Brazil - Anvisa Resolution RDC No 340/2020 Updating Information Requirements of Medical Devices and IVD Equipment Registration Procedures

Business description

The Anvisa (Brazilian Health Agency) issued the Resolution RDC 340/2020 to classify and establish procedures for changing information in medical device regularization processes.

After April 1st 2020 all changes in information presented in the medical device regularization process will have to be classified as:
I - change of approval required;
II - change in immediate implementation; and
III - non-reportable change.

The Resolution RDC 340/2020 cancels and replace the item 1, Part 4 of Anvisa Resolution RDC 185/2001.

Source: Anvisa RDC 340/2020

Countries:

Brazil

Technical aspects:

Certification / Approval / Test Mark

Business fields:

P.05 Medical

Regions:

South-America

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