Special import: the eight situations under Article 6.4.2

1. Key takeaways

Article 6.4.2 a) of RTS 11.03.02:21 lists eight situations that qualify for special import (importación especial): 1) devices intended for scientific research where the protocol has already been approved; 2) devices purchased through the PAHO/WHO procurement mechanism; 3) devices for personal or company use; 4) product samples; 5) diplomatic use; 6) supply to the national integrated health system; 7) donations; 8) public health emergencies.

The remaining items of the same article apply regardless of which situation is invoked. b) requires a remaining shelf life of not less than six months, with conditional treatment available in special cases. c) requires the absence of a valid health alert. d) requires the payment reference number. e) requires the application form, the invoice signed and stamped by the responsible professional, and the additional documents that correspond to the type of permit being sought.

The common thread across the eight situations is that the goods do not enter through the ordinary commercial channel. That does not mean they enter without authorisation. Every case still requires a per-consignment authorisation and the same underlying conditions, which is the point most often misread by suppliers who assume that a sample or a donation can simply be shipped.

2. Legal basis

The eight situations, the conditions attached to them and the two fee levels that apply depending on commercial use are set out below.

The provisions cited in this article are Articles 6.1.1 d) and 6.4.2 a)–e) 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 7.2 and 7.3 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: what the eight situations have in common is the absence of an ordinary commercial route, not the absence of authorisation. The heading of Article 6.4.2 is the requirements for a special import authorisation, and items b) to e) apply in full to every one of the eight situations. The two situations most often misunderstood are item 3, personal or company use, and item 4, product samples. Both sound as though the goods can simply be sent, yet both still require an authorisation application for each consignment. Treating either as a courier matter rather than a regulatory filing is the single most common cause of goods being held on arrival.

Insight two: the six-month threshold in item b) adds a conditional mechanism that routine import does not have. Article 6.4.2 b) states the six-month requirement and then adds the phrase save in special cases, explaining that the requirement is conditional on the responsibility of the person carrying out the procedure and on the corresponding authorisation by the authority. This creates room to apply for donations of short-dated product, but the responsibility sits with the applicant and an explicit authorisation must be obtained. A supplier cannot decide unilaterally that a case is special; the exception exists only once it has been granted.

Insight three: the special import invoice carries nine items rather than ten. The fields required on a special import invoice are product name, batch or serial number, expiry date where applicable, quantity, presentation, manufacturer, country of origin, unit price and total price, nine items in all, with no registration number. The signature requirement is also narrower, covering only the device’s responsible professional rather than both that professional and the importing establishment. This corresponds precisely to the scenario the route was designed for, in which the product being imported may not yet hold a registration and therefore has no registration number to quote.

Insight four: the fee has two levels depending on commercialisation, and the application must state which one applies. Article 7.2 of the Tarifario prices the import permit or special import permit for non-commercial purposes at USD 24.00, while Article 7.3 prices the special import permit for commercialisation at USD 250.00. The same application form therefore carries very different cost consequences depending on the stated purpose, and the difference between the two figures is more than tenfold. The purpose must be written clearly in the application, because the fee that is assessed follows from that statement.

4. Practical recommendations

• Match the consignment to one of the eight situations under Article 6.4.2 a) before preparing documents, then assemble the additional documents that correspond to that situation.
• Where a short-dated donated product needs to go below the six-month threshold, apply expressly and accept responsibility in writing rather than assuming the exception.
• Issue the special import invoice with the nine prescribed fields and no registration number, signed and stamped by the responsible professional.
• State in the application whether the goods are for commercialisation, so that the correct fee under Article 7.2 (USD 24.00) or Article 7.3 (USD 250.00) is assessed.
• For research devices, obtain ethics approval and the authority’s authorisation before applying for the special import.
• For the public health emergency situation, keep the official declaration of emergency on file as the evidential basis for relying on that situation.

5. Verification checklist

• □ The import situation has been mapped to one of the eight categories
• □ The shelf-life threshold has been addressed under item b), including any special-case application
• □ The invoice carries all nine prescribed fields with signature and stamp
• □ Commercialisation status is stated in the application
• □ Ethics approval and authorisation are in place for research devices
• □ The emergency declaration is on file where the eighth situation is relied on
• □ The payment reference number is available for submission under item d)

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