ANVISA publishes RDC n °183-2017 that changes procedures for concession of Certificate of Good Manufacturing
11/15/2017
On October 19th 2017, ANVISA published RDC nº 183 which complements the provisions of RDC nº 39/2013. The new legislation amends the list of documents required for GMP application protocol, making it mandatory to submit further information on the latest inspections and audits carried out at the manufacturing plant subject to certification. [...]
See more >ANVISA Extends the Validity of Medical Device Registry to Ten Years
01/31/2018
On January 23 2018, ANVISA issued Resolution RDC 211 and RDC 212/2018, which deal with the validity period of medical device registry, as well as with the procedures related to the renewal of product registration. According to the new legislation, the registries of medical devices and IVDs (risk classes III and IV) will have a... See more >Medica Fair
10/30/2018
Domo Salute will attend Medica Fair 2018 in Düsseldorf – Alemanha from November 12th to 15th, 2018. Medica is the leading international trade fair for medical sector and it is a very attractive event: more than 5100 exhibitors from 66 nations. It will be a pleasure to meet you there if you will attend the... See more >PUBLIC CONSULTATION ANVISA – single use and reusable medical devices
01/16/2019
Some medical devices may be used more than once and be reprocessed safely. This practice gives them a longer product life and use, as long as they provide effectiveness and functionality. Medical devices that may be processed are those that allow repeated cleaning, disinfection or sterilization and that can be reused, given they comply with... [...]
See more >Medical devices now enjoy the use of electronic petition
01/23/2019
ANVISA opened on Monday (January 21thst), in the Electronic Petitioning System, the Electronic Compliance of Requirements for Medical Devices. According to the Agency, of February 25, the subject codes of secondary petitions (changes, revalidations, additions, cancellations, rectifications, among others) will also be available for electronic [...]
See more >Welcome Saúde 2019- the event that presented the political and economic perspectives for the health
01/31/2019
On January 29th, Domo Salute attended the event “Welcome Saúde 2019”, organized by Media Group to welcome the health sector this year. The event discussed the political and economic perspectives for the sector and brought experts and authorities from different links in the health chain. A survey conducted by Media Group noted that 55% of... [...]
See more >Brazil has a new Minister of Health: Luiz Henrique Mandetta
02/06/2019
Jair Bolsonaro, Brazil’s new president, began his four-year mandate on January 1st. One of the attributions of the new Brazilian leader is the structuring of his team and his ministers are the most important people in this group. The new Health Minister, Luiz Henrique Mandeta, is a doctor from Campo Grande city, Mato Grosso... See more >Arab Health 2019 in Dubai and DOMO Salute will be there
02/14/2019
Arab Health is the largest healthcare event in the MENA (Middle East and North Africa) region. More than 4,150 exhibitors from 160 countries and 84,500 visitors expected to attend Arab Health 2019 taking place from 28 – 31 January in Dubai, UAE and DOMO SALUTE will be part of it for the first time. It... See more >Class I Medical Devices Notification
03/12/2019
On March 1st, 2019, ANVISA published RDC 270 / 2019 in the Brazilian Official Gazette. The new legislation deals with the migration of the cadastro route to the notification route for Class I medical devices (materials, equipment and IVD products). RDC 270/2019 amends RDCs 36 and 40/2015 and shall enter into force as of May... See more >How were SAHE (South America Health Exhibition) and Expert Directory Event 2019
03/25/2019
DOMO Salute attended two events this month: SAHE (South America Health Exhibition) and Expert Directory Event 2019, promoted by Swiss Business Hub Brasil. SAHE, which took place from March 12th to March 14th, held more than twenty forums, gathering over 400 speakers throughout the three-day schedule, thus offering around 400 hours of content [...]
See more >What about INMETRO
03/28/2019
A significant number of manufacturers that look for our regulatory services are not just searching for ANVISA registration services, their doubts are related to INMETRO certification processes and their requirements, which many times are not thoroughly discussed when planning a regulatory strategy for medical devices’ registration in Brazil. [...]
See more >Domo Salute at the 26th edition of Hospitalar Trade Fair
06/05/2019
For the third consecutive year, Domo Salute has participated in the most relevant Latin American showcase in the health sector: Hospitalar Trade Fair. At Rio Grande do Sul’s collective stand, which was organized by Sebrae RS, Health Technology Cluster and the State Government, companies had the opportunity to advertise their products and [...]
See more >BRAZIL’s INMETRO proposing new model
07/19/2019
INMETRO has issued a public consultation regarding the proposal for what they are calling a “New regulatory model for INMETRO”. The main goal, according to INMETRO’s director Gustavo Kuster, is to make Brazilian market safer for society and citizens and to create a less bureaucratic and more simple system. The action is a part of... See more >ANVISA`s Regulatory guillotine
07/30/2019
In 2014, ANVISA created a management model for its regulatory stock based on the organization of thecurrent rules, monitoring their effectiveness and generating inputs for their review. The goal was, and still is, to make the stock more efficient, rational, clear and understandable. According to civil servant Raianne Liberal Coutinho, the [...]
