Equipe
Regulatórios

EQUIPE REGULATÓRIOS is a Portuguese name for regulatory team. This is a ten (10) Years old Brazilian company, formed by a team of experienced professionals in regulatory affairs and dedicated to solve issues related to health products on Brazil. We are specialized in consutancy for market evaluation, open new business, registering new companies and/or new products on Brazil and supporting on issues related to internalization of products.

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Health products are those products subject to the health surveillance regime, including all medical devices (or medical products). In a free translation of the ANVISA`s RDC nº 751, 15/September/2022, art. 4º it is find the following definition:

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“medical device (medical product); any instrument, apparatus, equipment, implant, in vitro diagnostic medical device, software, material or other article, intended by the manufacturer to be used, alone or together, in humans, for any of the following specific medical purposes, and whose main action intended action is not achieved by pharmacological, immunological or metabolic means in the human body, but can be assisted in its intended action by such means:

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a) diagnosis, prevention, monitoring, treatment (or relief) of a disease;

 

b) diagnosis, monitoring, treatment or repair of an injury or disability;

 

c) investigation, replacement, alteration of anatomy or a physiological or pathological process or state;

 

d) support or maintenance of life;

 

e) control or support for design; or

 

f) provision of information through in vitro examination of samples from the human body, including organ and tissue donations.”