Manufacturer Authorisation Letter (Carta de Representacion del Fabricante)

1. Key takeaways

The manufacturer authorisation letter (Carta de representacion del fabricante) is a statutory document required by item II of Article 180 of the RIS, and its trigger condition is that the product is not manufactured by the parent company, plant or laboratory applying for registration. The 2025 low-risk protocol confirms this requirement again for imported products: where the applicant is not the manufacturing parent company, the letter must be submitted. The letter must state the scope of the authorisation, the scope of products covered and its validity period, and it must go through Spanish translation and the corresponding legalisation formalities. Because the letter is issued by the manufacturer and consumed by the Mexican application, coordination between the two sides should begin during dossier preparation rather than at the moment of filing.

• The letter is triggered by the manufacturing entity relationship, not by the country of manufacture.
• The letter and the registration holder arrangement are two separate documents and cannot substitute for each other.
• Three elements are indispensable: scope of authorisation, scope of products, and validity period.
• Non-Spanish letters require certified translation into Spanish and notarisation and legalisation.

2. Legal basis

Two instruments establish the obligation. Item II of Article 180 of the RIS, introduced through the amendment order published in the Diario Oficial de la Federacion on 24 April 2026, requires the manufacturer authorisation letter where the product is not manufactured by the parent company, plant or laboratory applying for registration. The 2025 low-risk protocol, published in the Diario Oficial de la Federacion on 15 July 2025, restates the requirement for imported products in Annex 1. Article 153 of the RIS governs the official application form and the annexing of the documents listed in the regulation. The table below consolidates these sources.

3. Expert insights

Insight 1: the trigger is the manufacturing entity, not the country. The provision looks at whether the product is manufactured by the parent company, plant or laboratory applying for registration; where the product is manufactured is a separate layer of assessment. Manufacturing that takes place across legal entities within a corporate group triggers the letter just as outsourced manufacturing does. Applicants should map the manufacturing entity relationship first and let that analysis, not intuition about geography, decide whether the letter is required for a given filing.

Insight 2: the authorisation letter and the registration holder arrangement are two documents. The authorisation letter answers the question of whom the manufacturer permits to apply for the registration, while the holder arrangement answers the question of who is recorded as the holder of the registration once granted. Foreign manufacturers usually need both layers in place, and neither can replace the other. Confusing the two documents is a recurring source of filing errors, so keeping them clearly distinguished in the dossier plan avoids rework later in the process.

Insight 3: all three elements of the letter are indispensable. The scope of authorisation states what the applicant may do, the scope of products states which models are covered, and the validity period states until when the authorisation runs. A letter missing any one of the three elements may be classified as an administrative correction item. Reviewing the draft letter against this three-element list before signature, and having the manufacturer confirm each element in writing, is a small investment that prevents the letter from becoming the weak link in an otherwise complete dossier.

Insight 4: lapses tend to occur at renewal and amendment milestones. When a letter expires and is not refreshed, the gap is often discovered at the moment a renewal (Prorroga) or amendment (Modificacion) is filed, which interrupts the process. Managing the validity period of the letter in alignment with the validity period of the registration reduces this class of problem. Treating the letter as a living document with its own expiry date, tracked alongside the registration itself, keeps it from silently lapsing between filings.

Insight 5: language and legalisation are hard requirements. An authorisation letter that is not in Spanish must go through certified translation. A letter issued in Chinese requires a Spanish-language version, and the notarisation and legalisation formalities must be completed according to the applicable process. These formalities have their own lead times, and they should be scheduled in parallel with the drafting and signature of the letter itself rather than queued behind it, so that the certified and legalised original is ready when the dossier is assembled.

4. Practical recommendations

• During dossier preparation, first determine the manufacturing entity relationship and whether an authorisation letter is required.
• State the scope of authorisation, the product list and the validity period in the letter; as a practical estimate, the validity period should not be shorter than the registration period plus a renewal buffer.
• Maintain an expiry ledger for authorisation letters, with reminders linked to the registration, renewal and amendment milestones.
• Complete certified Spanish translation and notarisation and legalisation, and archive the original and the translation together.
• Where a group supplies the product from multiple plants, issue a separate authorisation letter for each manufacturing entity.

5. Verification checklist

• □ The manufacturing entity relationship has been assessed and the need for an authorisation letter determined.
• □ The scope of authorisation is clearly stated.
• □ The product scope matches the declared list.
• □ The validity period covers the registration period and the renewal buffer.
• □ Certified Spanish translation and notarisation and legalisation have been completed.
• □ Separate letters have been issued for each supplying plant where multiple plants are involved.

Legal information verified as of 28 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Mexican market. Our team manages COFEPRIS registrations and equivalence (equivalencia) reviews, coordinates third-party authorised centre routes, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com