Import authorisation: six conditions under Article 6.4.1 and ten invoice fields

1. Key takeaways

Article 6.4.1 of RTS 11.03.02:21 sets six conditions for routine import, meaning import of devices that already hold a sanitary registration. a) The device must have a sanitary registration, its annual fee must be paid and its renewal must be in force. b) The establishment applying to import must be registered as a device importer and its annual fee must be paid. c) The device must have a remaining shelf life of not less than six months. d) There must be no valid health alert constituting a threat to public health. e) The original and a copy of the invoice must be submitted, signed and stamped by the device’s responsible professional and by the authorised importing establishment, and the invoice must carry ten items of information. f) The importer must keep batch release certificates of analysis available for retrieval in the course of vigilance.

The six conditions are not a single test applied to a single party. They are distributed across the product, the establishment, the condition of the goods and the shipment documents, and a failure at any one of those points stops the consignment at the border regardless of how strong the others are. This is why the routine import check is best run as a four-part review rather than as a document checklist alone.

Two of the conditions carry a fee dimension that is easy to overlook. The annual fee attached to the product registration and the annual fee attached to the establishment registration are separate charges with separate triggers; paying one does not satisfy the other. The import permit itself is priced separately at USD 24.00 under Article 7.2 of the Tarifario.

2. Legal basis

The six conditions, the invoice content requirements and the applicable charge are set out in the following provisions.

The provisions cited in this article are Articles 6.4.1 a)–f) and 6.4.2 c) and 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 Article 7.2 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: the six conditions sit on three different parties, and any gap blocks the shipment. Item a) concerns the product side, namely the registration and its annual fee. Item b) concerns the establishment side, namely the importer registration and its annual fee. Items c) and d) concern the state of the goods, namely shelf life and alert status, while items e) and f) concern documentation. In practice the most frequent obstacle is the pair of annual fees in a) and b): the product annual fee and the establishment annual fee are two different payments, and a lapse in either will stop a product that has already been approved from entering the country.

Insight two: the ten invoice items are prescribed by the regulation, and two signatures are required. Article 6.4.1 e) lists the following ten elements: product name, sanitary registration number, presentation, manufacturer, country of origin, batch or serial number, expiry date where applicable, quantity, unit price and total price. The signature requirement covers two parties, the device’s responsible professional and the authorised importing establishment. Note the difference from the special import invoice under Article 6.4.2 e): that invoice does not require a registration number and carries nine items instead of ten.

Insight three: requiring an original and a copy of the invoice implies an on-site check. The wording is original and copy of the invoice. The operational effect is that the authority stamps and retains the copy while returning the original, so that the transaction leaves a trace at the point of release. It also means the invoice has to be produced afresh for each consignment; an annual contract cannot stand in for it, because the document must correspond to the specific batch and the specific shipment being released.

Insight four: the phrase threatening public health in item d) is a limiting qualifier. Article 6.4.1 d) refers to the absence of a valid health alert constituting a threat to public health, whereas Article 6.4.2 c), which applies to special imports, refers only to the absence of a valid health alert with no such qualifier. The two thresholds are therefore not identical. The alert screening for routine imports is narrower and reaches only alerts that threaten public health, while the special import route covers any valid alert.

4. Practical recommendations

• Before shipment, verify three status points: the product registration and its annual fee, the importer establishment registration and its annual fee, and the alert status of the product.
• Issue the invoice with the ten items required by Article 6.4.1 e), and have it signed and stamped by both the responsible professional and the importing establishment.
• Prepare the original and a copy of the invoice for each consignment rather than relying on an annual contract.
• Screen alerts for routine imports against the question of whether the alert threatens public health, and for special imports against the broader question of whether any valid alert exists.
• File batch release certificates of analysis by batch so that they can be produced at short notice during vigilance activity.
• Budget USD 24.00 per import permit under Article 7.2 of the Tarifario, and keep the payment reference with the shipment file.

5. Verification checklist

• □ Product registration and annual fee status confirmed
• □ Importer establishment registration and annual fee status confirmed
• □ Invoice carries all ten prescribed items with both signatures and stamps
• □ Original and copy of the invoice prepared for the consignment
• □ Alert status screened against the correct threshold for the chosen import route
• □ Batch release certificates of analysis filed by batch
• □ Import permit fee of USD 24.00 paid and documented

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