Questions and answers - RDC 751 of 2022
Document of Questions and Answers on the Resolution of the Collegiate Board - RDC No. 751, of September 15, 2022; which rules about risk classification, notification, registration regimes, and labeling/IFUs requirements of medical devices, into force since March 1st, 2023.
User gains platform for reporting adverse events
The novelty is that the e-Notivisa system allows the user to report problems directly to the manufacturer of products subject to sanitary surveillance. Anvisa and the Ministry of Management and Innovation in Public Services (MGISP) launched, on an experimental basis, the e-Notivisa platform. The new online system, allows the user to notify the manufacturer directly of unwanted or unexpected effects (adverse events). In addition, problems with the quality of products subject to sanitary surveillance can be reported.
Collegiate Resolution RDC No. 777
Modifies Collegiate Resolution RDC 751 which provides for risk classification, notification, registration regimes, labeling requirements, and instructions for the use of medical devices. RDC 777 amends Art 2° item 3; Art. 16°, item 1; Arts. 22°, 39°, 43°; and revokes Art. 40.
Anvisa advises on protocol for import of medical devices. From April 17th, 2023, the analysis workflow of import processes will be harmonized and centralized in a single approval post.
The importation of medical devices, subject to or exempt from regularization with Anvisa, including their parts and accessories, must be filed, as of April 17, based on the Resolution of the Collegiate Board ( RDC ) 81/2008 (procedures 4 or 5.5 of Chapter IX of the Annex). With the change, the analysis flows of the import processes will be centralized in a single approval point, facilitating the risk management applied to the products, under the terms of RDC 228/2018.
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