Definitions and Abbreviations: 39 Terms and 8 Abbreviations

1. Key takeaways

Chapter 3 of RTS 11.03.02:21 contains 39 definitions (3.1 to 3.39) and Chapter 4 contains 8 abbreviations: BPC, CRO, DNM, RTS, GMDN, OMS, OPS and IVD. The three concepts an applicant must keep apart are Titular del registro sanitario (3.37, the owner of the product), Profesional responsable (3.29) and Apoderado responsable (3.4). On the establishment side, two posts are mandatory: Director Técnico (3.13) and Referente de Tecnovigilancia (3.31).

These are not interchangeable labels for a local contact. Each carries a different authorising instrument, a different registration entry and a different procedure when the person changes, and the regulation is drafted so that a missing link in the chain is visible on the face of the file.

• Chapter 3 defines 39 terms; Chapter 4 lists 8 abbreviations used throughout the regulation.
• The registration holder is the owner of the product and need not be resident in El Salvador.
• The professional responsible and the responsible agent sit on the product side; the technical director sits on the establishment side.
• Both professional posts require a CSSP practising licence and registration with the authority.
• The vigilance referent is a fourth, separate post, required at establishment level.

2. Legal basis

The relevant provisions are concentrated in Chapter 3, with the operational duties in Article 6.2.1. The table sets out the definitions that a role matrix has to reflect, together with the two provisions that make those roles enforceable.

3. Expert insights

Insight one: the registration holder is the owner of the product and may be a foreign entity. Article 3.37 defines the Titular as the owner of the product and imposes no restriction of nationality or residence. This is what allows a Chinese manufacturer to hold the registration directly instead of transferring it to a local importer, which is a comparatively convenient feature of the Salvadoran system. The price is set by Article 6.2.1 e): every registration must be tied to a Profesional responsable and to an Apoderado responsable, so direct holding does not remove the need for local professional capacity.

Insight two: the professional responsible and the responsible agent are product-side roles, while the technical director is establishment-side. The Profesional responsable under Article 3.29 is authorised by the owner of the device and answers to the authority for product quality and authenticity. The Apoderado under Article 3.4 is designated by a power of attorney. The Director Técnico under Article 3.13 attaches to the establishment and is responsible for its activities. None of the three can stand in for another, and the notification required on a change differs accordingly, since Article 6.2.1 e) requires a variation to be filed for each registration rather than a single global update.

Insight three: both professional posts require a CSSP licence and registration. Articles 3.13 and 3.29 both require a practising licence from the Consejo Superior de Salud Pública (CSSP) and registration with the authority. That is a hard threshold rather than a formality: without a locally licensed professional, neither the registration nor the establishment authorisation can be completed, and a file submitted with an unlicensed nominee will not survive review. Verification of the licence should therefore precede any commitment to a filing timeline.

Insight four: the vigilance referent is a fourth and separate post, and its duty is already live. Article 3.31 defines the Referente de Tecnovigilancia as the professional who leads vigilance activity in industry or in a health service institution. Article 6.2.1 b) makes the post mandatory for an establishment and attaches the duty to the entry into force of the RTS in that field. That condition has been satisfied by RTS 11.03.04:23, published on 2024-04-12, so the requirement is no longer pending and a nomination should be documented rather than planned.

Insight five: because appointments attach to each registration, a broad portfolio multiplies the paperwork. Article 6.2.1 e) ties every registration to a Profesional responsable and an Apoderado responsable, and the change procedure runs registration by registration. A holder with twenty registrations therefore faces twenty variation filings when a professional leaves, rather than one notification covering the portfolio. The same logic applies when an agent is replaced or a licence lapses, and it is the reason the role table should be maintained centrally while the filings are generated per registration. Where a portfolio is large, the practical sequence is to confirm the replacement professional’s CSSP licence first, then schedule the variations in batches, and only then update the powers of attorney held by distributors.

4. Practical recommendations

• Build a single role table covering the Titular, the Profesional responsable, the Apoderado responsable, the Director Técnico and the Referente de Tecnovigilancia, recording for each the source of authority, the registering body and the change procedure.
• Where a Chinese manufacturer holds the registration directly, appoint and register the Profesional responsable and the Apoderado responsable at the same time, rather than waiting for a correction request.
• Verify that both professionals hold a valid CSSP licence and place copies of the certificates in the file.
• Appoint a Referente de Tecnovigilancia for each establishment and keep a written instrument of appointment.
• When a professional or an agent changes, file the variation for each registration under Article 6.2.1 e) instead of merely issuing a new power of attorney.
• Use the Chapter 3 wording for Spanish terminology in the file, and avoid free translation of defined terms.

5. Verification checklist

• □ The five roles are tabulated with their source of authority and registering body
• □ A foreign holding structure has been confirmed and two local professionals appointed
• □ CSSP licences are valid and copies are on file
• □ A Referente de Tecnovigilancia has been appointed in writing
• □ The change procedure is designed per registration under Article 6.2.1 e)
• □ Terminology in the file matches the wording of Chapter 3

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 3.4, 3.5, 3.13, 3.29, 3.31 and 3.37, Chapter 4, and Articles 6.2.1 b) and e).

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