Government Fees and Ministerial Resolution 347-2023

1. Key takeaways

Nicaraguan device registration fees are not priced in NTON 24001:2023 itself. Chapter 5, Article 10 of the standard refers to the applicable legal norms, and in practice the schedule sits in Ministerial Resolution No. 347-2023. The official PDF examined for this review is a 24-page scan without a text layer, so the amounts cannot be verified line by line, and this article therefore lists no figures: amounts follow the official publication in force at the time. What can be verified is the set of five payment nodes and the receipt rule. Registration processing, renewal, first-marketing quality testing, the classification certificate and the CLV each carry their own payment item, all are evidenced by a ROC receipt, and the receipt remains valid for a maximum of six months from the date of payment.

• The fee schedule is set by RM 347-2023, not by the technical standard (Chapter 5, Article 10).
• Amounts must be taken from the official publication in force; the scanned PDF does not permit line-by-line verification.
• Five payment nodes exist: registration, renewal, first-marketing testing, classification certificate and CLV.
• A ROC receipt is the evidence of payment at every node (Chapter 6, item 1).
• Every ROC receipt is valid for six months from payment (Chapter 6, item 1; Chapter 8, Article 1 b).
• A cancellation voids the payment and requires a fresh one (RA 0007/2025, Anexo I, Article 12 item 3).

2. Legal basis

The fee structure is built in three layers: the technical standard authorises charging, the ministerial resolution prices the services, and individual provisions identify when payment is due. The table sets out each layer.

3. Expert insights

Insight one: the fee chain has three links. NTON Chapter 5, Article 10 authorises the charge; RM 347-2023 sets the price; the individual provisions identify the moment of payment. The standard dates from 2023 and the schedule can be updated independently, which explains why no amount appears anywhere in the body of the standard — it says only that payment must be made as required by law.

Insight two: the five payment nodes are separate items. Registration processing (Chapter 6, item 1), renewal (Chapter 8, Article 1 b), first-marketing quality testing (Chapter 7, Article 8), the classification certificate (Annex D, Article 2 a) and the CLV (Annex E, Article 2 a) are budgeted separately rather than folded into a single registration charge.

Insight three: the treatment of amounts here is deliberate omission, not estimate. Because the official PDF is a scan without a text layer, line-by-line verification cannot be completed, and quoting an unverified figure would breach the principle that every statement must be checkable. The gap is left open on purpose rather than filled with an approximation.

Insight four: the six-month validity is the only timing rule, and it applies uniformly. Chapter 6, item 1 and Chapter 8, Article 1 b are drafted in identical terms. Once the receipt expires there is no extension mechanism; payment has to be made again.

Insight five: a cancellation voids the payment already made. Article 12 item 3 of Anexo I to RA 0007/2025 states «deberá iniciar uno nuevo iniciando con el pago del arancel correspondiente» — a new procedure must be started, beginning with payment of the corresponding fee. Fee management and correction-deadline management are therefore the same task, and a missed correction deadline costs more than time.

Insight six: one concrete amount is verifiable in the current texts. Article 24 of Anexo I to RA 0001/2026 sets a fee of C$364.74 (Nicaraguan córdobas) where correction of a power is requested more than five working days after approval has been withdrawn. It is the only specific amount verified here, and it confirms that the schedule is denominated in córdobas.

4. Practical recommendations

• Take amounts only from the RM 347-2023 publication in force; do not use historical figures or third-party restatements.
• Budget by the five nodes — registration, renewal, first-marketing testing, classification certificate and CLV — rather than as one lump sum.
• Log the payment date and set a six-month expiry reminder (Chapter 6, item 1; Chapter 8, Article 1 b).
• Monitor ROC validity during any correction phase, since a cancellation means paying again.
• Schedule payment after the dossier is complete and before submission, so the receipt does not expire during review.
• Where a power needs correction at a cost of C$364.74, file within five working days of the withdrawal of approval to avoid it (RA 0001/2026, Anexo I, Article 24).

5. Verification checklist

• □ All amounts are taken from the RM 347-2023 publication in force, with no historical figures used
• □ The budget is split across the five nodes: registration, renewal, first-marketing testing, classification certificate and CLV
• □ The payment date is logged and a six-month expiry reminder set
• □ ROC validity is monitored during corrections to avoid cancellation and a second payment
• □ Payment is scheduled after the dossier is complete and before submission
• □ Any power correction was filed within five working days, avoiding the C$364.74 fee

Regulatory information verified as of 29 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Nicaraguan market. Our team manages Ministry of Health (MINSA) sanitary registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com