Classification Request Under Annex D

1. Key takeaways

Where a company cannot tell whether a product is a medical device or needs sanitary registration, the formal channel Nicaragua provides is Annex D of NTON 24001:2023: the DDM issues a classification certificate (Constancia de Clasificación). The documents required are only 3: the ROC payment receipt, the official application form, and the Spanish-language technical data sheet. Where the requirements are met, the certificate is issued within a maximum of 10 working days; where they are not, a rejection record (Acta de Rechazo) is issued and the applicant must file a new application rather than correct the file. Who may submit is restricted: regulated companies may only submit through a regente sanitario or a registrador, unregulated companies submit through top management, and applications submitted by customs brokers are not accepted.

2. Legal basis

The table below lists the provisions of Annex D governing submission, the three required documents, the issuing deadline and the consequence of rejection.

3. Expert insights

Point 1: The three-layer restriction on who may submit sits in the notes, but its force is not low. NOTE 1 confines submission by regulated companies to a regente sanitario or a registrador; NOTE 2 confines submission by unregulated or unregistered companies to Alta Gerencia, top management; NOTE 3 excludes customs brokers outright (No se tramitarán solicitudes de clasificación sometidas por agencias aduaneras). This means a classification application cannot be outsourced to a customs clearance agent, nor filed directly by a foreign entity.

Point 2: The NOTE to Article 2 c of Annex D carries a single sentence: No se admitirá la presentación de Hojas de Seguridad, safety data sheets are not accepted. An MSDS or SDS cannot substitute for the technical data sheet. This is the reverse of usual practice in chemical regulation, it is a requirement specific to device regulation, and it is a frequent cause of rejection of classification applications.

Point 3: The application form carries two check boxes: Clasificación unitaria, for single classification, and Clasificación múltiple, for multiple classification, the latter requiring the Tabla de Clasificación Masiva. The fields of the multiple table are generic name, trade name, intended use, brand, model or reference number, manufacturer, country of manufacture and distributor: 8 columns in all. Companies with several product lines should align all 8 columns within one application instead of filing in batches over time.

Point 4: The technical data sheet must permit identification of 6 categories of information: intended use, trade name, brand, model or reference number or code, manufacturer name, and country of manufacture. This sheet is in fact the entire factual basis on which the DDM classifies. Of the 3 documents Annex D collects, this is the only one that carries technical content. A thin sheet leads directly to rejection.

Point 5: The consequence under Article 5 differs from the registration procedure. The registration stage has pre-assessment and correction mechanisms (Chapter 7 and Annex I of RA 0007/2025); after a classification application is rejected the outcome is an Acta de Rechazo together with debiendo el interesado presentar un nuevo trámite, meaning the interested party must file a new application. There is no correction window, and fees already paid cannot be carried over to the new application.

Point 6: Article 4 of Annex D binds the classification certificate to Annex B. The conclusion is issued conforme lo establecido en el Anexo B, in accordance with what is established in Annex B. The classification certificate can therefore be used directly as the classification basis in the later registration dossier, and it connects with the principle in Chapter 5 Article 3 that ANRS classifies itself: self-classification by the company and the official ruling meet at this point.

4. Practical recommendations

• Determine the submitter qualification first: for a regulated company, confirm which regente sanitario or registrador will sign; for an unregulated company, top management signs; a customs broker never submits.
• Write the technical data sheet accurately against the 6 categories of information and in Spanish, with the intended use consistent with the official application form; do not submit an English manufacturer brochure in its place.
• Do not send safety data sheets (Hojas de Seguridad) as a supplement to or substitute for the technical data sheet.
• Use multiple classification for several products: complete all 8 columns of the multiple classification table in one pass, keeping the model, reference and code wording consistent with the later registration dossier.
• Schedule on the basis of 10 working days plus a possible new filing, and place the classification application before dossier preparation rather than in parallel with it.
• Before paying, verify the classification certificate subject in the current fee schedule of Resolución Ministerial N° 347-2023, and obtain the ROC receipt before submitting.

5. Verification checklist

• □ The submitter qualification has been confirmed against Article 1 and NOTES 1 to 3 of Annex D, and no customs broker is submitting
• □ The ROC payment receipt for the classification certificate subject under RM 347-2023 has been obtained
• □ The current version of the official application form has been completed, with the single or multiple box ticked correctly and signature and stamp affixed
• □ The technical data sheet is in Spanish and contains the 6 categories: intended use, trade name, brand, model or reference or code, manufacturer name, country of manufacture
• □ Multiple applications attach the multiple classification table with all 8 columns completed
• □ It has been confirmed that no safety data sheet (Hojas de Seguridad) has been submitted in place of the technical data sheet

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 through the regulatory directorate, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com