Contract Manufacturing and Maquila: Contracts, Quality Agreements and Re-registration

1. Key takeaways

Contract manufacturing in Nicaragua is anchored in Chapter 6, item 11 of NTON 24001:2023. The applicant must submit a copy of the manufacturing contract or quality agreement between the product owner and the contract manufacturer, approved by the legal advisory office of ANRS (SAJ). Contract manufacturing is not a route around registration: changing the contract manufacturer is listed in Chapter 9, item 18 b among the situations that require a new registration, alongside a change of manufacturer. Three parties have to be kept apart throughout — the product owner, the legal manufacturer and the contract manufacturer — because the application form records them in different fields and the contract itself is concluded between two of them only.

• A copy of the manufacturing contract or quality agreement, approved by SAJ, is the filing document (Chapter 6, item 11).
• The contract is concluded between the product owner and the contract manufacturer.
• Changing the contract manufacturer triggers a new registration (Chapter 9, item 18 b).
• Each manufacturing plant is registered separately (Annex C, C.1 e).
• The legal manufacturer, not the contract manufacturer, remains the responsible party (Chapter 5, Article 7).
• A quality agreement may replace the manufacturing contract, but it too requires SAJ approval.

2. Legal basis

The provisions below are drawn from the technical standard, with one administrative resolution touching the authorisation arrangements between the parties.

3. Expert insights

Insight one: a copy is required, but only of an approved document. Chapter 6, item 11 asks for a copy rather than an original, on the condition that the document has been approved by SAJ. Approval runs on the original and filing runs on the copy, in the same way as the powers dealt with in Chapter 6, items 4, 5 and 6. Understanding this saves the preparation of originals that will not be accepted at the counter.

Insight two: the contracting parties are the product owner and the contract manufacturer. The text reads «entre el propietario del producto y el manufacturador». This maps onto two different fields of the application form: item f for the manufacturer or production site, and item h for the legal manufacturer or responsible entity. Under a contract manufacturing arrangement the three parties are distinct, and this is where the form is most often completed wrongly.

Insight three: changing the contract manufacturer equals a new registration. Chapter 9, item 18 places «Cambio de manufacturador por contrato» and «Cambio de fabricante» as the first two of the five situations requiring re-registration. A contract manufacturer is not a supplier that can be swapped at will; the cost of the change is equivalent to registering a new product.

Insight four: Annex C tightens the same point from another direction. Rule C.1 e states «Se deberá efectuar un registro por cada planta de fabricación que elabore el producto» — one registration per manufacturing plant. A change of contract manufacturer therefore both triggers re-registration under Chapter 9, item 18 b and alters the basis on which device families are grouped under Annex C.

Insight five: a quality agreement may be used instead of a contract. Chapter 6, item 11 allows «contrato de manufactura o acuerdo de calidad» as alternatives. For a principal that does not wish to disclose commercial terms, the quality agreement is the more common route, and it is subject to the same SAJ approval.

Insight six: responsibility does not shift with the manufacturing arrangement. Chapter 5, Article 7 places product responsibility on the legal representative of the legal manufacturer. The contract manufacturer does not become the responsible party under Nicaraguan law by virtue of producing the device, which determines how the responsibility clause of the quality agreement should be drafted.

4. Practical recommendations

• Separate the three parties on paper first — product owner, legal manufacturer, contract manufacturer — and map them to fields h and f and to the contract under Chapter 6, item 11.
• Choose between the manufacturing contract and the quality agreement, but obtain SAJ approval either way and file a copy.
• Plan a change of contract manufacturer as a new registration, not as a post-registration change (Chapter 9, item 18 b).
• For multi-site manufacturing, register each plant separately under Annex C, C.1 e, and note that a change of contract party also affects family grouping.
• Where commercial terms cannot be disclosed, use a quality agreement in place of the manufacturing contract, with SAJ approval obtained in the same way.
• Draft the responsibility clause of the quality agreement on the basis of Chapter 5, Article 7: responsibility stays with the legal representative of the legal manufacturer.

5. Verification checklist

• □ Product owner, legal manufacturer and contract manufacturer have been separated and mapped to the application fields
• □ A manufacturing contract or quality agreement has been selected and approved by SAJ
• □ A change of contract manufacturer has been planned as a re-registration under Chapter 9, item 18 b
• □ Multi-site manufacturing has been registered plant by plant under Annex C, C.1 e
• □ Where a quality agreement replaces the contract, SAJ approval has been confirmed as still required
• □ The responsibility clause of the quality agreement states the allocation required by Chapter 5, Article 7

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