3 adds a separate set of seven items for medical information systems, which confirms that the regulator expects a software file rather than a hardware file.

Insight two: the axis of assessment is the manufacturer’s intended purpose, not the physical form. Article 3.14 opens with the words intended by the manufacturer, and the classification rule in Article 6.3.1 a) uses the same axis. The same hardware can therefore land in a different risk class and follow a different dossier route depending on the use the manufacturer declares. When a new case is taken on, the first document to be reviewed should be the manufacturer’s statement of intended purpose, including indications, target population and environment of use, because every later decision inherits it.

Insight three: the principal mode of action is the gate that separates drug-device convergence products. The closing exclusion states that the principal intended action is not achieved by pharmacological, immunological or metabolic means, although such means may assist the function. For drug-eluting stents and other combination products the decisive word is principal: where the main effect depends on drug metabolism the product follows the medicines route, while a device whose drug component plays a supporting role remains a device but must provide the BPM certificate of the drug manufacturer under Article 6.3.2.5 g). The assessment has to be argued, not asserted, and the argument belongs in the file.

Insight four: the seven purposes capture disinfectants and contraceptives, which are often misclassified. Within the seven purposes in Article 3.14, item f) covers the disinfection of medical devices and item e) covers the control of conception. Medical disinfectants and contraceptive devices therefore fall clearly within the device definition, even where another market treats them as chemicals or consumer goods. Article 6.3.2.4 sets out nine additional items for medical antimicrobial disinfectants, so the classification is not merely theoretical: it changes the evidence package that has to be assembled.

Insight five: Article 3.17 does not create a second category, it specifies one. The biomedical equipment definition covers electrical, electronic, hydraulic or hybrid systems and the software required for their operation. Read with Article 3.14, it confirms that equipment is assessed as a device and that the software needed to run it is part of the same submission rather than a separate accessory. For an equipment file this affects how the technical description is written: the system, its subsystems and the operating software should be described in one document set, with the software version identified, so that the reviewer is not left to infer where the equipment ends and the software begins.

4. Practical recommendations

• Produce a written statement of intended purpose in Spanish that sets out indications, target population, place of use and contraindications, and use it as the input for classification and dossier route.
• For software products, prepare the seven additional items under Article 6.3.2.3, including the cybersecurity report, version and defect history, and the date on which versions are retired.
• For combination products, decide the principal mode of action first: if the main effect is pharmacological, immunological or metabolic, move to the medicines route; if the drug only assists, file as a device and add the drug manufacturer BPM certificate.
• Do not import medical disinfectants or contraceptive devices as ordinary chemicals or consumer goods; route them through device registration.
• State on the first page of the file that the product meets the Article 3.14 definition and that the principal mode of action is non-pharmacological, non-immunological and non-metabolic, so the conclusion is visible to the receiving desk.
• Run the two exclusions in Article 2.2 first: veterinary products and products with dedicated legislation do not fall under this regulation.

5. Verification checklist

• □ The statement of intended purpose in Spanish is finalised with indications and target population
• □ The principal mode of action has been determined as non-pharmacological, non-immunological and non-metabolic
• □ Software products carry the seven additional items under Article 6.3.2.3
• □ For combination products, the drug manufacturer BPM certificate is obtainable
• □ Both exclusions in Article 2.2 have been ruled out
• □ The Article 3.14 compliance conclusion is stated on the first page of the file

Instruments cited: RTS 11.03.02:21, Dispositivos Médicos. Requisitos para la Regulación Sanitaria de Dispositivos Médicos (Acuerdo No. 14-2022, Diario Oficial No. 156, Tomo No. 436, 2022-08-23), Articles 3.14, 3.16, 3.17, 2.2, 6.3.1 a), 6.3.2.3, 6.3.2.4 and 6.3.2.5 g).

Regulatory information verified as at 29 October 2026.

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