On September 16, 2021, the Ministry of Health published in the Official Gazette Exempt Decree No. 42, dated August 31, 2021 (hereinafter the “Decree”), which incorporates portable automatic external defibrillators into the sanitary control regime established in article 111 of the Sanitary Code and in the Regulations for the Control of Products and Elements for Medical Use, approved by Decree No. 825 of 1998 of the Ministry of Health.
These defibrillators correspond to medical devices designed to analyze the heart rhythm, identify fatal arrhythmias and administer an electric shock, if necessary, in order to restore a viable heart rhythm, with high levels of safety.
In addition, with respect to these medical devices, the Decree states that:
a. For the purposes of verification of conformity and corresponding certification, the portable automatic external defibrillators shall be grouped in class IV, in accordance with article 20 of the Regulation.
b. The verification of conformity shall be carried out by means of the review of background information and documents required in Title IV of the Regulation.
c. The certificate of verification of conformity shall be granted by an entity authorized by the Institute of Public Health or by the latter in its absence.
Finally, it is established that this Decree will become effective 6 months after its publication in the Official Gazette.