Regulatory ESSENTIAL



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

In vitro diagnostic; IVD devices; IVD devices; CMDE; Electronic registration; NMPA; UDI regulation; UDI Code; IMDRF; Classification Rule; ISO 15223-1 symbol; vigilance
Scope: 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 CRF 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 ESSENTIAL: Medical Devices (please see: ESS BRA Medical Devices)

Stakeholders: Manufacturer, Importer, B2C products, B2B products
Legislation in force: Abbreviation: RDC 36/2015 Risk classification, notification, registration control regimes and labeling requirements and instructions for use of in vitro diagnostic products, including their instruments. Art. 2 This Resolution applies to in vitro diagnostic products manufactured in the national territory and those manufactured in other countries that may be imported into Brazil. Section II of the Resolution lists the Classification Rules. ANVISA RDC No. 665 of 30-MAR-2022 Good Manufacturing Practices for Medical Products and In Vitro Diagnostic Products. Article 1. This regulation provides for the Good Manufacturing Practices (GMP) for Medical Products and In Vitro Diagnostic Products, establishing the requirements that describe the GMP for methods and controls used in the design, purchasing, manufacturing, packaging, labeling, storage, distribution, installation, and technical assistance applicable to the manufacture of medical products and in vitrodiagnostic products. Article 2. This regulation applies to manufacturers, distributors, storers, and importers of medical products and In Vitro Diagnostic products that are commercialized in Brazil. Definitions: II - quality audit: an established, systematic, and independent examination of a manufacturer's entire quality system, performed at regular intervals and with sufficient frequency to ensure that the quality system’s activities and its results comply with the procedures specified in its quality system. (amended by ANVISA NI No. 30:2019) Art. 1 - This Normative Instruction regulates item I of art. 20 of the Resolution of the Collegiate Board of Directors-RDC No. 36, of August 26, 2015, which provides for the risk classification, the notification and registration control regimes and the labeling requirements and instructions for use of in vitro diagnostic products, including its instruments and other provisions. Art 2 - Products from the same legal manufacturer, with similar characteristics of technology, methodology and indication, may be registered or registered as a family of products, provided that they are included in the same group as determined in this Normative Instruction. Resolution - RE No. 392 of 20/02/2018 Recognizes the Medical Device Single Audit Program (MDSAP) to support health inspection and inspection actions.

Application national: Manufacturer, Importer Brazil, In-Vitro-Diagnostics, ANVISA Notification and Registration

Countries: Image for BR Brazil,  
Status: Published 2023-03-28 by Anette Dunkel-Reinboth and Benjamin Kerger
Last change 2024-06-25 by Torsten Sahm: Scope of this ESSENTIAL, In Vitro Diagnostic (IVD)
ROGER WILLCO ID: #3o6g
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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, 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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