MDSAP Recognition in Mexico
The Medical Device Single Audit Programme (MDSAP) is an international QMS audit programme that allows a single regulatory audit of a manufacturer's quality system to satisfy the GMP audit requirements of multiple regulatory authorities simultaneously.
MDSAP participating authorities
| Authority | Jurisdiction |
|---|---|
| FDA | USA |
| Health Canada | Canada |
| ANVISA | Brazil |
| TGA | Australia |
| PMDA | Japan |
How COFEPRIS recognises MDSAP
COFEPRIS formally recognises MDSAP audit certificates in two ways:
1. GMP evidence in registration dossiers
An MDSAP audit certificate is accepted by COFEPRIS as evidence of NOM-241 GMP compliance in standard route registration applications. This means manufacturers with MDSAP certification do not need a separate NOM-241-specific GMP assessment.
2. Equivalency Route qualification
The June 2025 Acuerdo extended the Equivalency Route to include all MDSAP-participating authority approvals, meaning devices approved through FDA, Health Canada, TGA, PMDA, or ANVISA can qualify for the abbreviated 30-working-day pathway.
Benefits for MDSAP-certified manufacturers
- Single audit satisfies GMP requirements for Mexico and multiple other markets.
- MDSAP certification strengthens the equivalency route application.
- Reduces audit burden for manufacturers selling across multiple MDSAP markets.
MDSAP vs ISO 13485
Both MDSAP certification and ISO 13485 certification are accepted by COFEPRIS. MDSAP provides broader multi-market recognition, while ISO 13485 is the global baseline. Manufacturers with MDSAP certification have the advantage of regulatory recognition from five jurisdictions simultaneously.
Auditing bodies
MDSAP audits are conducted by MDSAP-recognised Auditing Organisations (AOs) accredited to conduct MDSAP audits. A list of recognised AOs is maintained on the IMDRF website.