Resolution of the Directive Board (RDC) 431, October 31st, 2020 – ANVISA
ANVISA has published the Resolution of the Directive Board RDC 431/2020 where establishes the loading of instruction for use on the ANVISA website. The loading is MANDATORY and the holder of the product is responsible for imputing and updating the instructions for use. This procedure applies to medical devices of all risk classifications.
The RDC 431/2020 becomes in force from November 1st, 2020. The instructions for use of products regularized until this day must be uploaded to ANVISA’s website within 12 months. The instructions for use for products approved after November 1st must be uploaded within 30 days after the favorable conclusion of the petition or after implementation of the non-reportable change that implies a change in the instructions for use.
The instructions for use uploaded on ANVISA’s website will be available for consultation in the ANVISA’s database. The content of the instructions for use must be under the legislation in force and must be consistent with the regularized product.
In cases of regularized medical devices without a User Manual or similar material, the company must load the label model in the ANVISA’s website, in the instruction for use field.
The lack of uploading of the instruction for use may generate an extra evaluation of documents and taxes by ANVISA at any time. ANVISA also may withdraw the instructions for use of the website, restore an earlier version of the document, or determine other penalties provided for in Law 6.437/1977.
Access the full content of the Resolution in the link below:
RDC Nº 431
For more information and explanations about it, send us an e-mail: [email protected]
Passarini Regulatory Affairs
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