Free Sale Certificate and GMP Certificate: Article 6.3.2.1 c) and d)

1. Key takeaways

Article 6.3.2.1 c) and d) of RTS 11.03.02:21 make the free sale certificate (Certificado de Venta Libre, CVL) and the GMP certificate general requirements for every device registration, and neither item carries a where applicable qualifier. The contrast sits inside the same article: item f), the manufacturing or maquila contract, is expressly limited by the phrase cuando aplique, while items c) and d) are not. In practice the two certificates are unconditional components of the dossier, and the only open question is what evidence may stand in their place.

Article 3.9 defines the GMP certificate as a document issued by the competent authority of the country in which the manufacturing, import, export, distribution or storage establishment is located, certifying that the establishment complies with good manufacturing practice. The closing paragraph of article 6.3.2.1 requires every official or legal document issued abroad to be legalised under national rules, a condition that in practice falls on exactly these two certificates, because both are normally issued outside El Salvador.

• CVL and GMP certificate are unconditional items, with no where applicable escape clause.
• The GMP certificate must come from the authority of the country where the site is located.
• Both documents are normally issued abroad, so both attract the legalisation requirement.
• Dossier documents must remain valid throughout the procedure, under article 6.3.1 e).
• Equivalent evidence is available through the reliance policy rather than through omission.
• Spanish labelling is a separate obligation from legalisation, not a substitute for it.

2. Legal basis

The two certificates are anchored in the general dossier article, defined in the terminology article and qualified by the reliance policy issued by the same regulator. The table records the provisions that govern what must be filed, who may issue it, and what alternative evidence the regulator is prepared to recognise.

3. Expert insights

First insight: neither CVL nor GMP certificate has a where applicable exit. Inside article 6.3.2.1, item f) is written with cuando aplique, while items c) and d) are not. The consequence is that even a product already marketed in the European Union or the United States, and even a manufacturer already audited under MDSAP, must still file these two documents in form. The flexibility offered by the regulation concerns what may serve as equivalent evidence, not whether the item may be left out of the index. Applicants who read the absence of a waiver as an oversight usually discover the opposite during acceptance review.

Second insight: where a Chinese manufacturer cannot obtain a CVL or GMP certificate in the national format, the reliance policy is the entry point to a solution. Article 3.9 requires the GMP certificate to be issued by the competent authority of the country where the site is located. If the Chinese authority does not issue a certificate in that format, section 6.8 of the reliance policy, in its URDM segment, becomes relevant: ISO 13485 certificates issued by accredited bodies, MDSAP certificates and EU 2017/745 and 2017/746 conformity certificates are all accepted as equivalent evidence of GMP, and CVLs and marketing authorisations issued by foreign regulators appear on the same recognition list.

Third insight: verifiability of equivalent evidence is a hard condition, not a courtesy. Section 6.2 of the reliance policy lists the availability of verifiable documents in a publicly accessible web space as one of the eight criteria applied to a reference authority. Section 6.6 then requires that every document be verifiable or duly legalised, and that the status of the reference authority approval be checked for revocation, suspension or modification. Filing an ISO 13485 certificate therefore means filing the accreditation details of the issuing body alongside it, so that the regulator can perform the check without correspondence.

Fourth insight: legalisation and Spanish are two independent operations. The closing paragraph of article 6.3.2.1 speaks only of legalisation under national rules and says nothing about translation, while article 6.3.4 d) requires the primary packaging label to be in Spanish or to use symbols from the current edition of ISO 15223-1. The two operations point at different things: legalisation confirms the legal force of a document, Spanish confirms the readability of labels and instructions for use. Completing legalisation is therefore never a reason to postpone the Spanish version, and the Spanish version never removes the need for legalisation.

The two certificates also age at different speeds. A CVL is usually issued against a specific product and a specific period, while a GMP or ISO 13485 certificate runs against a site and an audit cycle, so a product-level certificate can lapse while the site certificate remains in force. Tracking both on one register, with the issuing body and the scope of each document recorded beside the expiry date, is what allows a renewal to be planned rather than discovered.

4. Practical recommendations

• Treat CVL and GMP certificate as unconditional items and do not build a filing strategy around a where applicable exemption that the text does not contain.
• Where a Chinese manufacturer has no CVL or GMP certificate in the national format, invoke section 6.8 of the reliance policy and substitute ISO 13485, MDSAP or EU certificates.
• Attach the accreditation details of the issuing body whenever an equivalent certificate is filed, so that verifiability can be confirmed without follow-up correspondence.
• Check that the reference authority approval has not been revoked, suspended or modified before relying on it.
• Run legalisation of foreign documents and preparation of the Spanish version in parallel, as two separate workstreams.
• Enter the expiry dates of the CVL and the GMP certificate into the dossier register, so that validity is maintained under article 6.3.1 e).

5. Verification checklist

• □ CVL obtained, or replaced by equivalent evidence recognised under the reliance policy
• □ GMP certificate obtained, or replaced by an ISO 13485, MDSAP or EU certificate
• □ Accreditation details of the issuing body attached to equivalent certificates
• □ Status of the reference authority approval verified
• □ Foreign documents legalised
• □ Spanish version prepared in parallel

The regulations cited in this article are RTS 11.03.02:21, Dispositivos Médicos. Requisitos para la Regulación Sanitaria de Dispositivos Médicos (Acuerdo No. 14-2022, Diario Oficial No. 156, Tomo No. 436, 2022-08-23), articles 3.9, 6.3.1 e), 6.3.2.1 c), d) and closing paragraph, and 6.3.4 d); and the Política de Aplicación de Reliance (01.01.02.POL.20250508.01, Versión No. 01, SRS website, 2025-05-08), sections 6.2, 6.6 and 6.8.

Regulatory information verified as at 29 October 2026.

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