In recent months, COFEPRIS has been experiencing a series of changes with the aim of attending overdue requests. In this article, we will focus on three fundamental events that are already being executed leading to a quicker renewal process for sanitary registrations:
- In May 2021, the Ministry of Health in Mexico updated the Health Supplies Regulation affecting the renewal processes for Medical Sanitary Registrations.
- By late 2021, COFEPRIS also launched its platform for digital procedures called DIGIPRiS, which has been partly working for some procedures, including Medical Device Sanitary Registration renewals.
- In January 2022, the Agreement for Procedures and Services was updated to match the recent changes on regulations and officially include digital procedures through the use of DIGIPRIS.
It is worth mentioning that the May 2021 update (referred in point 1) contemplates less requirements for the first-time Sanitary Registration renewals. This document also considers that requests submitted physically to COFEPRIS before May 2021 without response up to date, can be evaluated under the new criteria by leveraging a digital submission through DIGIPRIS, looking forward to receiving a response in a shortened timeframe (no double payment of fees would be required).
As explained in a COFEPRIS public video session project called EducaPRIS, the workflow and schedule for overdue renewals is established with the aid of a calendar to make a faster process. This calendar is suggesting dates to re-submit the applications for renewals via DIGIPRIS for requests submitted before 2019 and during 2020 (2021 to be announced), which are considered seriously belated. In other words, it is not clear whether COFEPRIS will still attend processes submitted physically before 2020, but they are encouraging companies to purse the new submission route as a manner to expedite the process.
Even when the local regulation considers that a Sanitary Registration remains valid as long as the renewal is requested to COFEPRIS, some manufacturers, registration holders, or distributors usually need to perform modifications to sanitary registrations while the application of renewal is still in progress. That is one of the reasons these new alternative becomes attractive for applicants.
It is true that there is still a path ahead to walk on in order to have a fully digital process, but if you want to know more about COFEPRIS new regulations and the process to submit digital requests through DIGIPRIS, please contact us at contact@veraqueconsulting.com.
