Regulatory Timeline 2022-2026: Three Technical Regulations and an Agency Handover

1. Key takeaways

The current Salvadoran framework for device regulation took shape between 2012 and 2025, and seven dates carry the structure. The Ley de Medicamentos was issued on 2 March 2012 as Decreto Legislativo No. 1008, followed by its general regulation on 20 December 2012 as Decreto Ejecutivo No. 245. On 23 August 2022, RTS 11.03.02:21 and RTS 11.03.03:22 were published in the same issue of the gazette. RTS 11.03.02:21 entered into force on 23 February 2023 under Chapter 10, which provides for application six months after publication. Decreto Legislativo No. 891, creating the SRS, was published on 4 December 2023. RTS 11.03.04:23 on technical vigilance followed on 12 April 2024, and the Política de Reliance of 8 May 2025 was joined by the 2025 edition of the Tarifario in October 2025.

• Two technical regulations were published on the same day, which is why the device regulation can simply refer to the current GMP RTS rather than restating it.
• The numbering year, publication year and effective date of RTS 11.03.02:21 are three different years.
• The agency handover happened after the main regulation was already in force, so the text names the DNM while the SRS executes.
• The 2024 and 2025 measures pull in opposite directions at once, tightening post-market duties and opening routes to reused evidence.
• A quarterly check of the SRS website and the Diario Oficial is the minimum maintenance routine for a regulatory timeline.

2. Legal basis

The table below sets out the seven instruments in sequence, with the identifying reference and gazette citation for each. Read as a series rather than as isolated entries, they show a framework assembled over more than a decade rather than issued in a single reform.

3. Expert insights

The first point is that two technical regulations were published on 23 August 2022. RTS 11.03.02:21, the main instrument, and RTS 11.03.03:22 on good manufacturing practice both appeared in Diario Oficial No. 156, Tomo No. 436. This explains how Article 5.3.2 can refer directly to the current edition of the device GMP RTS without reproducing it: the two regulations were designed as a pair, so the system requirements and the conduct requirements entered the framework together.

The second point is that the numbering year and the effective year are two years apart, and this is where misreadings most often begin. RTS 11.03.02:21 carries the digits 21 in its designation, was published on 23 August 2022, and took effect on 23 February 2023 under Chapter 10, which allows six months after publication. The number in the designation matches neither the publication year nor the effective year. Reading the 21 as 2021 is a common error across the industry, and it propagates into memos and training material whenever the mistake is copied rather than checked.

The third point is that the agency handover occurred after the main regulation had already taken effect, producing a mismatch between the text and the executing body. The main regulation applied from 23 February 2023, whereas Decreto Legislativo No. 891 creating the SRS was not published until 4 December 2023. The RTS therefore refers to the DNM while the SRS performs the functions. This mismatch is a natural product of institutional evolution rather than a drafting error, but it places an obligation on the applicant to align every outward-facing document to the SRS without rewriting the underlying text.

The fourth point is that the 2024 and 2025 measures concentrate on two ends at once, post-market control and cost. RTS 11.03.04:23 of 12 April 2024 placed technical vigilance in a standalone regulation and tightened post-market obligations, while the reliance policy of 8 May 2025 and the October 2025 fee schedule opened evidence reuse and made prices explicit. Understanding this combination of tightening and loosening is the key to reading the current regulatory direction, because the two movements are deliberate and simultaneous rather than contradictory.

4. Practical recommendations

• Turn the seven dates into a timeline on the first page of the internal manual, so that the designation year is not confused with the effective year.
• Whenever RTS 11.03.02:21 is cited, state both the publication date of 23 August 2022 and the effective date of 23 February 2023.
• Name the SRS as the authorising body in outward documents, noting the DNM succession where the underlying article still uses that name.
• Move the vigilance obligations under RTS 11.03.04:23 out of the transitional category and into current obligations.
• Add the reliance policy and the 2025 fee schedule to routine reviews as the two new variables in filing strategy.
• Review the SRS website and the Diario Oficial each quarter to confirm whether the timeline needs supplementing.

5. Verification checklist

• □ The seven-date timeline is included in the internal manual
• □ RTS 11.03.02:21 is cited with both dates
• □ The authorising body in outward documents is stated as the SRS
• □ Vigilance obligations are treated as current obligations
• □ The reliance policy and 2025 fee schedule are included in reviews
• □ A quarterly review routine is in place

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