Mexico is the 4th largest user of Medical Device technology in the Americas. If it is a strategic target market for you, be careful; all medical devices must follow labeling requirement found in NOM-137-SSA1-2008! Labeling and instructions for use must be submitted in Spanish.
Here is a list of the required translations or documents that should be presented in Spanish to the Mexican authorities.
Registering a Medical Device
To be imported into Mexico, all medical devices must be registered through the Sanitary Registration process with the Mexican Secretariat of Health. The following documents are required in Spanish:
- A copy of the label with information as required by Official Mexican Norms
- Instructions for the device’s use or operation manual.
For imported products COFEPRIS requires these documents translated into Spanish:
- Certificate of Free Sale (or Certificate for Foreign Government) issued by the authority of the country of origin. In the case of U.S.-made devices, these certificates are issued by the Food and Drug Administration (FDA), and assures the authorities of the importing country that the product complies with U.S. law.
- Certificate of Good Manufacturing Practice in force issued by the health authority country of origin or equivalent document issued by the body authorized by the country of origin.
- Original or certified copy of the original letter of representation issued by the manufacturer, if the product is not manufactured by the parent company, subsidiary or affiliate of the registrant in Mexico, authenticated that the legal procedure that exists in the country of origin.
The Mexican Official Standard on labeling of medical devices, NOM-137-SSA1-2008 (Labeling Standard) was published in the Mexican Official Gazette on December 12, 2008. This standard specifies the information that must be contained on labels of domestic and foreign manufactured medical devices offered to Mexican consumers. Check out the Labeling Standard online.
According to the Labeling Standard, the label must be in Spanish, and may include another language. When information on the label is in a language other than Spanish, it may be up to the same size and typeface proportionality, and not contradict the Spanish-language text. The minimum information required should include, but not limited to, the following:
- Generic and trade product names. Domestically-manufactured products must be indicated as such.
- Imported products must state the country where the device was made or manufactured, as well as the corporate name and address of the importer or distributor in Mexico.
- Country of origin, Registration Number issued by the Ministry of Health, Product expiration date as appropriate, lot number or serial number and Contents.
- Instructions for use.
- Warnings of incidents that may result from use of the product, if applicable and Warning legends as appropriate.
- When the medical device requires specific software for its operation, this program must declare the appropriate version.
Additional documents must be presented in Spanish in order for the imported product to be released from Mexican Customs such as Import Declaration, called the pedimento de importación, commercial invoice (in Spanish), bill of lading or airway bill, sanitary import notice, NAFTA certificate of origin and certificate of Free Sale or Certificate to Foreign Government.
How to Translate Medical Devices for Mexico
If you already have a Spanish version of your product, you do not need to re-translate medical documentation, leaflets and labels. All you need to perform is a throughout review. For help in translating your medical device documents into Spanish, or for implementing a throughout review for Mexico, or for more info on how GlobalVision offers the highest quality Medical Device Translations, please request our complementary white paper 5 Case Studies in Medical Translation & Localization, or register to the free Healthcare Product Localization Webinar.