New guidelines for the acquisition and manufacture of fans, during the current health emergency of COVID-19.
April 30, 2020
The Ministry of Health, through the Federal Commission for Protection Against Sanitary Risks (COFEPRIS) published the new “Guidelines for the acquisition and manufacture of fans during the public health emergency due to the coronavirus 2019 (COVID- 19)“, which will be in force only during the public health emergency related to COVID-19.
These provisions are the results of COFEPRIS collaboration with various institutions, such as the World Health Organization, the Pan American Health Organization (WHO- PAHO), the National Center for Health Technology Excellence (CENETEC), among others.
In this regard, the guidelines aim to face the public health emergency, by expanding the availability of safe and effective medical devices that provide care for patients requiring respiratory support.
Health facilities are required to use conventional fans with a marketing authorization granted by COFEPRIS, however, these provisions contemplate the minimum criteria to obtain the authorization to import and even manufacture fans for their marketing in Mexico.
On the other hand, COFEPRIS informed that the submission of requests in relation to importation and exportation is currently available.
OLIVARES is carefully reviewing these new provisions and any other guidance or guidelines that could be implemented by the Mexican government during this health emergency, in order to advise clients on legal measures related to COVID-19.