REGULATORY ADVISORY
Our team of experts in regulatory affairs offers complete solutions for the
regularization of your company and its products, in an agile way and within the
highest quality standard.
Check out the main services we offer with the National Health Surveillance Agency -
ANVISA, the National Institute of Metrology, Quality and Technology - INMETRO, the
National Telecommunications Agency - ANATEL and the Ministry of Agriculture,
Livestock and Supply - MAPA:
Classification, registration, or notification of
medical devices, classes I to IV, food, perfumes, hygiene products, cosmetics,
and sanitizing products.
Solufy Brazil Regulatory Affairs team has highly qualified specialists, with the
necessary knowledge in any kind of classification, registration, or notification of
medical devices, food, perfumes, hygiene products, cosmetics, and sanitizing
products, in federal, state, and municipal agencies.
We monitor and advise the processes of registration, post-registration, renewals,
alterations, and adaptations of products, always in accordance with current
legislation. We advise you from the first contact to the end of the process, with
transparency and security at every step, guaranteeing the quality of our
services.
Good Manufacturing Practices - GMP
Some manufacturers and/or importers and distributors of products, whether national
or international, need special authorizations and certificates from ANVISA so that
their products can be marketed in Brazil: the so-called GMP (of Good Manufacturing
Practices).
We are prepared to help with certifications, from the elaboration and assembly of
the process, instructing the company in all stages until its approval by the
competent body.
Our team has highly trained and qualified pharmaceutical specialists, always
focusing on success in the demands of customers with ANVISA.
Support in INMETRO Compulsory Certification and
ANATEL approval
Some products, by their nature, require mandatory INMETRO certification (such as
hypodermic needles, medical and electromedical equipment, surgical and procedure
gloves, and breast implants) or ANATEL approval (such as devices with Bluetooth
connection or other equipment that use radio communication). You can rest assured
while our team takes care of all the requirements to adapt your product to the
national market.