Five-Year Registration Validity and Annual Fee: Articles 6.3.1 f) and g)

1. Key takeaways

Article 6.3.1 f) of RTS 11.03.02:21 provides that sanitary registration is valid for 5 years and must be renewed 6 months before expiry, or at the latest within 3 months after expiry, failing which the registration is suspended and cancellation proceedings begin. Article 6.3.1 g) adds that during the five-year term an annual fee (anualidad) must be paid year by year, and that non-payment likewise leads to suspension and cancellation. In the 2025 edition of the Tarifario these become three different payments: registration or renewal from USD 150.00 under Section 3.1.1 for 1 to 25 codes or models, the annual fee of USD 25.00 under Section 3.3, and the market vigilance annual maintenance fee of USD 85.00 under Section 3.4.

The first thing to establish is that these three amounts answer three different questions. One buys the registration for a five-year term, one keeps it alive year by year, and one covers the post-market maintenance obligation attached to products actually on the market. Treating the total as a single licence cost obscures which payment has been missed when a suspension notice arrives, and the recovery steps differ for each.

2. Legal basis

The validity term, the annual fee, the tiered registration fee and the late payment surcharge are set out in the following provisions.

3. Expert insights

Insight 1: The five-year validity and the annual fee are two independent failure paths. Item f) governs expiry of the term, while item g) governs payment within the term. Article 6.3.3 a) then makes a valid registration with the annual fee paid a precondition for any post-registration change and for renewal. The combined effect is severe: even where a registration number is still well within its five-year term, a single missed annual payment suspends the registration, and in that suspended state neither a change nor a renewal can be filed. The company is therefore locked out of the very procedures it would use to regularise its position until the arrears are cleared.

Insight 2: The registration fee is tiered across five brackets by code or model count, and this is the basis for any bundling strategy. Section 3.1 of the tariff divides filings into 1 to 25, 26 to 100, 101 to 500, 501 to 1000 and over 1000, corresponding to USD 150.00 up to USD 1440.00. Section 3.1 applies to obtaining the sanitary registration and marketing authorisation, to renewal, and to a change of registration caused by adding codes or models. Renewal and extension are therefore priced on the same scale, which means bundling several models into one application is usually more economical than filing model by model, but only within the bracket boundaries.

Insight 3: The annual fee and the market vigilance maintenance fee are two separate items and should not be declared together. The annual fee of USD 25.00 in Section 3.3 corresponds to the registration maintenance obligation in Article 6.3.1 g). The market vigilance annual maintenance fee of USD 85.00 in Section 3.4 applies to products that are registered, imported or domestically manufactured and are currently being sold in the country. The latter is triggered by actual sale on the market, the former by the mere existence of the registration, so the two conditions can diverge: a registered product that is not being sold still owes the annual fee but does not attract the vigilance maintenance fee.

Insight 4: Late payment attracts a 10 per cent surcharge, and the payment receipt itself is only valid for 12 months. Section 21.1 of the tariff adds 10 per cent, calculated on the initial fee, to late payment of the market vigilance maintenance fee, the annual renewal and the registration renewal. Article 4 then provides that where a payment is not applied within 12 months of being made, it can neither be used again nor refunded. The two rules together require the payment and the filing to move on the same rhythm; paying a year early does not reserve a slot, it simply wastes the receipt.

4. Practical recommendations

• Set two independent reminders, one for the 5-year expiry dated 6 months ahead and one for the annual fee dated year by year.
• For multi-model products, calculate the bracket from the code or model count and assess whether a bundled filing is more economical.
• Declare the annual fee and the market vigilance maintenance fee separately, and first confirm whether the product is actually being sold in the country.
• Align the payment and filing rhythm so that the receipt does not exceed its 12-month validity and the 10 per cent late surcharge is not triggered.
• Before filing any change or renewal, confirm that the annual fee is paid, as required by Article 6.3.3 a).
• Maintain one master ledger recording the registration number, the expiry date, the annual fee due date and the market vigilance fee due date.

5. Verification checklist

• □ Registration number and 5-year expiry date entered in the ledger
• □ Annual fee reminder set on an annual cycle
• □ Multi-model bracket and bundling strategy calculated
• □ Annual fee and market vigilance fee declared separately
• □ Payment and filing rhythm aligned within the 12-month receipt validity
• □ Annual fee confirmed as paid before any change is filed

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