Brazil - Anvisa Resolution RDC 344/2020 Updating Minimum Identity and Quality Requirements for Hypodermic Needles and Gingival Needles

​The Anvisa (Brazilian Health Agency) issued the Resolution RDC 344/2020 updating the minimum identity and quality requirements for single-use hypodermic needles and gingival needles by changing specific articles from the Resolution RDC 005/2011.
The Resolution RDC 344/2020 entries into force after April 1st 2020 and the single-use hypodermic needles and gingival needles will have a transition period for adaptation of Article 15 (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.