Brazil - Anvisa Resolution RDC 342/2020 Updating Minimum Identity and Quality Requirements for Single-use Transfusion, Gravitational Infusion and Infusion Equipment for Use with an Infusion Pump
Business description
The Resolution RDC 342/2020 entries into force after April 1st 2020 and the single-use transfusion, gravitational infusion and infusion equipment for use with an infusion pump will have a transition period for adaptation:
- Registered products: the manufacturers and importers have 1 year after April 1st 2020 to certify the single-use transfusion sets for use with an infusion pump according to SBAC rules (Brazilian Conformity Assessment System).
- For Article 12-C of RDC 342/2020 (luer connector compliance with technical standards NBR ISO 594-1 and/or NBR ISO 594-2 or ISO 80369-7):
1) New products: 3 (three) years after April 1st 2020
2) Registered products: 5 (five) years after April 1st 2020.
The Resolution RDC 342/2020 cancels and replace the Article 2nd of Anvisa Resolution RDC 029/2014.
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