Three roles: registration holder, responsible professional and responsible agent

1. Key takeaways

El Salvador splits the registration subject into three separate roles, and the distinctions between them decide how a foreign manufacturer structures its local presence. The Titular del registro sanitario (registration holder, Article 3.37, defined as the owner of the product) may be a foreign entity. The Profesional responsable (responsible professional, Article 3.29) is appointed by the device owner and answers to the authority for product quality and authenticity. The Apoderado responsable (responsible agent, Article 3.4) is designated by the registration holder through a power of attorney and responds to the authority on the holder’s behalf.

Article 6.2.1 e) is the provision that turns these definitions into an operating burden: every sanitary registration must have both of the latter roles attached to it, and any replacement, whether by resignation or by revocation of the mandate, must be processed registration by registration. There is no portfolio-level substitution. A holder with a hundred registrations performs a hundred filings, and the tariff is built on the same per-registration logic.

The practical consequence is that ownership and representation can be answered separately. A manufacturer outside El Salvador can keep the registration in its own name and still meet the local-presence requirement through two licensed professionals. What it cannot do is treat those appointments as paperwork to be finalised after import begins, because the appointment is a condition attached to the registration, not to the shipment.

A second consequence concerns continuity. Article 6.2.1 e) also governs temporary absence, requiring prior written authorisation with a named substitute. Absence is therefore a filing event, not an internal HR matter, and the same holds when a professional resigns: the resignation does not take effect on the authority’s side until the change has been filed for each registration.

2. Legal basis

The three roles, the binding requirement, the duties of the responsible professional and the applicable charges are set out in the following instruments. Each row identifies the instrument, its reference number and publication date, the provision relied on and the substance of that provision.

The provisions cited in this article are Articles 3.4, 3.13, 3.29, 3.37, 6.2.1 e) and 6.2.4.2 g) of 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), and Articles 3.2.2 and 5.1 of the Tarifario de la Superintendencia de Regulación Sanitaria (2025 edition, published on the SRS website in 2025-10).

Regulatory information verified as at 29 October 2026.

3. Expert insights

Insight one: a foreign manufacturer may hold the registration directly, and the price of doing so is two local professionals. Article 3.37 defines the holder as the natural or legal person that owns the product, and the definition carries no nationality or residence condition. For a Chinese device manufacturer this is an advantage: intellectual property and registration ownership need not be transferred to a local partner to obtain market access. The trade-off is Article 6.2.1 e): each registration must carry a responsible professional and a responsible agent, and both must hold a CSSP practising licence and be registered with the authority under Articles 3.29 and 3.13.

Insight two: the three roles draw their authority from different sources, so the authorisation chain has to be designed in layers. The registration holder acts as owner. The responsible professional is appointed by the device owner. The responsible agent is designated by the registration holder through a power of attorney. Where the foreign manufacturer holds the registration itself, both appointments come from the same legal person and a single corporate resolution can support both instruments. Where the holder is a local importer, the chain forks: the professional’s mandate runs from the manufacturer abroad, while the agent’s mandate runs from the local holder. The two instruments must then be issued separately by different grantors.

Insight three: replacing a professional or an agent is a batch operation priced per registration. Article 6.2.1 e) states that whenever the responsible professional and the responsible agent are replaced, whether by resignation or by revocation of the mandate, the authority must be notified and the corresponding step taken for each sanitary registration. Article 3.2.2 of the Tarifario prices this as a base fee of USD 48.00 plus USD 0.60 for every affected registration. A holder with one hundred registrations therefore faces USD 48.00 plus USD 60.00, a total of USD 108.00 in change fees, alongside one hundred separate filings. The arithmetic matters less than the operational load, which is why the replacement should be planned as a project with a fixed cut-off date.

Insight four: temporary absence also requires prior written approval, and this is the requirement most often overlooked. The final paragraph of Article 6.2.1 e) provides that a temporary absence of the responsible professional must be notified to the authority in writing in advance for approval, with a substitute named and the instrument authorising that person to act as substitute attached. Article 6.2.4.2 g) adds a further layer for absences exceeding fifteen days, requiring five days’ advance notice together with the signatures and stamps of the two professionals. Read together, the two provisions exclude the common practice of taking leave first and completing the paperwork on return.

4. Practical recommendations

• Where the foreign manufacturer holds the registration itself, keep registration ownership and intellectual property within the offshore entity and appoint two locally licensed professionals to satisfy Article 6.2.1 e).
• Issue the authorisation documents from the two separate sources: the responsible professional’s mandate from the device owner, and the agent’s mandate from the registration holder.
• Before any replacement of a professional or an agent, calculate the change fee from the number of registrations (USD 48.00 plus USD 0.60 per registration) and estimate the filing workload on the same basis.
• Establish an absence protocol for the responsible professional, with prior written approval and a named substitute in place before any planned absence begins.
• Maintain a single master register recording the names, registration numbers and authorisation validity dates for all three roles, so that a change can be traced across the whole portfolio.
• Budget USD 48.00 under Article 5.1 of the Tarifario for the registration, amendment, resignation, revocation or termination of each power of attorney, separately from the per-registration change fee.

5. Verification checklist

• □ The identity of the registration holder is settled, whether the foreign entity holds directly or a local entity holds on its behalf
• □ A responsible professional and a responsible agent are registered against every registration in scope
• □ The CSSP practising licences of both professionals are within their validity period
• □ The authorisation documents are issued separately by the two grantors identified in Article 6.2.1 e)
• □ The cost of any planned replacement is calculated from the number of affected registrations
• □ An absence protocol exists and has been approved in writing in advance
• □ The master register of names, registration numbers and authorisation validity dates is current
• □ The fee for registering, amending, revoking or terminating each power of attorney is budgeted under Article 5.1 of the Tarifario

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