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Regulatory ESSENTIAL
Brazil - In-Vitro Diagnostics

Modular information package with all the essential information for compliant products in your target market.
Conveniently read online at Product-Compliance-Portal ROGER WILLCO.

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Stakeholders:      Manufacturer, Importer     
Application: Manufacturer, Importer Brazil, In-Vitro-Diagnostics, ANVISA Notification and Registration
Countries: Image for BR Brazil,  
#3o6g  
Status: Published 2023-03-28 by Anette Dunkel-Reinboth and Benjamin Kerger
Last change 2024-02-26 by Anette Dunkel-Reinboth: Scope of this ESSENTIAL, In Vitro Diagnostic (IVD)
   
Price 365 day licence for 695.00 € net         Buy this REGULATORY ESSENTIAL >>

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Subject Areas of this Essential:


In Vitro Diagnostic (IVD)

Scope of this ESSENTIAL
NOTE: This ESSENTIAL is based on the ANVISA RDC 36/2015, valid until 31-MAY-2024.
Starting 01-JUN-2024, the new RDC 830/2023 will come into force.

This ESSENTIAL describes the regulatory requirements of In-Vitro Diagnostics in Brazil, based on the
- ANVISA Resolutions
- Additional information from Brazilian authorities webpages

IVD products are classified into four risk classes, according to the risk associated with their use (RDC 36/2015 - Art.4):
Class I: products of low risk to the individual and low risk to public health;
Class II: products of medium risk to the individual and low risk to public health;
Class III: products of high risk to the individual and or medium risk to public health; It is
Class IV: products of high risk to the individual and high risk to public health.

Not in scope of this CRF: Medical Devices (please see: ESSENTIAL BRA Medical Devices)'

Analysis of regulatory requirements

Legislation in force for this PCT
here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO licence)

Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Responsible actors
here you will get textual information

Which actor(s) are responsible for compliance with the legal provisions: e. g. - economic operators (manufacturer, importer, distributor, fulfilment service provider), - user (commercial/industrial/professional), - user (private, consumer)?

Regulatory market access conditions for the actor(s)
here you will get textual information

What are the main regulatory requirements (e. g. conformity assessment fulfilment of essential requirements of Annex I 2006/42/EC) prior placing on the market, importation and putting into service (brief description)

Exemption clauses
here you will get textual information

Exempted devices/products or industry sectors.

Sub-federal legislation of states/counties
here you will get textual information

E. g. by 2019 an Inter-Governmental Agreement (IGA) on governance of the Electrical Equipment Safety System (EESS) has been signed by Queensland, Victoria, Western Australia and Tasmania.

FTA/MRA status with EU
here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO licence)

Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority
here you will get textual information

Name of the authority for approval, registration, market surveillance and/or enforcement

Link/Reference to other reference document(s)
here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO licence)

Abbreviations
here you will get a table

Important abbreviations which are special for this legislation or theme.

Route to compliance

Formal and administrative requirements

Registration at related authority required?
here you will get textual information

Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?
here you will get textual information

[Yes/No]

IMDRF Membership
here you will get textual information

Established in October 2011, the IMDRF is a forum for medical device regulators from multiple jurisdictions who have agreed to work together to promote international harmonization and convergence in the medical device field. The IMDRF builds on the foundational work of the Global Harmonization Task Force (GHTF), which was established in 1992 with the EU as one of the founding members.

Database Entry required
here you will get textual information

Hints
here you will get textual information

Specific recommendations, information or most common mistakes

Equipment authorization (approval process)

Classification Rules
here you will get textual information

Approval process (conformity assessment procedure)
here you will get textual information

Means each legally required approval process prior placing on the market, importation or putting into service

Conformance document(s) to show compliance to the authority
here you will get textual information

e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)

Conformance document validity and renewal
here you will get textual information

Validity for Conformance document name mentioned. For mandatory certification validity is important.

Which documents are required by an approval body?
here you will get textual information

e .g. formal application

Is a factory inspection legally required
here you will get textual information

Hints
here you will get textual information

Specific recommendations, information or most common mistakes

Testing & Standards

General information to the application of standards
here you will get textual information

e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"

Source for standards for conformity assessment
here you will get textual information

Acceptance of foreign test reports
here you will get textual information

Hints
here you will get textual information

Specific recommendations, information or most common mistakes

Regulatory labelling, markings and user information

Regulatory label (mandatory)
here you will get a image or chart

e. g. product label

UDI marking
here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO licence)

Regulatory e-labelling allowed?
here you will get textual information

e. g. put the regulatory information and labels in a software menu

Required information on the product and/or packaging
here you will get textual information

e. g. address of the manufacturer/importer, serial number

User instructions language(s)
here you will get textual information

Regulated by the legal provisions

User instruction requirements and specific compliance notes
here you will get textual information

Form, sentence inside, simple text. E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste

Medical Device Symbols
here you will get textual information

General Information:

   Brazil

Code, ContinentBRA, South America
Economic AreaMERCOSUR/MERCOSUL
Official LanguagePortugese - Constitution of 1988, Article 13 | https://www.jusbrasil.com.br/topicos/10640315/artigo-13-da-constituicao-federal-de-1988
Standard InstituteABNT (Associação Brasileira de Normas Técnicas) | https://www.abnt.org.br/
HS CodememberYes, since 1981

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