The Free Sale Certificate (FSC) or Certificado de Libre Venta (CLV) in Spanish, is a document through which the Health Authority of the country of origin, whether the real or legal manufacturer of the medical device to be registered, certifies that the product is authorized and complies with the legal provisions of the country and that it can be sold, used or consumed freely and without any restrictions in the country.
This document is a mandatory requirement for the registration of foreign-made Medical Devices in Mexico.
Main features:
- It must be issued by the Ministry of Health of the country of origin of the product.
- The document must be current at the time of its presentation. If the document does not contain the expiration or validity date, the document issuance date must not be more than 30 months.
- The document must be authenticated, this means that it must be:
- Legalized or endorsed (by a Mexican consul in the country of origin, after notarization) for countries that do not belong to the Hague convention. Or that their agreement with the Hague convention does not allow them to apostille FSCs.
- Notarized and Apostilled for countries that belong to the Hague convention. The Apostille must be issued by the competent authority in each country. (more information at: https://www.hcch.net/es/instruments/conventions/specialized-sections/apostille )
- It is very important that the legalization or apostille is carried out in the same country in which the document is issued.
- The document can be presented in Spanish or English, if it is in a different language, translation into Spanish will be required by an expert translator in Mexico, before its presentation to the authority.
- The document can be submitted in original or in a copy certified by a notary in Mexico.
What should it include?
- Product name (Distinctive name and model)
- Legal Manufacturer Data (Company name and address)
- Data on the actual manufacturer or manufacturing site, if applicable (company name and address)
- List of presentation codes
- It must indicate that the product has been authorized in the country of origin of the product for sale and consumption.
Equivalent documents:
1. Letter issued by the Ministry of Health of the country of origin indicating that said products are not subject to health control.
2. Document issued by the corresponding government Ministry, which regulates medical devices in the country of origin, of which evidence must also be presented.
3. If the product does not have a FSC, then reports of clinical studies carried out in Mexico must be submitted, in accordance with applicable Mexican regulations.
Source:
Pharmacopeia of the Mexican United States Medical Device Supplement 5.0, 2023
