As reported last September 2020, COFEPRIS has kept its digitalization strategy with the solid conviction to optimize the approval process for both medical devices and pharmaceutics. In this stage, COFEPRIS announced the platform DIGIPRiS. In this article, we will describe more details about how this digital alternative works and for which regulatory processes is applicable.
The digital system DIGIPRiS is composed by two main interfaces:
- Self-managing processes: which means that a digital submission and resolution is fully digitalized. For instance, a warehouse notice amendment, which was hardly ever resolved in a single visit to COFEPRIS, can be now submitted and solved through DIGIPRis.
- According to the Authority data, this will free up to 30% of the appointments requested daily and all the associated workload.
- Electronic submissions: which is the beginning of a fully digital system lead by a regulatory precision to eliminate bureaucratic stages but still focusing on the legal and technical compliance. The first step of this process is applicable for renewals. As mentioned in our Regulatory Affairs Guidelines, a registration is valid for up to 5 years and the Holder should apply for the renewal 150 days prior to the expiration date. From now on, this process is fully digitalized through this website.
- It is worth mentioning that this is aligned with the latest renewal scheme published last May 31st 2021, on which the registrations have to be renewed just once to be valid for a lifetime.
Therefore, DIGIPRis is another milestone for which COFEPRIS keeps a consistent pace towards a fully digitalized agency. It is worth mentioning, that although this mode facilitates the way to submit, the Ministry of Health is yet in charge of assuring the quality, safety and efficacy of the products to be sold in the country.