Medical Devices and more
As the largest healthcare market in Latin America, Brazil attracts more and more manufacturers. We support you in the registration process of medical devices in Brazil as well as gaining market access for your medical devices and in-vitro diagnostic medical devices (IVDs) at every step on the way and help you to remain compliant in the evolving regulatory landscape.
However, if medical devices is not your business, you don't need to move on to search for another consultant. We also support you when it comes to crop protection / nutrition, biocides, chemicals and animal health questions. Take advantage of our global setup: our local experts can draw on a pool of more than 400 regulatory and scientific knoell experts to develop the best solutions for you.
Knoell Brazil Consultoria Ltda.
Avenida das Nações Unidas, 14.401 | Andar 21, conjunto 09 - Chácara Santo Antônio | 04794-000 São Paulo
our solutions for MEdical Devices
ALF - Company operating permit I Mayor‘s office
(Auto de licença de funcionamento)
- In the city of São Paulo, established by law nº 49.969, as of 28 August 2008
- Document issued by the Mayor’s office, allows the company to operate and to carry out its activities under local laws (only for companies established in São Paulo)
LF - Company operating permit I Municipal / State Health Agency
- Distributor CMVS – Portaria 2215/2016 – SMS.G
- Manufacturer LF – CVS 1, as of 9 January 2019
- Document issued by the competent health agency authorising a company to operate in an establishment of the health sector or the use of ionizing radiation sources
AFE - Company operating permit I Federal Health Agency (ANVISA)
(Autorização de funcionamento)
- RDC 16, as of 2014
- A legal act that allows the operation of companies or establishments, institutions and bodies subject to sanitary agency, through compliance with technical and administrative requirements specific to the sanitary legal and regulatory frameworks
- RDC 270 / 2019
- Act of communicating to ANVISA the intention to commercialise a medical product; intended to prove the permission to manufacture and import a medical product exempt from registration, classified as low risk class I.
- RDC 40, as of 2015
- Private act of ANVISA, after evaluation and dispatch by its manager; intended to prove the permission to manufacture and import medical products exempt from registration and classified as medium risk class II.
- RDC 185, as of 2001
- A legal act that recognises the suitability of a product to the health legislation and its concession is given by ANVISA. It is a control made before the commercialisation, being used in the case of products that may present possible health risks.
knoell Brazil at the Medical Talks Live 2020!
Instead of the unfortunately cancelled Medical Fair Brazil 2020, medical talks were held and recorded. Maik Endler (Managing Director knoell Brazil) talked about challenges on the Brazilian market for Brazilian and international companies