Government fees: the SRS Tarifario for medical devices

1. Key takeaways

The 2025 edition of the SRS Tarifario, issued by the Consejo de la SRS and signed by the Superintendent, MSc. Noe Geovanni García Iraheta, concentrates device-related charges in Section 3 for registration and changes, Section 6.2 for laboratory testing, Section 7 for imports and exports, Section 11 for establishments and Section 12.2 for GMP audits.

The core figures are as follows. Registration, renewal and upscaling are priced by number of codes or models across five tiers, at USD 150.00, 360.00, 720.00, 1080.00 and 1440.00. The annual fee is USD 25.00, the market vigilance annual maintenance fee is USD 85.00, and the import permit is USD 24.00. Article 1 provides that charges are denominated in United States dollars and are exempt from IVA, while Article 4 provides that a payment remains valid for twelve months.

Two structural features follow from that layout. Fees are charged by counting codes or models rather than by counting applications, which makes how a portfolio is bundled a direct cost decision. And the schedule is not the only source of price, because Article 5 refers matters it does not cover to separate legislation.

2. Legal basis

The charges most relevant to device holders are reproduced below as they appear in the schedule, including the percentage surcharges and the exemption provision.

The provisions cited in this article are Articles 1, 2, 3.1–3.4, 4, 5, 6.2, 7.2, 7.3, 11.1.2, 11.4, 12.2, 13.2 and 21.1 of the Tarifario de la Superintendencia de Regulación Sanitaria (2025 edition, published on the SRS website in 2025-10), and the final paragraph of Article 6.2.2 together with Articles 6.3.1 g) and 6.5.2 b) 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).

Regulatory information verified as at 29 October 2026.

3. Expert insights

Insight one: registration fees are banded by code or model count, so bundling has a direct effect on cost. Article 3.1 places obtaining a registration and marketing authorisation, renewal of a registration and changes that add codes or models within the same banded table. The first band, covering 1 to 25 codes or models, is USD 150.00, while the fifth band, covering more than 1000, is USD 1440.00. Submitting models of the same series together in one application is generally far more economical than filing them one at a time, and the saving grows with the size of the series rather than staying proportional.

Insight two: three annual payments must be identified separately. The annual fee of USD 25.00 under Article 3.3 corresponds to the obligation to maintain a registration under Article 6.3.1 g). The market vigilance annual maintenance fee of USD 85.00 under Article 3.4 applies to products that are registered, imported or domestically manufactured and currently being sold in the country. The establishment annual renewal fee, USD 36.00 for an importer and USD 480.00 for a manufacturing laboratory, corresponds to maintaining active status under the final paragraph of Article 6.2.2. Each of the three has a different trigger, and treating them as a single annual charge is how arrears arise.

Insight three: laboratory testing is banded by category across four levels, so sampling exposure can be predicted. Section 6.2 divides device testing into four bands, with disinfectants expressly named in the USD 750.00 band and other devices in the USD 1200.00 band. Read with Article 6.5.2 b), under which testing costs, including those of a third-party laboratory, are borne by the device holder, a company can estimate the cash cost of a sampling event in advance by identifying which band its product falls into. That estimate belongs in the product budget rather than in contingency.

Insight four: the two percentage provisions are the ones most often missed. Article 13.2 adds 50 per cent to the fee for expedited handling, and Article 21.1 adds 10 per cent of the initial fee for late payment, covering market vigilance maintenance fees, annual renewals and registration renewals. Article 4 adds a further constraint: a payment is valid for twelve months, and once it expires it can be neither used nor refunded. The timing of payment and the timing of submission therefore have to be aligned deliberately, because an early payment can expire before the filing is ready.

Insight five: an exemption provision and a residual provision coexist. Article 2 exempts national public institutions and international organisations that provide humanitarian assistance or promote development from paying the charges. Article 5 provides that matters not addressed in the schedule remain subject to the Ley de Tarifas por Servicios Especiales del DNM. The schedule is therefore not the only source of price, and for an individual case the amount payable is the one stated in the SRS payment notice issued at the time.

4. Practical recommendations

• Calculate the registration band from the current code or model count and assess whether bundling submissions produces a cost advantage.
• Budget the annual fee, the market vigilance maintenance fee and the establishment annual renewal fee as three separate lines.
• Estimate laboratory testing costs by product category, at USD 750.00, 1000.00, 1500.00 or 1200.00.
• Align payment and submission so that the twelve-month validity of a payment is not exceeded and the 10 per cent late surcharge is not triggered.
• Use expedited handling only where necessary, given the 50 per cent surcharge.
• Treat the schedule as a basis for estimation and confirm the amount for an individual case against the SRS payment notice issued for that file.

5. Verification checklist

• □ Registration band calculated from the current model count
• □ Three annual payments budgeted as separate lines
• □ Laboratory testing fee estimated by category
• □ Payment and submission timing aligned within the twelve-month validity period
• □ Expedited and late-payment risks assessed
• □ Amount for the individual case confirmed against the payment notice
• □ Applicability of the Article 2 exemption considered where a public or international body is involved

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