The Official Application Form: Information on Five Parties

1. Key takeaways

Item 2 of Chapter 6 of NTON 24001:2023 divides the content of the official application form into twelve blocks (a to l). Five of those blocks carry party information: the manufacturer (f), the registration holder (g), the legal manufacturer (h), the importer or distributor (j) and the applicant (l). The remainder cover the type of procedure and product identification (a to d), the device description (e, seven items), the manufacturer’s legal representative (i) and the distributor’s legal representative (k). The same form serves new registration, renewal and post-registration changes.

• The form is structured in twelve blocks, of which five are dedicated to identifying the parties in the registration chain.
• Manufacturer (f) and legal manufacturer (h) are separate concepts: one is the production site, the other bears legal responsibility for the product.
• The holder block (g) requires five basic items and does not demand a Nicaraguan address, consistent with the definition of Titular as the party granting the authorisation.
• For IVD products, the shelf-life field must give two figures: the life in sealed condition and the life once opened.
• The applicant block (l) requires the código sanitario issued by ANRS and must match the holder of the Karplus account.

2. Legal basis

The table below follows the block structure of item 2 of Chapter 6. Reading the form in this order makes clear which blocks describe the product and which describe the parties, and it shows where the form intersects with Chapter 5 on responsibilities and with RA 0007/2025 on who may file.

3. Expert insights

Insight 1: “manufacturer” and “legal manufacturer” are two different parties. Block f asks for information on the production site, while block h identifies the party that bears legal responsibility. Article 7 of Chapter 5 assigns legal, technical and scientific responsibility for the product to the legal representative of the legal manufacturer, which corresponds precisely to block h. Under a maquila arrangement the two blocks are not completed with the same company, and an error here will cause the authorisation chain to fall out of alignment.

Insight 2: the holder block (g) requires only five basic items and does not require an address in Nicaragua. This echoes item 41 of the definitions in Chapter 4, which defines the Titular as the party granting the authorisation: the holder may be a foreign entity, while responsibility within the country rests with the legal representative and the applicant.

Insight 3: for IVD products the shelf-life field takes two figures. Sub-item e.iv requires la vida útil del producto sellado y una vez abierto, that is, the life in the sealed state and the life once opened. This field is specific to IVD products, and a single figure will be returned.

Insight 4: two licence-number fields are aimed at different parties, the domestic manufacturer and the importer or distributor, and both require an expiry date. Fields f.vi and j.vi are the direct basis on which DDM verifies the right to trade, and they are the key fields for judging whether the trading licence covers the activity applied for.

Insight 5: the applicant block (l) requires the código sanitario, which connects with Article 5, sub-items e and g, of Annex I to RA 0007/2025: registration must be handled by a health sciences professional holding a power of attorney approved by SAJ and holding a Karplus account. The applicant named on the form must be the same person who holds the account.

Insight 6: one form covers three types of procedure. Block a requires a choice between new registration, renewal and post-registration change, which means that renewals and changes reuse the same form. When maintaining product master data, companies should preserve exactly the wording used at first submission, so that the same product does not acquire two versions of its information at different stages. Divergence of this kind is a common reason for rejection of post-registration changes and renewals.

4. Practical recommendations

• Keep blocks f and h distinct: under a maquila arrangement, enter the production site and the party bearing legal responsibility separately, consistent with the SAJ-approved contract required by item 11 of Chapter 6.
• Complete the holder block in line with item 41 of the definitions, naming the party that actually grants the authorisation; a foreign entity is acceptable and no domestic address is needed.
• For IVD products, give both shelf-life figures, sealed and after opening, in block e.iv.
• Verify both licence numbers and expiry dates: f.vi for a domestic manufacturer, j.vi for the importer or distributor.
• The name and código sanitario entered in the applicant block must match the Karplus account holder and the applicant power approved by SAJ.
• Build a product master data sheet that preserves the wording of the first submission for reuse in renewals and post-registration changes.

5. Verification checklist

• □ The manufacturer (f) and legal manufacturer (h) blocks have been distinguished, and under maquila they match the contract required by item 11 of Chapter 6
• □ The holder block (g) names the party actually granting the authorisation, in line with item 41 of the definitions
• □ For IVD products, the shelf life is stated separately for the sealed state and after opening (e.iv)
• □ The sanitary licence numbers and expiry dates of the manufacturer and of the importer or distributor have been entered and checked
• □ The applicant name and código sanitario have been reconciled with the Karplus account holder and the SAJ-approved applicant power
• □ A product master data sheet exists so that renewal and post-registration change submissions reuse identical fields

Related reading: [The six-month validity of the ROC payment receipt](/nicaragua-medical-device-registration/roc-payment-receipt-six-month-validity/) | [Three SAJ approvals: legal representative, registration professional, distribution authorisation](/nicaragua-medical-device-registration/three-saj-approvals-for-powers/) | [Who is the Titular: item 41 of the definitions and foreign entities](/nicaragua-medical-device-registration/who-is-the-registration-holder/)

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