Medical Device Regulatory Requirements in Mexico
| Regulatory Authority |
COFEPRIS (Federal Commission for the Protection against Sanitary Risk) |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I,II,III |
| Medical Device Regulations |
Mexican Technical Regulation NOM-241-SSA1-2021
| Click Here
|
| IVD Classification |
A,B,C,D |
| Registration Timeline |
4 to 6 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Spanish Language |
| Additional Information |
Prior to entering the Mexican market, foreign manufacturers must designate a Mexican Registration Holder (MRH). |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025