Certificate Replacement Under Annex F in Nicaragua

1. Key takeaways

Where a registration certificate is lost or damaged, a replacement (reposición) is requested under Annex F of NTON 24001:2023. The filing is made on a working day either by a registrador, which may be a regente sanitario or an authorised freelance registrador, or by the legal representative of the manufacturer. The file contains two documents: the ROC payment receipt under the heading for replacement of approved matters, and the official application form in its current version. Where the requirements are met, the certificate is issued within a maximum of ten working days; where they are not, an Acta de Rechazo is issued and the application must be filed again.

• Replacement is a two-document procedure under Annex F, with no technical review.
• The filing may be made by a registrador or by the manufacturer’s legal representative.
• The fee heading is replacement of approved matters, which is distinct from registration and renewal fees.
• Issuance takes a maximum of ten working days where the file is compliant.
• A rejected file produces an Acta de Rechazo and requires a fresh submission, with no correction window.
• Replacement does not change the registration number or the validity period.

2. Legal basis

Annex F is normative and sets out the procedure in five articles, from the person entitled to file through to the consequence of a rejected application.

3. Expert insights

The first point is who may file. Annex F allows a registrador, defined in the article as a regente sanitario or an authorised freelance registrador, or the legal representative of the manufacturer. That is broader than the CLV rule in Annex E, which is limited to the regente sanitario, and broader than product registration, which must be filed by a registrador: Annex F adds the manufacturer’s legal representative as a second channel.

The second point is the fee heading. “Reposición de Trámites ya Aprobados”, replacement of approved matters, is a heading of its own, separate from those used for registration, renewal, classification certificates and the CLV. The same heading appears in article 5 of Chapter 12, where a further correction request is filed, and in article 10, paragraphs 4 and 5 of Annex I of RA 0007/2025 for licence corrections. It is the common Nicaraguan fee category for changes to matters that have already been approved.

The third point is the size of the file. Two documents place Annex F at the same level as Annex E for the CLV, making these the two simplest of the normative annexes to NTON 24001. Replacement is a status procedure and does not involve technical evaluation, which is why the document set is limited to proof of payment and a completed form. The absence of any product documentation also means the file can be assembled without input from the manufacturing site, provided the authorised signatory is available.

The fourth point is the consequence of a defective filing. Article 5 of Annex F produces a new submission rather than a correction window. That matches Annex D for classification and Annex E for the CLV: at annex level, NTON procedures generally do not provide a period in which to remedy defects.

The fifth point is continuity. The replacement replaces the certificate itself and does not change the registration number or the validity period. The unique and permanent number in Chapter 7, article 6 and the five-year term in Chapter 11 are unaffected, and the renewal window continues to run from the original date of grant.

The sixth point is what the text does not require. There is no requirement for a newspaper notice, a statement of loss or a police report. This guide treats those documents as not required and does not prepare them; if DDM asks for one in an individual case, its position governs.

4. Practical recommendations

• Decide who will file: either a registrador, including a regente sanitario or an authorised freelance registrador, or the manufacturer’s legal representative.
• Pay under the heading for replacement of approved matters and obtain the ROC receipt, as required by Annex F, article 2 a.
• Use the current version of the official application form, completed, signed and sealed, as required by Annex F, article 2 b.
• Schedule against a maximum of ten working days and plan for a fresh submission if the file is rejected.
• Leave the registration number and validity period unchanged in the register, since replacement does not reset either and the renewal window still runs from the original grant.
• Do not prepare newspaper notices or statements of loss, which the text does not require, unless DDM asks for them in the individual case.

5. Verification checklist

• □ The filing party is confirmed as either a registrador or the manufacturer’s legal representative.
• □ Payment has been made under the replacement of approved matters heading and the ROC receipt obtained.
• □ The official application form is the current version, completed, signed and sealed.
• □ The schedule allows a maximum of ten working days and a fresh submission if rejected.
• □ The registration number and validity register has not been reset, and the renewal window still runs from the original grant.
• □ No newspaper notice or statement of loss has been prepared beyond what the text requires.

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