Last March the 6th, COFEPRIS updated its Good Manufacturing Practices (GMP) guide. This guide describes the criteria to evaluate the good manufacturing practices certificates or equivalent documents submitted when requesting, modifying or extending a medical device sanitary registration.
In this review, we highlight the most important points included in this guideline.
GMP’s accepted by COFEPRIS
COFEPRIS accepts GMP certificates issued by:
- A recognized authority (FDA, HC, MHLW, EMA, TGA, MFDS, MHPRA and Swissmedic).
- The Health Authority in the country where the product is manufactured.
- You can get a GMP issued by COFEPRIS requesting a verification inspection by this authority. This option is useful when you do not have a valid GMP issued by any authority.
- The verification inspections are not eligible for devices that are considered low risk or not considered medical devices as well.
- Only one medical device line per request is valid for verification inspections for foreign manufacturers.
Validity of the GMP Certificate
Any GMP submitted to COFEPRIS must meet the following conditions:
- Present the original document or notarized copy of the whole document, keeping the original in case COFEPRIS requests it for confirmation.
- All GMPs must be legalized or apostilled in the same country where the authority issued the GMP certificate.
- GMPs not issued physically or issued with electronic signature does not require to get apostille or being legalized. They might be verified on official sites when applicable.
- The document must be valid upon submission to COFEPRIS.
- The GMP certificate must remain valid for the duration of the sanitary registration.
GMP certificates must include:
- Company name of the legal manufacturer.
- Addresses of all manufacturing sites involved in the production of the medical device.
- Expiration date. If not indicated, it is considered valid 30 months from the date of issuance.
- Lines of production, products, medical devices or processes that are certified in the GMP.
Documents considered equivalent to a GMP certificate
- ISO 13485 certificate (current version) issued by a certified organization.
- CE mark certificate issued by an authorized organism in the European Union.
- Declaration of compliance with the GMP included in the Free Sale Certificate issued by the Ministry of Health in the country of origin.
Documents that are not considered equivalent to a GMP certificate
- Certificate of Conformance.
- Establishment Inspection Report (EIR) when a sanitary registration is requested through the standard process
Documents considered as equivalent to the EIR for FDA Equivalency Agreement submissions
- For FDA approved class I medical devices: Last inspection report issued by an MDSAP member.
- For FDA approved class II medical devices with 510(k): ISO 13485 certificate (current version) issued by a MDSAP member.
- For FDA approved class II and III medical devices with PMA (Pre-Market Approval), there is no equivalent document and EIR must be presented.
Documents considered as equivalent to the GMP for Health Canada (HC) Equivalency Agreement route
The following documents can be submitted to meet the COFEPRIS requirements:
- ISO 13485 certificate (current version) issued by a MDSAP member.
- ISO 17021 certificate issued by the same MDSAP member that issued the ISO 13485.
- The organism (Registrar) issuing both certificates must be listed as a MDSAP member.
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