Certificate of Free Sale (CFS) and Certificate to Foreign Government (CFG)

1. Key takeaways

Mexico accepts two documents in parallel as the certificate of free sale or equivalent document required by item I of Article 180 of the RIS: the Certificado de Libre Venta (CFS) and the Certificate to Foreign Government (CFG). The issuing body must be the health authority of the country of origin or of the reference country; a certificate issued by an industry organisation or by the company itself does not satisfy the requirement. Getting this document right is one of the earliest, highest-leverage steps in a Mexican submission, because the CFS anchors the foreign-manufacture annex of the dossier, its issuing authority and product scope are checked against the registration application, and its issuing lead time is typically longer than that of most other dossier documents.

• Either a CFS or a CFG is acceptable, as the certificate of free sale or equivalent document under item I of Article 180.
• The issuer must be the health authority of the country of origin or of the reference country.
• The product scope on the certificate must match the scope declared in the registration application.
• For the simplified pathway, the reference approval must additionally have been obtained within 5 years.

2. Legal basis

Three sources define the requirement. Item I of Article 180 of the RIS, introduced by the amendment order published in the Diario Oficial de la Federacion on 24 April 2026, requires a certificate of free sale or equivalent document issued by the health authority of the country of origin. The guidelines for the simplified pathway, published in the Diario Oficial de la Federacion on 18 July 2025, add a separate condition: the reference approval must have been obtained within 5 years. Article 153 of the RIS governs the official application form and the requirement to annex the documents listed in the regulation. The table below consolidates these sources.

3. Expert insights

Insight 1: the difference between the CFS and the CFG lies in the issuing perspective. The CFS certifies that the product may be freely sold on the market of the country of origin, while the CFG is a certificate that the competent authority of the country of origin issues for export purposes. The Mexican provision covers both instruments through the phrase or equivalent document. In practice, the choice is made according to the type of document the country of origin is able to issue, and applicants should confirm with their own authority which of the two is available for their product category before committing to either route.

Insight 2: the issuing route for Chinese companies is well defined. Companies within China may apply for the certificate of export sale through the channel of the drug regulatory authority. Once obtained, the certificate must go through certified translation into Spanish and the corresponding notarisation and legalisation formalities. This is the customary chain through which Chinese-language documents enter a Mexican dossier, and treating it as a standard workstream with its own lead time, rather than as an afterthought at the end of dossier assembly, keeps the filing date secure.

Insight 3: the 5-year requirement is not the same thing as the validity of the CFS. Article 180 requires that the CFS itself be within its validity period; the guidelines for the simplified pathway separately require that the reference approval was obtained no more than 5 years ago. These are two distinct time points attached to two distinct documents, and each must be checked on its own terms. A valid CFS paired with an aged reference approval does not satisfy the simplified pathway, and a recent approval paired with an expired CFS does not satisfy Article 180.

Insight 4: the product scope on the CFS must match the declared scope. The product names, models and manufacturer information listed on the certificate must be consistent with the registration application. A mismatch in scope is treated as an administrative correction item. Aligning the certificate application with the Mexican declared list before the certificate is issued, rather than requesting a reissue afterwards, is the efficient way to avoid this category of deficiency, since reissuing through the foreign authority can consume weeks.

Insight 5: where several national CFS documents coexist, submit the one that matches best. Companies that sell into multiple markets hold several certificates of free sale at the same time. The one submitted to Mexico should be the certificate whose product scope most closely matches the version declared in the Mexican application and which is still within its validity period. Reviewing the portfolio of available certificates against the declared scope at the start of the project, rather than defaulting to the most recently issued one, produces the cleanest possible match.

4. Practical recommendations

• Start the CFS or CFG application in the first month of dossier preparation, because its issuing lead time is often longer than that of the other documents.
• Tailor the product scope on the certificate to the list declared in Mexico, avoiding a scope that is either too broad or too narrow.
• Maintain an expiry ledger for CFS documents and refresh them ahead of each milestone for registration, renewal and amendment.
• Arrange certified Spanish translation for certificates issued in Chinese, and complete the notarisation and legalisation formalities as required.
• For the simplified pathway, separately verify that the reference approval was obtained within 5 years.

5. Verification checklist

• □ The CFS or CFG was issued by the health authority of the country of origin or of the reference country.
• □ The certificate is within its validity period.
• □ The product scope on the certificate matches the declared scope.
• □ Certified Spanish translation and notarisation and legalisation have been completed.
• □ For the simplified pathway, the 5-year limit on the reference approval has been checked separately.
• □ An expiry ledger for CFS documents has been established.

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