2023-08-21 18:00:30
During what has elapsed in 2023, Cofepris has authorized 1,588 health registrations of new medical devices.
The figure is 125% higher than that achieved in the same period of 2022.
In addition, 2,937 procedures for modifications to the conditions of sanitary registration and more than 3,450 procedures for extensions have been attended.
One of the most important authorities in our country is the Federal Commission for the Protection against Sanitary Risks (Cofepris). As part of his recent work, he has focused on expediting attention to authorizations and procedures regarding medical devices for the benefit of the health and quality of life of the population.
What is a medical device?
According to the Official Mexican Standard NOM-240-SSA1-2012 It is the substance or mixture of substances, material, apparatus or instrument used alone or in combination in the diagnosis, monitoring or prevention of diseases in humans or auxiliaries in the treatment of the same and disability, as well as those used in the replacement , correction, restoration or modification of the anatomy or of human physiological processes.
With this in mind, the cofepris announced that so far in 2023, 3,285 health registration procedures have been attended, of which 1,588 new medical devices have been authorized, that is, 125 percent more authorizations than the same period in 2022.
He also said that 2,937 procedures for modifications to the conditions of sanitary registration and more than 3,450 procedures for extensions have been attended to. With these figures, it is projected that the attention to procedures will more than double by the end of the year. It is important to note that 88 percent of the procedures attended to have been approved.
Transactions carried out digitally
In 2022, this health authority handled more than 2,400 procedures for the sanitary registration of medical devices, 1,363 modification procedures and 5,556 extensions managed at windows through the Comprehensive Services Center (CIS), as well as digitally through of the portal Digipris.
For its part, every two weeks Cofepris publishes the fortnightly Report on therapeutic expansion, which systematically discloses the list of authorized medicines and medical devices under the highest technical and scientific rigor. This information is available at this link.
As part of the work carried out within the framework of the T-MEC, in the field of medical devices, the NOM-241-SSA1-2021 Good Manufacturing Practices for Medical Devices. It entered into force in June of this year to exercise sanitary control in manufacturing establishments, packaging warehouses, and distribution of medical devices, compliance with which is permanently monitored by this health authority.
Likewise, the results of the Single Audit Program for Medical Devices (MDSAP) and is currently working on the project to strengthen the Equivalence Agreement.
Through the Executive Directorate for Authorization of Products and Establishments, this health authority implements highly efficient strategies and organizational actions among the ruling, administrative, legal, and management personnel. Likewise, the staff has increased by more than 50 percent.
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