Traditionally our MoH does not comply with the official times of registration, based on our experience (pre-COVID), we can give you an estimate from submission, of a 100% completed dossier, in Spanish, just as Cofepris expects it.
Traditional path of registration directly to Cofepris (pre-COVID timing):
- New registration: Class IA: 1-3 months.
- New registration: Class I and II: 6-10 months
- New registration: Class III: 10-18 months
If the dossier is not complete, or if there is a doubt about anything, Cofepris will request additional information in a deficiency letter, called “prevention”. Cofepris provides a deathline to answer that prevention, if the information is not submitted complete and on time, the application will be cancelled, so always consider that the more complete the dossier is, the faster it will be approved, as the issuing of a prevention delays the registration time in about 4 months, plus the time you take to get the information and answer.
This is why is so important that your consultant have experience in fulfilling complete and accurate applications, so your products will be approved faster. For more information contact us.
We will be discussing in the future the updates on the regulation, to be up to date, please subscribe to our newsletter, link on the footer.
UNOPS fast track registrations.
Equivalence procedures for medical devices.
On November 18th, 2020, Cofepris published very aggressive timelines: 5 working days for registration approval for those new registrations submitted via equivalence procedures.
However, we cannot guarantee that our authorities will actually comply this timing. This approval is only for bids and government sales (UNOPS biding), and it is not applicable for private sales. If you want to sale in private market you can use or not equivalence procedures, but the registration time will be the regular one.
There are 3 recognized equivalence procedures:
- US FDA (they require a 510k + EIR)
- Health Canada
- Japan
We will be discussing in the future the specific requirements for each equivalence procedure, among other updates on the regulation, to be up to date, please subscribe to our newsletter, link on the footer.
For more information about obtaining your registration in Mexico with or without equivalence procedures contact us.