As a result of the health emergency declared by Decree No. 3456/2020, this resolution authorizes health service providers and medical professionals to provide remote health services for promotion, prevention, diagnosis, treatment, and rehabilitation through the use of information and telecommunication technologies, with the purpose of improving access to and the timeliness the services provided to the population, without detriment to those who require personalized attention
Creates the National Telehealth Program, with implementing regulations in SG Resolution No. 367/2020
Legal validity of electronic signatures, digital signatures, data messages, and electronic files (amended by Law No. 4610)
On health products and other similar items. This law regulates the manufacture, preparation, fractionation, quality control, distribution, prescription, dispensation, commercialization, representation, import, export, storage, rational use, pricing, information, advertising, evaluation, authorization, and registration of medicines for human use, drugs, chemical products, reagents, and all other products for use and application in human medicine, as well as products classified as cosmetics and household cleaning products
The law implements safety procedures and mechanisms and risk prevention mechanisms for health professionals. It defines a medical device as instruments, apparatuses, hospital supplies, and other items, including their packaging and the raw materials, components, parts, or accessories that comprise them, to be used alone or in combination with each other for human beings. They are primarily intended for the diagnosis, prevention, monitoring, treatment, and alleviation of disease, injury, or disability. They are also used in research, replacement or modification of the anatomy, physiological processes, and the control of conception. Types include: I) Active medical device: any device whose operation depends on a source of electrical energy or any source of energy other than that generated directly by the human body or by gravity, and which acts by converting that energy. II) Invasive medical device: any device that, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body. III) Surgically invasive medical device: any device that penetrates inside the body through the surface of the body by means of a surgical intervention.
Mercosur Technical Regulations for the Registration of Medical Devices (Repealing GMC Resolution No. 37/96 added to the national legal system by Decree No. 5939/2005)
Regulates the functions of the state in relation to comprehensive health care for its people and people's related rights and obligations