Who Regulates Medical Devices in El Salvador: SRS and DNM

1. Key takeaways

The authority that currently regulates medical devices in El Salvador is the Superintendencia de Regulación Sanitaria (SRS), created by Decreto Legislativo No. 891 on 4 December 2023. The SRS took over the functions, resources, databases and staff of the former Dirección Nacional de Medicamentos (DNM) as a whole. One detail is easy to miss: the technical regulation in force, RTS 11.03.02:21, still names the DNM as the authorising body in its operative text. This is the most consequential text-versus-institution mismatch in the market, because it decides whose name appears on the power of attorney, who receives the fee payment and who is addressed in official correspondence.

The consequence for a filing is narrow but decisive. Documents drafted from the operative text point at an institution that no longer carries the function, which at best produces a request for correction and at worst a finding that the applicant is not properly represented. The defect is documentary rather than technical, which is why it survives when a dossier is built from inherited templates.

• The SRS succeeds the DNM under Decreto Legislativo No. 891 and holds the functions, resources, databases and staff.
• RTS 11.03.02:21 still names the DNM in Article 3.5 on the competent authority and in Article 9.1 on inspection and control.
• Sanitary registrations, establishment authorisations and registration records issued under the DNM were not annulled; they migrated with the database.
• Five parties owe cooperation duties under Article 5.4.1: Titular del registro sanitario, Apoderado responsable, Profesional Responsable, Director Técnico and Referente de Tecnovigilancia.
• The RTS has applied since 23 February 2023, six months after its publication on 23 August 2022.

2. Legal basis

The institutional mandate and the technical rule come from different instruments, and the published texts have not been reconciled. Decreto Legislativo No. 891 creates the SRS, while RTS 11.03.02:21, issued as Acuerdo No. 14-2022, remains the technical regulation governing device registration, with Chapter 10 fixing its entry into force. The table sets out the provisions a filing team has to reconcile.

3. Expert insights

Insight one: the text and the executing body have separated, and this is the first filing risk. Article 3.5 states in so many words that “in El Salvador this function in the device field is exercised by the Dirección Nacional de Medicamentos”, and Article 9.1 likewise hands inspection and control to the DNM. Decreto Legislativo No. 891 has moved the DNM mandate in full to the SRS. For an applicant the effect is direct: a poder drafted from the operative text, the payment instruction and the addressee of a correction letter will all point at an agency that no longer performs the function. The failure is rarely isolated, because the template, the certificate and the invoice usually inherit the same outdated reference, so a dossier can look internally consistent and still be addressed to the wrong body.

Insight two: what changed hands is the database and the staff, not merely the name. Decreto Legislativo No. 891 transfers the resources, databases and staff of the DNM together, which means that sanitary registrations, establishment authorisations and registration records obtained under the DNM were not voided but travelled with the database. The first task with an existing client is therefore a comparison: the DNM registration number on the old certificate against the current SRS database, confirming the registration number, the establishment number and whether the three appointed parties, namely the Director Técnico, the Profesional responsable and the Apoderado responsable, are still recorded as active.

Insight three: the cooperation duties of five parties moved with the agency. Article 5.4.1 lists the five parties that must cooperate with the competent authority: the Titular del registro sanitario, the Apoderado responsable, the Profesional Responsable, the Director Técnico and the Referente de Tecnovigilancia. Because the authority changed, the counterparty of those duties changed as well. If any link is still recorded under the old institution, an SRS correction notice has no responsible party to reach and the file stalls.

Insight four: the claim that the Ministry of Health is in charge is a widely repeated but incorrect practical estimate. The common industry statement that devices in El Salvador fall under the Ministry of Health does not hold. The operative text names the DNM, and the body that now executes the function is the SRS. The Ministerio de Salud appears in RTS 11.03.02:21 in only two places: Article 3.12, on the qualification of independent ethics committees, and Article 6.3.2.4 g), on the registration of alcohol users. Neither is a device registration role, and repeating the claim in a cover letter signals that the dossier was assembled from secondary sources.

Insight five: the effective date must be calculated under Chapter 10, not from the year in the code. The number of RTS 11.03.02:21 carries 21 and the publication date is 2022-08-23, but Chapter 10 provides that it enters into force six months after publication, that is on 2023-02-23. Authorisation chains and document templates prepared in the second half of 2022 under the earlier reading lapsed after that date, and reusing them reintroduces both the wrong authority and a superseded structure.

4. Practical recommendations

• Name the SRS as addressee in every new power of attorney, distribution agreement and manufacturing agreement, and state in the opening paragraph that the former DNM functions are exercised by the SRS under Decreto Legislativo No. 891 of 2023-12-04, so that the receiving desk does not raise a standing question.
• Run a status comparison for existing clients before anything else: registration number, establishment authorisation number, the three appointed parties and the payment status of annual fees, checked item by item against the current SRS database rather than assumed from migration.
• Address outbound letters and correction replies to the SRS and keep a standing note on the succession of functions as an annex to the first submission.
• Write the names and registration numbers of the Director Técnico, the Profesional responsable and the Apoderado responsable into the authorisation chain, so that a correction notice reaches a named person.
• Copy the establishment Referente de Tecnovigilancia on all vigilance correspondence, because Article 6.2.1 b) makes that post mandatory for the establishment.
• Enter 23 February 2023 in the internal compliance calendar and re-review every template finalised before that date, including those held by distributors.

5. Verification checklist

• □ Powers of attorney and contracts are addressed to the SRS and carry the succession note
• □ Legacy registration numbers have been compared with the current SRS database, including active status
• □ The Director Técnico registration number is stated in the file
• □ The Profesional responsable and the Apoderado responsable are registered and not expired
• □ A Referente de Tecnovigilancia has been appointed and contact details recorded
• □ Internal templates have been re-checked against the 2023-02-23 effective date

The instruments cited here are the Ley de la Superintendencia de Regulación Sanitaria (Decreto Legislativo No. 891, Diario Oficial No. 227, Tomo No. 441, 2023-12-04); 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 3.5, 5.4.1 and 9.1 and Chapter 10; and the Ley de Medicamentos (Decreto Legislativo No. 1008, Diario Oficial No. 43, Tomo No. 394, 2012-03-02).

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