A third party reviewer (TPR) is a company authorized by COFEPRIS to review and issue an opinion regarding the compliance of a medical device to obtain the Sanitary Registration in Mexico.
In other words, a TPR is an organization that meets all the legal requirements to help COFEPRIS by performing a previous review of a Sanitary Registration request and speeding up the approval process.
TPRs are only able to review Sanitary Registration requests made by the ordinary process, so equivalency agreement requests are not eligible to undergo TPR previous review.
The TPR concludes with the issuance of a legal document called Technical Report which certifies that all requirements are meet according with the Mexican Rules. Furthermore, COFEPRIS will double check the information submitted in the request based on the Technical Report. Ultimately, COFEPRIS is the authority that will grant the Sanitary Registration.
The advantages and drawbacks of submitting a Sanitary Registration request with the intervention of a TPR are listed below:
- Optimized approval times
- Reduced uncertainty regarding the requirements to be evaluated by COFEPRIS
- Wrong information detection
- TPR feedback and support after the COFEPRIS submission and review
- Additional costs
- Equivalence routes are not eligible for the TPR route
- Approval times are subject to COFEPRIS availability
- A TPR cannot guarantee that a Sanitary Registry will be granted by COFEPRIS
A TPR can be a great support for a successful medical device approval in Mexico. Just consider all the points mentioned above to get the right one. There are eighteen options to choose from the following list:
- CORPORACIÓN VERIFICADORA DE SISTEMAS Y SERVICIOS, S.C. (COVSS)
- ASOCIACIÓN DE NORMALIZACIÓN Y CERTIFICACIÓN, A. C.
- UNIDAD CERTIFICADA DE VERIFICACIONES SANITARIAS UNIVERIX S.A.P.I. DE C.V.
- NORMALIZACIÓN Y CERTIFICACIÓN NYCE, S.C.
- DEFILATINA HEALTHCARE, S.A. de C.V.
- TERCEROS AUTORIZADOS EN PROTECCIÓN Y VERIFICACIÓN SANITARIA, S.A.P.I. DE C.V.
- DT DISPOMEDIC, S.A. DE C.V.
- ENTIMEM, S.A. DE C.V.
- UVEDIM, S.A. DE C.V.
- TERVSAN, S.A.P.I. DE C.V.
- FACTUAL SERVICES, S.C.
- OPCIÓN TA S.A. DE C.V.
- TERCERO AUTORIZADO EN EVALUACIÓN TÉCNICA SANITARIA, S.C.
- AM DYNAMIC SERVICE, S.A. DE C.V.
- TERCEROS AUTORIZADOS CERTIFICADOS MEXTA, S.A. DE C.V.
- TERCEROS EN SERVICIOS DE RIESGOS SANITARIOS S.A.P.I.DE C.V.
- UNIDAD DE APOYO AL PREDICTAMEN, S.A. DE C.V.
- TERCERO EN MEDICAMENTOS Y DISPOSITIVOS, S.A DE C.V.
For more information, check similar notes in our Guides.
Note: Last update 11 December 2020. If you find any problem on this list or any other topic, please write us to email@example.com.