Annual fees, suspension and cancellation of registrations

1. Key takeaways

Article 6.3.1 g) of RTS 11.03.02:21 provides that, in order to maintain the validity of a sanitary registration over its five-year term, the applicant must pay the annual fee (anualidad); otherwise the registration will be declared suspended and the cancellation procedure will be initiated.

Article 6.3.1 f) establishes a parallel route to the same outcome: where the registration reaches the end of its five-year term and renewal has not been processed within the preceding six months or at the latest within three months after expiry, the registration is likewise suspended and cancellation is initiated. Article 6.3.3 a) then makes a valid registration with the annual fee paid a precondition for carrying out any post-registration change or renewal at all.

The two provisions therefore create two independent locks on the same door. Losing either one produces the same legal consequence, and the consequence is broader than the loss of the registration itself, because the registration status is what enables import, amendment and renewal.

2. Legal basis

The maintenance obligation, the renewal deadline, the knock-on conditions for import and changes, and the applicable fees and surcharges are set out below.

The provisions cited in this article are Articles 6.3.1 f) and g), 6.3.3 a) and 6.4.1 a) 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 3.3, 3.4, 4, 21.1.2 and 21.1.4 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 annual fee and the renewal are two independent locks, and failure of either produces the same result. Articles 6.3.1 f) and g) use identical language for the consequence, namely that the registration is suspended and the cancellation procedure is initiated. The difference lies only in the trigger: item f) is concerned with the expiry of the term without renewal, while item g) is concerned with non-payment of the annual fee during the term. Combining the two into a single reminder is the practice most likely to produce a missed payment, because the two obligations fall due at different points in the cycle and are discharged by different filings.

Insight two: the knock-on effect of suspension is wider than the loss of the registration. Article 6.4.1 a) makes payment of the annual fee a mandatory condition for routine import, and Article 6.3.3 a) makes it a precondition for changes and renewals. Once suspension occurs, the holder therefore loses three things at the same time: the right to import, the right to amend and the right to renew. Restoring the position costs far more than paying on time, because the loss of import capability interrupts supply while the administrative steps are completed.

Insight three: the USD 25.00 annual fee corresponds to keeping the registration alive, while the USD 85.00 market vigilance fee corresponds to selling in the market. The annual fee under Article 3.3 of the Tarifario corresponds to the obligation in Article 6.3.1 g). The market vigilance annual maintenance fee under Article 3.4 applies to products that are registered, have been imported or are domestically manufactured, and are currently being sold in the country. The triggers differ: a product that is registered but not yet actually sold is subject to the former and not yet to the latter, which is why a single combined payment calendar misstates the obligation for products still in pre-launch.

Insight four: late payment carries a 10 per cent surcharge calculated on the initial fee. The late surcharge under Article 21.1.2 for annual renewal and under Article 21.1.4 for registration renewal is both calculated as 10 per cent of the value of the initial fee rather than of the amount outstanding. Taken with the twelve-month validity of payments under Article 4, the timing window matters more than the amount itself: a payment made too early can expire before it is applied, while a payment made too late attracts a surcharge computed on a figure that does not shrink.

4. Practical recommendations

• Set the annual fee and the renewal as two separate reminders, the first recurring annually and the second raised six months before expiry.
• Assess the annual fee and the market vigilance maintenance fee separately: the first follows the existence of the registration, the second follows actual sale in the market.
• Build a suspension risk alert that flags the simultaneous loss of import, amendment and renewal rights if either obligation lapses.
• Treat on-time payment as a hard financial control point, since the late surcharge is calculated on the initial fee at 10 per cent.
• Complete the step that the payment supports within twelve months, so that the payment does not expire unused.
• Maintain a single master register showing the registration number, expiry date, annual fee payment date and market vigilance fee payment date.

5. Verification checklist

• □ Annual fee and renewal set as two separate reminders
• □ Annual fee and market vigilance fee assessed on separate triggers
• □ Suspension risk alert in place, covering the three affected rights
• □ The 10 per cent late surcharge built into financial control points
• □ Completion within twelve months of payment reflected in the schedule
• □ The four key dates consolidated in a master register
• □ Renewal filed within the six-month window before expiry and no later than three months after

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