The SRS Transition and Its Practical Impact on Device Filings

1. Key takeaways

Decreto Legislativo No. 891, published in Diario Oficial No. 227, Tomo No. 441 on 4 December 2023, created the Superintendencia de Regulación Sanitaria, the SRS, which took over the functions, resources, databases and personnel of the former Dirección Nacional de Medicamentos, the DNM. Three consequences follow directly for applicants. First, the letterhead on powers of attorney, contracts and correspondence changes from the DNM to the SRS. Second, the recipient of payments and the issuer of the mandamiento de pago change to the SRS. Third, the registry for the three named subjects, the Director Técnico, the Profesional responsable and the Apoderado responsable, moves with the institution. The text of RTS 11.03.02:21 still refers to the DNM, which is a matter of textual lag rather than of legal effect.

• The handover changed the institution, not the regulation, so the substantive requirements are unchanged while the counterparty is not.
• Three subject registrations move with the agency and should be confirmed as active in the SRS database rather than assumed.
• Payments now go to the SRS, and the amount is taken from the payment notice issued at the time.
• Citing the DNM in a quotation while filing with the SRS is a durable state, not a temporary inconsistency to be corrected by rewriting the article.
• The SRS holds its own regulatory power, which makes its website a standing monitoring target rather than a one-off reference.

2. Legal basis

The legal basis below combines the creating law, the provisions of the device regulation that still name the DNM, and the fee schedule provisions that govern the transition. The table also records the registration duty for the three professional subjects, since that is where the practical verification work concentrates.

3. Expert insights

The first point is that the rebrand is not a textual revision, so the DNM will remain visible in the body of the regulation for a long time. Articles 3.5, 5.1.1 and 9.1 of RTS 11.03.02:21 all name the DNM, while the executing body is now the SRS. Amending a technical regulation follows its own procedure, the nine-stage OSARTEC process described in the DNM note of 14 March 2024, and that procedure does not run in step with an institutional handover. Applicants should therefore accept the long-term arrangement of quoting the article as written, with the DNM in it, and transacting with the SRS in practice.

The second point is that the transitional provisions of the fee schedule confirm the coexistence of two tracks. Article 5 of the 2025 Tarifario states that matters not provided for in the schedule remain subject to the DNM service price law, and Article 6, a transitional provision, preserves the validity of payments made to the DNM before the SRS organic law took effect, in accordance with that law. The pricing basis may therefore be dual during the transition, and the specific amount should be taken from the SRS payment notice issued for the case at hand rather than inferred from a general schedule.

The third point is that the SRS has acquired the power to issue its own regulations, and that is the variable to watch. The DNM note of 14 March 2024 describes the SRS as an authority empowered to publish its own regulations and looks forward to national technical regulations aligned with IMDRF documents. Beyond the RTS instruments issued through the OSARTEC system, the SRS may therefore publish resolutions, forms and system requirements of its own. That possibility is what makes a quarterly review of its publications a necessary routine rather than a prudent extra.

The fourth point is that the transfer of databases and personnel keeps existing registrations valid while making verification necessary. Decreto Legislativo No. 891 transferred functions, resources, databases and personnel, so earlier registrations do not lapse automatically. Even so, when GRZAN takes over an existing client file, the registration number, the premises number and the registration status of all three professional subjects are checked item by item against the current SRS database, because status synchronisation during a migration is not always complete.

4. Practical recommendations

• Change the letterhead on powers of attorney, contracts and correspondence to the SRS, and attach a short note explaining the succession of functions.
• Direct payments to the SRS, taking the amount from the payment notice issued for the specific case.
• Check the registration status of all three subjects item by item against the current SRS database and confirm that each is active.
• Keep the DNM wording when quoting a provision, and add a note on the succession rather than paraphrasing the text.
• Review the SERVICIOS, NORMATIVAS and LISTADOS sections of the SRS website each quarter to track resolutions and forms issued by the SRS itself.
• Record the arrangement of citing the DNM and filing with the SRS in the internal manual, so that new staff do not read it as an error.

5. Verification checklist

• □ Authorisation documents now carry the SRS letterhead
• □ Payments are directed to the SRS
• □ The status of the three subject registrations has been checked against the SRS database
• □ Quotations retain the DNM wording with a note on the succession
• □ A quarterly SRS website review is scheduled
• □ The internal manual explains the mismatch between text and institution

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