The Good Manufacturing Practices (GMP) Certificate is the legal document that certifies that the company manufactures its products under conditions and practices based on a series of norms and/or standards that ensure the quality, efficacy, and safety of Medical Devices; and that they meet the necessary requirements in compliance with the applicable regulations to produce products with the three indispensable characteristics mentioned above.
Essential characteristics of the GMP Certificate
For a GMP Certificate to be valid in Mexico, it must meet the following characteristics:
- Scope of the Certificate: The document must certify the manufacturing line(s) of the product(s) to be registered. It is crucial that the scope of the certificate is clearly defined and matches the products intended to be marketed in Mexico.
- Validity of the Certificate: The certificate must be valid at the time of the Registration submission. If the document does not contain an explicit expiration date, the inspection date for issuing the certificate must not exceed 30 months.
- Authentication of the Certificate: To guarantee the validity of the certificate, it must be authenticated according to the following procedures:
- Legalization: For countries not part of the Hague Convention, the certificate must be legalized by the Mexican consul in the country of origin.
- Apostille: For member countries of the Hague Convention, the certificate must be apostilled. The Apostille must be issued only by a competent authority designated by the State of origin of the document.
Note: In the case of ISO 13485 or MDSAP certificates, the Apostille can be issued in the manufacturer’s country or the country of the certifying body.
- Language of the Certificate: It can be submitted in Spanish or English. If the document is in another language, a translation by an authorized expert translator in Mexico will be required.
- Presentation of the Certificate: The certificate can be submitted in its original format or as a notarized copy in Mexico.
Equivalent Documents
- ISO 13485 Certificate – Issued by an authorized body.
- MDSAP Certificate – Issued by an authorized body to certify this type of audits.
- CE Mark Certificate for medical devices – Issued by an authorized body in the European Union.
- Declaration of compliance with Good Manufacturing Practices included in the Free Sale Certificate (FSC) – The FSC must be issued by the Ministry of Health of the issuing country or, where applicable, by the relevant Ministry that regulates the product.
Harmonization with international standards
The characteristics of the GMP Certificate for medical devices in Mexico are aligned with international standards established by organizations such as the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO). This regulatory harmonization facilitates the international trade of medical devices and ensures public health protection globally.
Source:
Pharmacopoeia of the United Mexican States Supplement of Medical Devices 5.0, 2023
