Regulation for healthcare facilities

Recently, new ordinances have established the technical requirements for licensing, installation, organization and functioning of certain types of healthcare services.

Regardless of the technical requirements that may vary for each type, the most significant and long-awaited change introduced by these ordinances is their scope as they now also apply to public healthcare units, military institutions and private social solidarity institutions (“IPSS”) that provide healthcare services.

The technical requirements for opening and operating certain types of healthcare services are now applicable to all healthcare providers, regardless of their legal nature: i) dental clinics and offices; ii) nursing homes; iii) private units of physical medicine and rehabilitation, physiotherapy, speech therapy and occupational therapy; iv) medical clinics and offices; v) units with inpatient services; vi) day surgery units; vii) dialysis units; viii) nuclear medicine units; ix) radio-oncology units; x) radiology units; xi) pathological anatomy laboratories; and xii) medical genetics laboratories.

In spite of this innovation, verification of these requirements for public healthcare units, military institutions and IPSS depends on a declaration of conformity. However, the procedure for obtaining the declaration of conformity is yet to be defined by ordinance of the Minister of Health jointly with the Ministers of Defense and Social Security, as appropriate.

The ordinances came into force on March 2, 2024, but they establish a five-year period for private healthcare units already licensed under the previous rules to adapt to the new technical requirements. Public healthcare units, military institutions and IPSS have the same period to adaptation. Healthcare units that are currently undergoing a licensing process may choose to comply with the new technical requirements by submitting a request to the Health Regulatory Authority (Entidade Reguladora da Saúde - ERS).