See more >Brazilian Regulatory System – News Roundup
08/16/2019
Our team has compiled a few important news from the past days concerning medical device’s regulation and the Brazilian regulatory system: Field safety correction action information is now submitted to ANVISA by electronic system Since the 22th of July manufacturers must submit field safety correction action information via ANVISA’s electronic [...]
See more >ANVISA’s performance report: An analysis on medical device and IVD registration
08/23/2019
ANVISA has published the second trimestral GGTPS (Medical Device Technology General Management) performance report. The report presents data, results and metrics concerning the first two trimesters of 2019. The first report, published ion April, can be found on ANVISA’s website. According to Leandro Rodrigues Pereira, General Manager of the [...]
See more >ANVISA’s special report: 2018 results
09/05/2019
ANVISA publishes 2018 management results Brazilian medical device market regulator ANVISA recently published the annual Management Report concerning 2018’s results. According to Willian Dib, ANVISA’s CEO, presenting the annual report to the society reaffirms the Agency’s commitment and transparency. DOMO’s Team has evaluated the report and [...]
See more >Contacting Brazilian Regulatory Agencies – ANVISA, INMETRO e ANATEL
09/20/2019
ANVISA recently opened a new communication channel and our team prepared an update on all the available resources for contacting Brazilian key Regulatory Agencies, concerning medical devices. Knowing how to reach out to the agencies can help if you intend on entering the Brazilian Market. ANVISA Central de Atendimento / Call Center The phone [...]
See more >ANVISA publishes new rules for custom-made devices
09/30/2019
Brazilian medical device market regulator ANVISA published on September 24th new rules for manufacturing, importing, marketing and vigilance responsibilities concerning custom-made devices. Under ANVISA’s current system, custom-made devices’ applications had to go through a specialized submission process, with no specific Brazilian regulations [...]
See more >ANVISA’s Digital Plan
10/17/2019
ANVISA, the Ministry of Economy and the Presidency approved, on Wednesday (9/10), the Agency’s Digital Plan. As a part of the strategy to implement the Executive Power’s Digital Governance Policy, the program wishes to transform 120 ANVISA services to digital by the end of 2020. Throughout 2019 we have had significant progress [...]
See more >Brazilian Regulatory System – News Roundup
10/24/2019
Our team has compiled a few important news from the past days concerning medical device’s regulation and the Brazilian regulatory system: ANATEL – New regulation for Conformity Assessment and Homologation of Telecommunication Products ANATEL approved on October 17th, the new Regulations for Conformity Assessment and Homologation of [...]
See more >Meet our team at MEDICA 2019
10/29/2019
We are proud to participate once again the world’s largest event for the medical sector – MEDICA 2019 – from November 18th to November 21st in Düsseldorf, Germany. We’ll be at MEDICA 2019 to talk about how we’re helping medical device companies bring to market new products to Brazil, and discuss the key areas of... See more >ANVISA’s Public Consultation nº 730/2019 and 734/2019
12/06/2019
Updates regarding Definitions, Classification, Registration Pathways, Labeling and Instructions for Use requirements for Medical Devices and IVD Medical Devices ANVISA has opened in last October the Public Consultation 730/2019 to discuss with the community updating RDC 185/2001, the standard that drives medical device [...]
See more >Normative Instruction 49/2019 updates list of Technical Standards for medical device compliance certification
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 (22nd November 2019). It is important to highlight that Normative Instructions No. 4 (September [...]
See more >ANVISA publishes IMDRF Guides for medical devices’ Clinical Evaluation
01/16/2020
ANVISA published last December three Guides from the International Medical Device Regulators Forum (IMDRF), related to the scenario of clinical evaluation of medical devices in Brazil. The Guides express ANVISA’s understanding of best practices regarding procedures, routines and methods deemed appropriate to meet technical or [...]
See more >ANVISA’s upcoming regulation on SaMD’s – Software as Medical Device –
02/14/2020
ANVISA published in January the SaMD Regulatory Impact Analysis Report regarding important information for the safe and effective use of medical softwares as well as the sanitary actions associated with these products . According to the Agency, traditional regulations for medical devices have a gap, as they do not cover specific aspects for [...]
See more >Using the MDSAP Program to enter the Brazilian Market
02/20/2020
The Medical Device Single Audit Program (MDSAP) is a program developed by IMDRF (International Medical Device Regulators Forum) that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing [...]
