Tecnovigilancia: RTS 11.03.04:23 and the Mandatory Vigilance Liaison

1. Key takeaways

Device vigilance in El Salvador is now governed by a dedicated technical regulation: RTS 11.03.04:23, Vigilancia Postcomercialización de Dispositivos Médicos. Tecnovigilancia, issued by Acuerdo No. DN.05.2024 and published in Diario Oficial No. 68, Tomo No. 443 on 12 April 2024. Article 6.5.3 of RTS 11.03.02:21 channels the vigilance duties of all obligated subjects wholesale to that instrument. Article 3.36 defines tecnovigilancia as the identification, registration, evaluation, management, follow-up and timely disclosure of adverse events and incidents and of safety problems arising from device use. Article 6.2.1 (b) requires every regulated premises to appoint a Referente de Tecnovigilancia, a vigilance liaison. One qualification belongs at the front of this note: the specific reporting timelines and forms in RTS 11.03.04:23 are taken from the gazette original published by the SRS, and this volume makes no clause-level citation of them.

• Vigilance is no longer a soft expectation awaiting implementation; a dedicated regulation has been in force since April 2024.
• Every regulated premises needs a named vigilance liaison, and the appointment should be documented rather than informal.
• The technical director and the professional responsible must coordinate notification and market withdrawal with the liaison, so at least two posts activate together when a vigilance event occurs.
• Where the liaison role is combined with another post, the qualifications must cover both sets of duties.
• Reporting timelines and forms must be read from the gazette original, not from secondary summaries.

2. Legal basis

The framework is layered: the device regulation establishes the duty and the definition, while the vigilance regulation carries the operative obligations. The table below records both, together with the official note that describes how vigilance is executed in practice.

3. Expert insights

The first point is that the vigilance obligation now has an instrument behind it, and the transitional wording has served its purpose. Both Article 6.5.3 and Article 6.2.1 (b) carry the phrase cuando entre en vigencia, meaning when it enters into force, and the instrument they point to is RTS 11.03.04:23. That regulation was published on 12 April 2024, while the DNM note of 14 March 2024 still described it as awaiting gazette publication. Treating vigilance today as a requirement that has not yet landed is no longer defensible.

The second point is that the vigilance liaison is a mandatory post at premises level, standing alongside the professional responsible and the technical director. Article 6.2.1 (b) requires two named persons at the premises, the technical director and the vigilance liaison. Article 3.31 defines the latter as a professional qualified in vigilance and familiar with how the device operates, responsible for leading vigilance activities at an industrial or healthcare provider institution. Articles 6.2.4.1 (m) and 6.2.4.2 (i) permit the role to be held concurrently by the technical director or the professional responsible, but a combined appointment must still satisfy the qualification and function requirements of the RTS.

The third point is that vigilance is not a single-post function, because the text builds in a coordination mechanism across posts. Article 6.2.4.1 (l) requires the technical director to coordinate with the vigilance liaison on notification of and timely response to national or international health alerts, market withdrawals and other safety situations. Article 6.2.4.2 (e) imposes the same requirement on the professional responsible. When an event occurs, at least two posts must therefore activate at once, and the company’s vigilance procedure has to describe the linkage between them rather than assigning the matter to one desk.

The fourth point is a deliberate boundary. The PDF of RTS 11.03.04:23 offered on the SRS website is the gazette original, whose body pages are scanned images without a searchable text layer. GRZAN’s verification rule is to place the verifiable publication details in the body of the note — Acuerdo No. DN.05.2024, Diario Oficial No. 68, Tomo No. 443, 12 April 2024 — and to leave specific reporting timelines and forms to the gazette original, without extrapolating and without citing secondary sources. The content of the DNM note of 14 March 2024 on CNTV execution, FSCA and FSN practice, and the reference authorities is marked in this volume as an official auxiliary source.

4. Practical recommendations

• Appoint the vigilance liaison in writing for each regulated premises, and keep the appointment document and contact details on file.
• Write the linkage between the technical director, the professional responsible and the vigilance liaison into the vigilance procedure.
• Where the liaison role is combined with another post, confirm that the individual’s qualifications cover both sets of duties.
• Align the event response procedure with RTS 11.03.04:23, and stop relying on transitional arrangements.
• Take reporting timelines and forms from the gazette original of RTS 11.03.04:23 published by the SRS, not from secondary summaries.
• Prepare templates for field safety corrective actions and for the field safety notices used to communicate them.

5. Verification checklist

• □ The vigilance liaison is appointed in writing and the record is filed
• □ The linkage between the three posts is written into the vigilance procedure
• □ Qualifications have been confirmed for any combined appointment
• □ The vigilance procedure has been switched to RTS 11.03.04:23
• □ Reporting timelines and forms are taken from the gazette original
• □ FSCA and FSN templates are prepared in advance

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