Mexico
COFEPRIS Registration
What is medical device in Mexico?
Medical Device Definition
Medical devices are instruments, devices or materials used to prevent, diagnose or treat diseases and improve the quality of life of the population.
Classification of Medical Device
There are four classifications for medical device in Mexico.
- Class I Low : Low risk
- Class I : Low to medium risk
- Class II : Medium risk
- Class III : High risk
What is COFEPRIS?
COFEPRIS is Regulatory authority in Mexico who is,
Regulating the Medical Device to ensure its safety and efficiency before reaching patients.
Local Representative (MRH)
Mexico registration holder is required to proceed the Medical device registration.
1) MRH shall qualified and keep license to submit the medical device application to COFEPRIS.
Local Represenataive (MRH)
For medical device registration, Foreign manufacture shall appoint the License holder in Mexico to proceed the application.
- MRH shall keep valid license for the medical device application.
- MRH can control the Device license but they don’t need to be the part of importation procedure.
- Multiple importer can be included in the existing license.
Procedure
For COFEPRIS registration, usually country of origin is required and some documents shall be translated in Spanish.
Due to the long review period(approx 8~10 months), it is important to prepare dossier package precisely to avoid the delay due to the Additional information request from COFEPRIS.
What else?
License can be transferred from one to another but not recommended as MRH can control the license.
Validity of the license is 5 years and renewal procedure is required. Please be sure license amendment is possible but also need long lead time.
Mostly, there is not much lead time difference with Class I and Class II device.
HC, FDA, MHLW and partially MFDS registration can be a reference.