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the authority-duty of issuing them. The Federal Constitution outlines the
Public Administration publics in its article 37 and, in its article 87, it puts
the Ministries of State in charge of issuing guidelines for enforcing laws,
decrees, and regulations, in the situation now examined.
Law No. 8.080/90
22
was regulated by administrative acts from the Public
Authority, specifically by the Administrative Rule GM/MS 3523, related to
technicaldevices thatwereput inthe legalworldbyResolutionNo. 09ofANVISA.
ANVISA is Agência Nacional de Vigilância Sanitária (National Agency
of Sanitary Surveillance), an autarchy linked to theMinistry ofHealth, which
was created to protect the citizen’s health through the sanitary control of
manufacturing and commercialization of products and services subjected
to sanitary surveillance, among other attributions.
And Resolution No. 09 was generated by this sanitary police power24
and through one of its technical chambers.
As an administrative act, the Resolution No. 09 of ANVISA has the
features of coercitivity- and instancy. Thus, non compliance with it implies
the application of sanctions.
ANVISA has wide police power, as well as normative power in technical
areasrequiringknowledgespecializedinthesubject.Thisautarchyrepresents
the progress in the performance of the sanitary police power by the Union.
Resolution No. 9 of ANVISA presents referential quality standards for the
air inside artificially acclimatized environments for public and collective use.
All rules in this resolution, presenting specific technical content, must
be followed under penalty of legal impositions, referring to its instancy. This
happens because the article 9 of Administrative Rule GM/MS No. 3.523 for
the linked Resolution No 09 adduces:
