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ANVISA – 25 RDCs and 1 IN come into force

Date: 10/04/2021

25 Collegiate Board Resolutions (RDCs) and one Normative Instruction (IN) that were published by ANVISA on 08/31/2021 came into force on October 1st, 2021.

The publications are part of the 4th stage of the review and consolidation process of the Agency’s normative acts, in compliance with Decree 10,139 / 2019 – known as the Revision Decree.

It is important to clarify that the new standards do not present technical changes in their content. The revision improves the legislative technique and the wording, updates normative terms and references and eliminates obsolete provisions, among other measures.

See the list of normative acts for the medical devices’ area:

*Resolution – RDC No. 539/2021: Establishes the minimum identity and quality requirements for Transfusion sets for single use with pressure infusion apparatus, gravitational infusion and infusion equipment for use with an infusion pump.
Revokes and replaces Resolutions – RDC No. 4/2011, RDC No. 9/2011, RDC No. 29/2014 and RDC No. 342/2020.

*Resolution – RDC No. 540/2021: Establishes the minimum identity and quality requirements for hypodermic needles and gingival needles.
Revokes and replaces Resolutions – RDC No. 5/2011, RDC No. 7/2012, RDC No. 28/2014 and RDC No. 344/2020

*Resolution – RDC No. 541/2021: Establishes the minimum identity and quality requirements for single-use sterile hypodermic syringes.
Revokes and replaces Resolutions – RDC No. 3/2011, RDC No. 8/2012, RDC No. 27/2014 and RDC No. 341/2020

*Resolution – RDC nº 542/2021: Defines “group of products” to which item 5.3 of Annex II of Law 9,782 of January 26^th, 1999 applies.
Revokes and replaces Resolution – RDC No. 97/2000

*Resolution – RDC nº 543/2021: Extends the application of notification of medical devices to textile yarns with thermal properties, indicated for the composition of garments with therapeutic, beautifying or aesthetic correction effects.
Revokes and replaces Resolution – RDC No. 6/2010

*Resolution – RDC No. 544/2021: Addresses plastic bags for the collection, storage and transfer of human blood and its components.
Revokes and replaces Resolution – RDC No. 35/2014

*Resolution – RDC No. 555/2021: Addresses the framing of the “Limulus Amebocyte Lysate (LAL) Reagent” in the medical devices’ Technical Regulation – Resolution – RDC No. 185, of October 22^nd, 2001.
Revokes and replaces Resolutions – RDC No. 301/2005 and RDC No. 104/2006

*Resolution – RDC No. 556/2021: Provides the grouping requirements for materials for health use for the purposes of Registro and Notification in the National Health Surveillance Agency, and adopts traceability labels for implantable devices.
Revokes and replaces Resolution – RDC No. 14/2011

*Normative Instruction – IN No.101/2021: Establishes specific criteria for grouping materials for health use into families for Registro and Notification purposes.
Revokes and replaces Normative Instructions – IN No. 6/2011 and IN No. 13/2016

*Resolution – RDC No. 557/2021: Alters, revokes and replaces normative acts that are part of the fourth stage of the review and consolidation process of normative acts within the scope of ANVISA, in compliance with Ordinance No. 201/GADIP-DP/ANVISA, of 20th February 2020, and Decree No. 10.139, of November 28th, 2019.
Alters Normative Instruction – IN No. 21/2017
Amends Resolutions – RDC No. 67/2009, RDC No. 52/2015, RDC No. 145/2017, RDC No. 173/2017, RDC No. 375/2020 and RDC No. 448/2020
Revokes Normative Instructions – IN No. 3/2010, IN No. 7/2011 and IN No. 1/2013
Revokes Resolutions – RDC No. 3/2010, RDC No. 22/2013, RDC No. 348/2020, RDC No. 356/2020 and RDC No. 379/2020

*Resolution – RDC No. 560/2021: Addresses the organization of health surveillance actions, carried out by the Union, States, Federal District and Municipalities, related to the Operating Permit, Licensing, Registration, Good practices Certificate, Inspection and Standardization, within the scope of the National Health Surveillance System – SNVS.
Revokes and replaces Resolutions – RDC No. 207/2018, RDC No. 215/2018 and RDC No. 259/2018

DOMO Salute’s team will remain attentive to the Brazilian Regulatory Agencies movements and is available to clarify any doubts concerning the recent changes.

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