Summary of changes
| Nova | affects | In force in |
| IN 101/2021 | Revoked in IN 6/2011 and in IN 13/2016 | 01/10/2021 |
| DRC 539/2021 | Revoga a RDC 4/2011, a RDC 9/2012, a RDC 29/2014 and a RDC 342/2020 | 01/10/2021 |
| DRC 540/2021 | Revoga a RDC 5/2011, a RDC 7/2012, a RDC 28/2014 and a RDC 344/2020 | 01/10/2021 |
| DRC 541/2021 | Revoga a RDC 3/2011, a RDC 8/2012, a RDC 27/2014 and a RDC 341/2020 | 01/10/2021 |
| DRC 542/2021 | Revokes RDC 97/2000 | 01/10/2021 |
| DRC 543/2021 | Revokes RDC 6/2010 | 01/10/2021 |
| DRC 544/2021 | Revokes RDC 35/2014 | 01/10/2021 |
| DRC 545/2021 | Revokes RDC 27/2013 | 01/10/2021 |
| DRC 546/2021 | Revokes RDC 56/2001 | 01/10/2021 |
| DRC 547/2021 | Revokes RDC 55/2011 and RDC 94/2016. | 01/10/2021 |
| DRC 548/2021 | Revokes RDC 10/2015 | 01/10/2021 |
| DRC 549/2021 | Revokes RDC 27/2011 and Amends RDC 423/2020 | 01/10/2021 |
| DRC 550/2021 | Revokes RDC 16/2012 and RDC 33/2012 | 01/10/2021 |
| DRC 551/2021 | Revokes RDC 23/2012 and RDC 501/2021 | 01/10/2021 |
| DRC 552/2021 | Revokes RDC 69/2009 | 01/10/2021 |
| DRC 553/2021 | Revokes RDC 55/2008 and RDC 64/2016 | 01/10/2021 |
| DRC 554/2021 | Revokes RDC 62/2008 and RDC 276/2019 | 01/10/2021 |
| DRC 555/2021 | Revokes RDC 301/2005 and RDC 104/2006. | 01/10/2021 |
| DRC 556/2021 | Revokes RDC 14/2011 | 01/10/2021 |
| DRC 557/2021 | Alter RDC 67/2009, RDC 448/2020, IN 21/2017, RDC 375/2020, RDC 52/2015, RDC 145/2017 and RDC 173/2017 | 01/10/2021 |
| Revokes IN 3/2010, RDC 3/2010, and RDC 22/2013 | ||
| DRC 562/2021 | Alter RDC 305/2019 | 01/10/2021 |
Description of new RDCs
IN 101/2021
Specific criteria for grouping materials for health use into families for recording and reporting purposes.
Revoked in IN 6/2011 and in IN 13/2016.See document...
DRC 539/2021
Minimum identity and quality requirements for single-use transfusion, gravity infusion and infusion sets for use with an infusion pump.
Revoga a RDC 4/2011, a RDC 9/2012, a RDC 29/2014 and a RDC 342/2020.See document...
DRC 540/2021
Minimum identity and quality requirements for hypodermic needles and gingival needles.
Revoga a RDC 5/2011, a RDC 7/2012, a RDC 28/2014 and a RDC 344/2020. See document...
DRC 541/2021
Minimum identity and quality requirements for single-use sterile hypodermic syringes.
Revoga a RDC 3/2011, a RDC 8/2012, a RDC 27/2014 and a RDC 341/20207. See document...
DRC 542/2021
Define "grupo de produtos" aos quais se aplica o item 5.3 do Anexo II da Lei 9.782 de 26
January 1999.
Revokes RDC 97/2000. See document...
DRC 543/2021
It 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 RDC 6/2010. See document...
DRC 544/2021
Plastic bags for the collection, storage and transfer of human blood and its
components.
Revokes RDC 35/2014. See document...
DRC 545/2021
Electronic protocol for issuing a Product Certificate (Notification Certificate
or Medical Device Registration) and Certificate for Foreign Government (Certificate of Notification or
Medical Device Export Registration).
Revokes RDC 27/2013. See document...
DRC 546/2021
Essential safety and efficacy requirements applicable to healthcare products.
Revokes RDC 56/2001. See document...
DRC 547/2021
Minimum identity and quality requirements for surgical gloves and gloves for
non-surgical natural rubber, synthetic rubber, rubber blending procedures
natural and synthetic and polyvinyl chloride, under a health surveillance regime.
Revokes RDC 55/2011 and RDC 94/2016. See document...
DRC 548/2021
Conducting clinical trials with medical devices in Brazil.
Revokes RDC 10/2015. See document...
DRC 549/2021
Procedures for compulsory certification of equipment under the Surveillance regime
Sanitary.
Revokes RDC 27/2011 and Amends RDC 423/2020 See document...
DRC 550/2021
Minimum identity and quality requirements for breast implants and the requirement for
product conformity certification under the Brazilian Conformity Assessment System
(SBAC).
Revokes RDC 16/2012 and RDC 33/2012. See document...
DRC 551/2021
Mandatory execution and notification of field actions by health product registration holders in Brazil.
Revokes RDC 23/2012 and RDC 501/2021. See document...
DRC 552/2021
Registration, manufacturing, quality control, marketing and use of Intrauterine Device (IUD) containing copper.
Revokes RDC 69/2009. See document...
DRC 553/2021
Registration of products used in the procedure for permanent artificial pigmentation of the skin.
Revokes RDC 55/2008 and RDC 64/2016. See document...
DRC 554/2021
Minimum requirements that Male Natural Rubber Latex Condoms must meet.
Revokes RDC 62/2008 and RDC 276/2019. See document...
DRC 555/2021
Enquadramento do "Reagente Limulus Amebocyte Lysate (LAL)" no Regulamento Técnico sobre produtos médicos.
Revokes RDC 301/2005 and RDC 104/2006.. See document...
DRC 556/2021
Requirements for grouping materials for health use for registration and notification purposes at the National Health Surveillance Agency and adopts traceability labels for implantable products.
Revokes RDC 14/2011. See document...
DRC 557/2021
Alters and revokes normative acts that are part of the fourth stage of the process of reviewing and consolidating normative acts within the scope of Anvisa.
Alter RDC 67/2009, RDC 448/2020, IN 21/2017, RDC 375/2020, RDC 52/2015, RDC 145/2017 and RDC 173/2017.
Revokes IN 3/2010, RDC 3/2010, and RDC 22/2013. See document...
DRC 562/2021
Changes the Collegiate Board Resolution - RDC No. 305/2019. Exemption from Regulatory Impact Analysis (AIR) for low impact and for dealing with urgent situations.
Alter RDC 305/2011. See document...
Sources:
-http://antigo.anvisa.gov.br/legislacao
-Health products library
-Library of transversal themes