Seven Mandatory Items of the Third-Party Manufacturing Contract

1. Key takeaways

Article 11.8 of the main regulation requires that, in third-party manufacturing arrangements (fabricación por terceros), the manufacturing contract or the relevant extract concerning the parties to the contract be submitted, in the form of the original or a certified copy of a legalised or apostilled document, and that it contain at least seven items: signature by both parties (11.8.1); the commitment to comply with BPM (11.8.2); production and analytical conditions or other relevant technical management (11.8.3); handling of raw materials, finished products and non-conforming product (11.8.4); permission for the contracting party to enter the contracted party’s premises for audits (11.8.5); the list of products or analytical services covered by the contract (11.8.6); and the complete information of both parties together with the contract’s validity period and product type (11.8.7).

• An extract of the contract is acceptable, provided all seven mandatory items are contained in it.
• Signature form is differentiated: Costa Rican entities must sign with the legal representative’s digital signature.
• Foreign signatures follow the legalisation or apostille route of Article 10.17.
• The audit right of the contracting party is a mandatory clause, not an optional extra.
• The contract’s validity period links to renewal under Article 16.3: an expired contract must be replaced with a current one at renewal.

2. Legal basis

The seven-item list sits in Article 11.8 and its sub-items, and it is linked to renewal and change filings by the provisions listed below.

3. Expert insights

Insight 1. Article 11.8 accepts a relevant extract of the contract (extracto relativo a las partes del contrato de fabricación), which is a pragmatic burden-reducing design. Many manufacturing contracts contain confidential commercial clauses on pricing and exclusivity, and submitting the full text is unrealistic. The regulation allows only the parts concerning the contracting parties to be submitted, provided the seven mandatory items are all contained in the extract. Companies should therefore compile a dedicated compliance extract that presents the seven items together, rather than simply copying the first pages of the contract.

Insight 2. Article 11.8.1 differentiates the signature form for domestic and foreign entities. The text provides that the contract is signed by the holder and the manufacturer jointly or separately, and that where the holder and/or the manufacturer is a Costa Rican entity, the document must be submitted with the digital signatures of the legal representatives of both parties. This means that where a domestic entity participates, the signature form escalates to a digital signature, connecting with the central bank standards referenced in Article 10.2. Signatures by foreign entities follow the legalisation or apostille route of Article 10.17.

Insight 3. Article 11.8.5 writes the audit right into the contract as a mandatory clause, and it is the core of the allocation of quality system responsibility. The provision requires the contract expressly to allow the contracting party (contratante) to enter the contracted party’s (contratista) premises to conduct audits. The meaning is that under the Costa Rican regulatory view, the holder cannot outsource quality responsibility entirely — the contract must preserve the holder’s on-site audit right. Without this clause, traceability of the quality system is surrendered at the contract level.

Insight 4. The contract’s validity period is a mandatory item under Article 11.8.7 and is linked to the renewal provisions. Article 11.8.7 requires the validity period to be stated; Article 16.3 provides that at renewal, if the contract in the dossier has expired, a currently valid contract must be submitted. This linkage means the expiry date should be monitored in the registration ledger, and the contract should be renewed before or in step with the renewal window; otherwise a documentation deficiency will arise at renewal.

4. Practical recommendations

• Compile a dedicated contract compliance extract organised around the seven-item list, avoiding submission of the full text containing trade secrets.
• Where a Costa Rican entity participates, use the legal representative’s digital signature (11.8.1); foreign entities process legalisation or apostille under Article 10.17.
• Write the contracting party’s on-site audit right expressly into the contract (11.8.5); do not omit it.
• State the validity period and the type of products covered (11.8.7), and monitor the expiry date in the registration ledger.
• Before renewal, check under Article 16.3 that the contract is still valid; where it has expired, renew it first and then file for renewal.

5. Verification checklist

• □ Contract or compliance extract submitted (11.8)
• □ Signed by both parties with the required digital signature (11.8.1)
• □ BPM compliance commitment included (11.8.2)
• □ Production and analytical conditions specified (11.8.3)
• □ Materials and non-conforming product handling described (11.8.4)
• □ Contracting party’s audit right included (11.8.5)
• □ Covered products or services listed (11.8.6)
• □ Parties’ information, validity period and product type stated (11.8.7)

Related reading: [BPM certificate and the deferral effect of Transitorio I](/costa-rica-medical-device-registration/bpm-certificate-and-transitorio-i-deferral/) | [Five-year validity and the eleven renewal items](/costa-rica-medical-device-registration/five-year-validity-and-renewal-eleven-items/) | [Nineteen categories of post-registration changes and four notification items](/costa-rica-medical-device-registration/post-registration-changes-nineteen-categories/)

Regulatory information verified as of October 29, 2026.

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