2023-12-20 23:00:17
In all procedures, as in Medicine, a constant is updating. With this principle, the Federal Commission for the Protection against Health Risks (Cofepris) announced the new guides for applying for health registration of medical devices and for entering information from the application for health registration of medicines.
What are the changes?
The guide to medical devices It contains the essential requirements, as well as the scientific, technical and legal information that they must comply with, which are classified as I, II and III, depending on their risk level.
Medical software (ScDM) is also included to demonstrate its safety and effectiveness. Likewise, it seeks to facilitate the way of including information in the corresponding dossier, thus simplifying the process for applicants.
For its part, the guide for entering information in the application for health registration of medicines contains the comparison guide for the proper health registration of generic medicines, new and innovative molecules, as well as biological medicines and vaccines.
The new health registration guides seek to speed up entry and resolution times
The transparency of these criteria aims speed up entry and resolution times. This will allow the population to expeditiously access health supplies, ranging from diagnosis to prevention, surveillance or monitoring of diseases, as well as replacement, modification or support of the anatomy or a physiological process, among other benefits that they provide. these inputs.
Starting in 2005, the health records They are valid for five years, with the possibility of being extended according to the provisions of the Ministry of Health (SSa), through an online electronic procedure through the platform. Digipris.
The required procedures can be verified in the Federal Registry of Procedures and Services of the Federal Commission for Regulatory Improvement (Conamer).
Cofepris transparent requirements card for authorization of medicines ????and medical devices ????
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— COFEPRIS (@COFEPRIS) December 20, 2023
The creation and publication of this guide It is an exercise in transparency by this authority towards the industries subject to regulation and towards patients, the central objective of an agile, fair and transparent health agency, promoting the continuous development of technological innovations in the Health sector.
Most important points
In an unprecedented event, a comparison guide for health registration of medications and medical devices, including software, is published. Now the user will know 100% of the evaluation process and service times. It marks an end to the era of opacity that predominated in obtaining health records.
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