Scope of this ESSENTIAL

NOTE: This ESSENTIAL is based on the ANVISA RDC 830/2023, which will come into force on 01-JUN-2024. The former ANVISA RDC 36/2015 will be repealed on 31-MAY-2024. 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 830/2023, Chapter II) Class I: low risk to the individual and low risk to public health; Class II: medium risk to the individual and/or low risk to public health; Class III: high risk to the individual and/or medium risk to public health; It is Class IV: high risk to the individual and high risk to public health. Not in scope of this ESSENTIAL: Medical Devices (please see: ESS 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 license) Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Scope of legislation

ANVISA RDC 830/2023: - it will come into force on 01-JUN-2024 - it replaces the former ANVISA RDC 36/2015 Resolution regarding IVD products. - the transitional time: 1 year - New: Uploading instructions for use in the Documentary Repository of Medical Devices (see: Section VIII - Documentary Repository of Medical Devices)'

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)

Penalty by this legislation

Here you will get textual information What are the possible penalties (e. g. sales ban, fines) in the case of non-compliance?

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 license) 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

Market surveillance authority

Here you will get related hyperlink(s) Name of the authority for market surveillance and/or enforcement

Comment on the comparability to EU legislation

Here you will get textual information

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

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

Approval process (conformity assessment procedure)

Here you will get a table 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

Testing & Standards

Specific requirements for testing

Here you will get textual information e. g. is an accredited test lab. mandatory, limits, test samples, product description

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"

National Standardisation Organisation

Here you will get related hyperlink(s) Link to organisation

Clinical Investigation/Evaluation

Here you will get textual information

Source for standards for conformity assessment

Here you will get related hyperlink(s)

Are national standards based on IEC/ISO standards?

Here you will get textual information Undetailed information

Is in-country testing legally required?

Here you will get textual information

Acceptance of foreign test reports

Here you will get textual information

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 license)

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

Digital user documentation allowed?

Here you will get textual information User instructions allowed by QR-Code/internet or digital medium or integrated in device with display? Safety instruction allowed by QR-Code or digital medium?

Medical Device Symbols

Here you will get textual information

Code, Continent	BRA, South America
Economic Area	MERCOSUR/MERCOSUL
Official Language	Portugese - Constitution of 1988, Article 13 | https://www.jusbrasil.com.br/topicos/10640315/artigo-13-da-constituicao-federal-de-1988
Standard Institute	ABNT (Associação Brasileira de Normas Técnicas) | https://www.abnt.org.br/
HS Codemember	Yes, since 1981