Three Authorisations Before Market: Establishment, Sanitary Registration, Import Authorisation

1. Key takeaways

El Salvador places three authorisations between a medical device and the market, and they operate in strict sequence. The first is the establishment authorisation under Article 6.2, which presupposes a lawful importer, distributor or storage establishment. The second is the sanitary registration under Article 6.3, which operates at product level and runs for a validity of 5 years. The third is the import authorisation under Article 6.4, which is handled shipment by shipment. The order cannot be reversed, and it cannot be compressed. Article 6.4.1 a) makes import conditional on the registration being valid and its annual fee paid. Article 6.4.1 b) makes the same transaction conditional on the establishment applying for import being registered as a device importer with its annual fee paid.

The consequence is cumulative rather than additive. A device may hold an unexpired registration number and still be unimportable, because the establishment behind the application has lapsed. Equally, an establishment may be fully authorised and current and still be unable to move a single unit, because the product has no registration. Each layer has its own fee, its own renewal cycle and its own failure mode, and none of them substitutes for another. Planning that treats the registration dossier as the project and the establishment file as an administrative preliminary is the single most common source of delay in this market.

2. Legal basis

The three authorisations, their conditions and their fee lines are set out in the following provisions of RTS 11.03.02:21 and the 2025 SRS fee schedule.

3. Expert insights

Insight 1: The three authorisations are serial, and the material of the earlier one is the precondition of the later one. Articles 6.4.1 a) and b) place a valid registration and a current importer registration with fees paid side by side as conditions of the import authorisation, while Article 6.2.1 f) requires the importer itself to be one of the 5 regulated establishment categories holding an authorisation. The effect is that a lapse at any layer blocks every downstream action. This is not limited to new products. A device that has held its registration number for years becomes unimportable the moment the establishment annual fee is unpaid, because the import authorisation is assessed against the current state of the establishment and not against the history of the file.

Insight 2: The sequence cannot be short-circuited by running the workstreams in parallel. Many companies attempt to file the product dossier while the establishment authorisation is still in progress, on the assumption that the two tracks will converge. Article 6.2.1 c) requires the Director Técnico, the Profesional and the Apoderado to be registered with the competent authority, and the registration dossier under Article 6.3.2.1 depends on those registrations being in place. Filing early therefore does not save time; it converts a clean submission into an office action in which the missing role registrations have to be supplied. The GRZAN approach is to lock the establishment and the three named roles first, and only then file the product dossier, so that any request for correction concerns the product file itself.

Insight 3: Products without registration are not entirely excluded from the country, but they travel through an independent channel. Article 6.4.2 creates a special import route (importación especial) for 8 situations: research with an approved protocol, procurement by PAHO or WHO, personal or corporate own use, samples, diplomatic use, use by the national integrated health system, donations, and public health emergencies. This channel is defined by its purposes, not by commercial convenience. The very fact that a separate route had to be created for these eight cases is the clearest evidence that routine commercial import must first complete the establishment authorisation and the sanitary registration. A distributor who describes an ordinary sale as a donation or as samples moves from a procedural question into an enforcement question.

Insight 4: The fees for the three authorisations sit in three different chapters of the tariff, so budgets must be built in three lines rather than one. In the 2025 edition of the Tarifario, importer registration appears in Section 11.4 (registration USD 72.00, annual renewal USD 36.00), product registration appears in Section 3.1 (USD 150.00 for 1 to 25 codes or models), and the import permit appears in Section 7.2 (USD 24.00, with the special import for commercialisation purposes falling under Section 7.3 at USD 250.00). Collapsing these into a single registration fee is the most frequent error in project budgets, and it usually surfaces at the worst moment, when the shipment is already at the border and the import permit line has never been funded.

4. Practical recommendations

• Schedule the project as a serial chain: establishment authorisation, then registration of the three named roles, then sanitary registration, then import authorisation for each shipment. Do not run the tracks in parallel.
• Do not file the product dossier before the importer establishment authorisation is granted, so that missing role registrations do not turn into an office action.
• Consolidate the annual fee payment dates of all three authorisations into a single annual payment calendar, because a missed payment at any layer stops imports.
• Build the budget against the three tariff chapters separately: Section 11.4 for the establishment, Section 3.1 for the product, and Sections 7.2 and 7.3 for import.
• If an unregistered product must enter the country, use the special import route of Article 6.4.2 and prepare the additional documents required for the specific situation relied on.
• Before each shipment, verify three points at once: the registration number is valid, the annual fee is paid and the importer establishment is active. All three are required and none of them compensates for another.

5. Verification checklist

• □ Establishment authorisation obtained and in active status
• □ Director Técnico, Profesional and Apoderado registered
• □ Sanitary registration obtained and annual fee paid
• □ Importer establishment registered as a device importer
• □ Annual payment calendar covering all three authorisations established
• □ Budget presented in three separate tariff chapters

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