ANVISA Introduces Streamlined Market Access for Low-Risk Medical Devices

Published March 1, 2019/Brazil

ANVISA Regulation for Low-Risk Devices

Brazil’s medical device regulator, ANVISA, has issued a new regulation for a notification or registration market pathway, providing streamlined market access for low-risk devices.

ANVISA regulation RDC 270/2019 will enter into force in May 2019. Under this new pathway, Class I devices will not be required to undergo the full registration and approval process, allowing for faster access to the Brazilian market for qualifying products.

For more details, you can refer to the official document: ANVISA RDC 270/2019 - http://portal.anvisa.gov.br/documents/10181/3741322/RDC_270_2019_.pdf/c7b53ecb-21ba-4c6a-846a-ea9e4aca690d.

Brazil Quick Facts

Regulatory Agency	ANATEL (Agência Nacional de Telecomunicações)
Certification Type	Mandatory
License Validity	Technical compliance certificate: 2 to 3 years
Application Language	Portuguese
Legal License Holder	Required
In-country Testing Requirement	Requires testing

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