Last August 13th 2021, COFEPRIS announced a new version of the so called ECAR program. This is basically an initiative from the authority to minimize the backlogged Medical Device applications. The main drawback is that the deadline to apply for it was August 20th 2021. Even though this alternative has expired, it is expected to be offered again. In this article, we will discuss details about the program and how it will benefit Medical Device manufacturers from all over the world.
Before describing the ECAR program, it is worth mentioning that COFEPRIS has announced in the last year, three amendments intended to expedite or reduce the regulatory requirements in Mexico:
- Faster responses for the Equivalency Agreements.
- English Translations not required and a new scheme for renewals.
- Extended Equivalency Agreements.
All these steps has been consistent with the COFEPRIS authorities’ mission to provide faster responses without compromising the safety, quality and efficacy of the medical devices. We invite you to check more details about these amendments that could ease the process to get into the Mexican market.
Regarding ECAR, the authorities communicated that this program will be eligible for those Medical Device Holders, with submissions that have exceeded the legal timeframes. To provide a better idea of this program, we present a summary of the key facts:
- Limited to a certain number of submissions per week during a 4 week period (Deadlines to submit: August 20th and 27th – September 3rd and 10th).
- The Holder must resubmit the electronic version of the dossier.
- The authority expects to give a response in a period of 30 days after the submission deadline. During this period, there will be a close communication between the reviewers inside COFEPRIS and the Holders.
There are still questions about this process, but it is expected that all the gaps will be closed during the execution of the program.
In conclusion, ECAR is another action from COFEPRIS to expedite responses. This is not an isolated strategy but the result of others, giving us a clearer picture that the local authorities are striving to comply with the legal timelines –a hot topic that has chased this commission for years.
We will keep you updated about this and other important amendments. If you have any question or comment, feel free to contact us at email@example.com or visit our guidelines.