COFEPRIS Challenges 2020

By

Since December 1st, 2018 a historical change in administration that consisted of a new president who is committed to Public Office cleansing of corrupt and unequal practices had a strong impact on the whole country course of operation. Many institutions were eliminated or were audited and restructured. 

Cofepris was audited and analyzed for permanence or removal but was decided to stay active. This, however, caused a complete pause in real operation for almost a whole Quarter of the year; therefore in between 2019-2020, we observed a complete change in staff and certain evaluation criteria.

The main changes to this day include grouping criteria, better answering time for traditional track processes versus previous years and a tendency to avoid any preferential treatment tracks (like Third Authorized Party processes).

Despite initial setbacks, right now answering times are becoming much better than in any previous years which becomes a strong solution given by this administration.

-Copyright 2020 Medisi America. Replication and quote of this content are subject to International Author Law.

Posted in News.
Share

Deja una respuesta

Tu dirección de correo electrónico no será publicada.

Related Posts

  •
    18 junio, 2019

    More than 1 million Class I medical device units recalled in Q1

    For the third consecutive quarter, more than one million Class I units were recalled during 2019’s Q1. If you want to read more about this news click here. If you want to read more about this news click here.

  •
    10 octubre, 2019

    Medtronic announces Infuse spine trial

    Medtronic (NYSE:MDT) said today that it won FDA approval for a clinical trial of its Infuse bone graft in transforaminal lumbar interbody fusion spine procedures. The Minneapolis-based company started recruiting for the prospective, randomized pivotal trial, which is slated to enroll up to 1,000 patients. The TLIF trial would be the second clinical trial for Infuse, …

  •
    18 junio, 2019

    Stroke significantly increases the risk of dementia

    In the largest study of its kind, researchers conclude that stroke doubles the risk that an individual will eventually develop dementia. If you want to read more about this news click here.

  •
    10 octubre, 2019

    Study: Abbott, Edwards may have mislabeled hundreds of patient deaths

    Abbott (NYSE:ABT) and Edwards Lifesciences (NYSE:EW) may have mislabeled patient deaths as injuries or device malfunctions in hundreds of FDA adverse event reports involving their transcatheter aortic or mitral valve replacement devices, according to a new study. The study by JAMA Internal Medicine editor Dr. Rita Redberg, former FDA unique device identification (UDI) external program manager Madris Tomes and others examined a total …