LATEST NEWS

Normative Instruction 49/2019 updates list of Technical Standards for medical device compliance certification

Date: 01/03/2020

In order to approve and update the list of Technical Standards equipment under Health Surveillance must comply with, ANVISA published last November the Normative Instruction number 49, which came into effect immediately after the publication (22^nd November 2019). It is important to highlight that Normative Instructions No. 4 (September 24, 2015), No. 22 (October 20, 2017) and No. 29 (November 27, 2018) have been repealed from this date.

The new list of standards includes updates, additions, and deletions that must be considered for new medical device compliance certification processes (Notification, Cadastro, Registro, , alterations and revalidations).

Most of the additional standards are already in force, with some exceptions such as ISO 7176-1: 2018 and ISO 7176-15: 2009 concerning the determination of static stability and disclosure requirements, documentation and identification of Wheelchair and also IEC 60601-2-2: 2017 regarding the particular requirements for basic safety and essential performance of high frequency surgical equipment and accessories that will come into effect from December 1^st 2020. In addition, ABNT NBR ISO 7176-8: 2018 Standards for Wheelchair Static, Impact and Fatigue Test Requirements and Test Methods, IEC 60601-2-28: 2017 and IEC 60601-2-54: 2018 regarding specific requirements for basic safety and the essential performance of medical diagnostic X-ray tube assemblies as well as radiographic and radioscopic X-ray equipment will be effective only from December 1^st 2021.

You can access the regulation and the list of complete standards through the link:

Portal ANVISA

In case you have any questions regarding the new regulation, please do not hesitate in reaching out to us.

Our experienced team can meet your medical device certification project needs within INMETRO.

Follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

DOMO Salute Team

MORE NEWS

MDSAP Forum: Highlights Include Strategic Discussions, New Member Inductions, and Regulatory Developments

07/18/2024

From June 24 to 28, ANVISA participated in the MDSAP Forum and Regulatory Authority Council (RAC) meeting in Essen, Germany. The event gathered representatives from 27 countries, including regulatory authorities, MDSAP auditing organizations, and industry representatives, with notable attendance from Brazilian associations ABIMED and [...]

ANVISA’s Latest Guidelines and Regulatory Updates for UDI Compliance

07/02/2024

In force since January 2022, RDC 591/2021, which provides for the Unique Device Identification (UDI) system, was amended by ANVISA just days before the deadline for attributing and affixing UDI to risk class IV devices. The amendment was published in RDC 884/2024 on June 1, 2024, and is already in force. According to ANVISA,... Leia [...]

ANVISA implements regulatory reliance mechanisms to streamline the evaluation process of medical devices already approved by Equivalent Foreign Regulatory Authorities (EFRAs)

04/12/2024

Marking a significant advancement in regulatory reliance mechanisms, the National Health Surveillance Agency (ANVISA) published Normative Instruction (IN) 290/2024, on April 8, 2024. This normative introduces an optimized procedure for evaluating and deciding on registration petitions for medical devices previously regulated in recognized [...]

Navigating Regulatory Changes: ANVISA Extends BGMP Validity for Manufacturers under MDSAP

03/22/2024

Important Regulatory Update for Manufacturers under MDSAP in Brazil Today, ANVISA has announced a significant regulatory development with the publication of Resolution RDC 850/2024. This regulation brings forth a crucial amendment concerning the validity period of the Brazilian Good Manufacturing Practices (BGMP) Certificate for manufacturers [...]

Insights into the Practical Implications for Medical Device Clinical Investigation requirements in Brazil

01/05/2024

Collegiate Board Resolution (RDC) 837/2023, published by ANVISA on December 15th, 2023, brings updates to the rules regarding clinical investigations with medical devices performed in Brazil. Effective immediately from the publication, this resolution aligns Brazilian practices with international standards, providing clearer guidelines for [...]

Navigating the Impacts of RDC 830/2023

12/13/2023

On 11 of December 2023, ANVISA published Collegiate Board Resolution – RDC 830/2023, addressing risk classification, registration procedures, as well as labeling requirements and instructions for use of in vitro diagnostic medical devices (IVDs) in Brazil. The new RDC, effective from June 1, 2024, is a comprehensive revision that consolidates [...]

Proposed Extension of BGMP Certificate’s Validity: Navigating Regulatory Efficiency with MDSAP

11/28/2023

Public Consultation No. 1.208 will be open to receive contributions until December 9th. In the dynamic landscape of medical device regulations in Brazil, obtaining the Brazilian Good Manufacturing Practices (BGMP) certification is a mandatory request for manufacturers of Class III and Class IV devices seeking Registro. In a recent move towards [...]

New Resolution regarding medical devices’ risk classification and regularization comes into force

03/01/2023

Starting today – March 1st 2023 – the new Resolution RDC nº 751/2022 comes into force. The Resolution provides for risk classification, Notification and Registro processes, and the requirements for medical devices’ labeling and instructions for use. In order to meet the new requirements and procedures, ANVISA has already [...]

ANVISA updates the main resolution which guides medical devices’ risk classification and regularization in Brazil

09/22/2022

The Collegiate Board Resolution – RDC 751/2022 was published on the 21st of September 2022, which provides for risk classification, Notification and Registro processes, and the requirements for medical devices’ labeling and instructions for use. The new RDC consolidates the risk classification and regularization regimes for all risk [...]