Scope of Application: Article 2.1 Activities and Article 2.2 Exclusions

1. Key takeaways

Article 2.1 of RTS 11.03.02:21 anchors the scope on establishments registered with the DNM, now the SRS, and on subjects carrying out ten activities: manufacture, import, export, distribution, storage, clinical research, operation of an establishment, sanitary registration, sanitary inspection and post-market surveillance, with other related activities caught by a closing catch-all. It also covers users who take part in the device regulatory cycle whether or not they pursue commercial ends, including members of the Sistema Nacional Integrado de Salud. Article 2.2 then excludes two categories: products that have their own legislation, and products not intended for human use.

The scope provision is where most borderline products are decided, because it does not depend on a product list. It depends on who is doing what, in which registered establishment, and for what purpose.

• Scope attaches to registered establishments and to ten listed activities, not to a catalogue of products.
• A catch-all for other related activities prevents arguments based on a closed list.
• Non-commercial participants are covered, including donations, samples and research use.
• Members of the Sistema Nacional Integrado de Salud fall within the scope.
• Two exclusions apply, and both are tested by legal status rather than by product description.

2. Legal basis

Article 2.1 must be read with the definition of the national health system in Article 3.35, the requirement in Article 5.3.1 that seven activities be conducted through registered establishments, and the five categories of regulated establishment in Article 6.2.1 f). The table records the provisions that a scope assessment should assemble.

3. Expert insights

Insight one: the anchor is establishment registration, not a product list. Article 2.1 opens by applying to establishments registered with the Dirección Nacional de Medicamentos and to the subjects that carry out the listed activities. The result is that a Chinese manufacturer does not need a plant in El Salvador to fall within the regulation: if it has a registered importer or distributor locally, that establishment and its activities are covered. Conversely, cross-border direct mail without a registered local establishment is neither compliant nor an available import channel, since there is no establishment through which the activity can lawfully run.

Insight two: the words with or without commercial ends bring donations, samples and research devices inside. Article 2.1 expressly covers participants con o sin fines de comercialización. That is the legal basis for the eight special import situations in Article 6.4.2, which include donations, samples and scientific research. A donor or a research sponsor therefore cannot argue that the absence of a sale removes the product from supervision, and the paperwork has to be completed before shipment rather than after arrival.

Insight three: public and private health facilities are expressly named. Article 2.1 brings members of the Sistema Nacional Integrado de Salud into the scope, and Article 3.35 defines that system as all elements directly or indirectly related to health in the public and private sectors. Equipment purchased second-hand by a hospital, or equipment donated to it, therefore requires the use authorisation under Article 6.4.3 and cannot be handled as a mere fixed-asset entry. The same applies to refurbished units offered to public institutions through procurement.

Insight four: the two exclusions turn on whether dedicated legislation exists, not on the product name. Article 2.2 refers to products that may be considered devices but have their own legislation, whatever the international classification. The test is the legislative status of the product, not its physical properties, and it is applied category by category rather than by analogy. Veterinary products fall out twice, since they are also excluded as products not intended for human use, which matters where a manufacturer sells the same platform into animal health.

Insight five: the ten activities in Article 2.1 and the seven in Article 5.3.1 are not the same list. Article 2.1 describes who is in scope, while Article 5.3.1 states which activities must be conducted through an establishment registered under the law. The second list is narrower, and the gap between the two is where operational questions arise, for example when an activity is supervised but not tied to a registered premises. A compliance register built from only one of the two lists will therefore either overstate what needs an establishment authorisation or understate what remains supervised. Reading them together, and recording for each activity both whether it is in scope and whether it requires a registered establishment, is the safer construction.

Insight six: the catch-all for other related activities is a live part of the scope, not drafting filler. Article 2.1 lists ten activities and then adds other related activities as a closing category. Because the list is not declared exhaustive, a business model that is not named in it can still be argued into scope, and the argument will be made by the authority rather than by the operator. The practical defence is a short written assessment for each activity in the supply chain, stating whether it falls within the enumerated list, within the catch-all, or outside Article 2.1 altogether, and keeping that assessment with the establishment file so that it can be produced if the question is raised during an inspection.

4. Practical recommendations

• Confirm first whether a registered local establishment exists; if not, complete the establishment authorisation for the importer or distributor, one of the five categories under Article 6.2, before starting registration.
• Route donated, sample and research devices through the special import procedure in Article 6.4.2 rather than declaring them as ordinary goods.
• For second-hand, remanufactured or refurbished equipment bought by public hospitals, apply in parallel for the use authorisation under Article 6.4.3 and observe the limit of no more than five years from the date of manufacture.
• Before deciding admissibility, check whether dedicated legislation exists for the category, and only then decide whether this regulation applies.
• Remove veterinary devices and in vitro products not intended for human use from this scope and redirect them to the corresponding route.
• Put the point that non-commercial use is also regulated into internal training material, so that donation and research projects do not omit the formalities.

5. Verification checklist

• □ A local registered establishment is confirmed (importer, distributor or storage centre)
• □ Non-commercial projects (donations, samples, research) are entered in the scope register
• □ Public sector projects have been assessed against the age limit in Article 6.4.3
• □ Products proposed for admission have been checked for dedicated legislation
• □ Veterinary and non-human-use products are excluded from this scope
• □ Internal training material states that non-commercial use is also regulated

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 2.1, 2.2, 3.35, 5.3.1, 6.2.1 f), 6.4.2 and 6.4.3.

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