See more >Foreign participation in Brazilian public tenders becomes more simple
02/28/2020
Published on Tuesday (11) in the Federal Official Gazette, Normative Instruction 10 from the Ministry of Economy reduced the barriers to the presence of external companies in federal bids. The new rules will take effect on May 11, 2020. According to the Normative Instruction, foreign companies must open a National Corporate Taxpayer Registry [...]
See more >ANVISA’S measures on medical devices during the Covid-19 Pandemic
03/17/2020
Covid-19: Prioritizing IVD products Last Thursday (03/12/2020) ANVISA published an update regarding IVD products for Covid-19 diagnosis aiming to speed products regularization and the offer of diagnostics. ANVISA will prioritize the analysis of all processes related to products for Covid-19 diagnosis and other agents that cause respiratory [...]
See more >Temporary procedures for personal protective equipments, pulmonary ventilators and strategic medical devices regularization in Brazil announced to fight the new Coronavirus
03/21/2020
ANVISA published yesterday RDC 349/2020 regarding temporary procedures for requests for the regularization of personal protective equipments, pulmonary ventilator medical equipments and other medical devices identified as strategic by ANVISA due to the international public health emergency resulting from the new Coronavirus. Our team prepared [...]
See more >New temporary procedures for the manufacture, import and acquisition of strategic medical devices announced to fight the new Coronavirus
03/24/2020
ANVISA published RDC 356/2020 regarding extraordinary and temporary procedures on the requirements for the manufacture, import and acquisition of medical devices identified as priorities by ANVISA due to the international public health emergency resulting from the new Coronavirus. Our team prepared a few highlights with important changes: * [...]
See more >INMETRO’s temporary procedures facing the new Coronavirus
04/07/2020
Updated on July 2nd 2020: INMETRO published, on the 30th of June, Ordinance nº 225 which extended the terms and temporary procedures for Conformity Assessments, due to the international public health emergency resulting from the new Coronavirus. The Ordinance extends the possibility of remote audits until December 31st 2020, as well as [...]
See more >Brazilian Regulatory Agencies & Covid-19
04/28/2020
In response to the COVID-19 outbreak, Brazilian regulatory agencies (ANVISA & INMETRO), as well as many other regulators around the world, have released in the past month Ordinances and Resolutions regarding emergency and temporary procedures for medical devices that are strategic to fight against the pandemic. The regulations include new [...]
See more >Are Remote Audits an option when accessing the Brazilian medical device market?
05/22/2020
Medical device manufacturers are providing life-saving equipment to care for patients who have been infected with the new coronavirus. But how do you conduct a third-party audit, required for market access, when most of us must work remotely? How the Brazilian Regulatory Agencies such as ANVISA and INMETRO are dealing with this? Remote [...]
See more >ANVISA’s special report: 2019 results
07/10/2020
ANVISA has made available on their website the annual Management Report, concerning 2019’s results and the governance of the Agency. The report aims to make available to the society general data and specific information from technical departments. The report shows that the Agency has achieved good results and an increasing number of medical [...]
See more >ANVISA: Alterations on your regularized medical device
07/23/2020
From April this year, ANVISA implemented new rules for the classification of petitions for the alteration of medical devices. According to ANVISA, the measures, ruled by RDC 340/2020 and IN 61/2020, aim to define different categories for alterations on medical devices based on their risk, making clear which changes have to be previously [...]
See more >RDC Nº 346/2020 validity extended
09/04/2020
ANVISA published yesterday (September 3rd) RDC 419/2020 extending the validity of the RDC 346/2020 which defines extraordinary and temporary criteria and procedures for GMP Certification, for registration purposes and post-registration changes to active pharmaceutical ingredients, medicines and medical devices, due to the international public [...]
See more >Covid-19 Post market surveillance
09/14/2020
In tackling the Covid-19 pandemic ANVISA has been focusing on the transparency of data, and recently made available for consultation, through Business Intelligence (BI) platforms, the results from monitoring Covid-19 related products and diagnostic tests. One of the platforms is the Post-Market Monitoring of the quality of Covid-19 related [...]
See more >ANVISA publishes RDC 423/2020 extinguishing the CADASTRO route
09/18/2020
ANVISA published today (September 18th) the Resolution 423/2020 which establishes that Risk Class II medical devices that were previously under the CADASTRO regime, will be now taking the NOTIFICATION route. Last year (March 1st) ANVISA had established the NOTIFICATION route for Risk Class I devices through RDC 270/2019. Under the new [...]
See more >ANVISA adds 33 products to the list of exempted healthcare products
10/22/2020
ANVISA published, on the 9th of October, Technical Note nº 218/2020 updating the list of products that are exempt from regulation by the Agency. Some of these products were included in the list of low risk health products (class I) subject to registration. However, considering that they did not fit the definition of medical devices... See more >INMETRO’s new Ordinance 384/2020 has brought new alternatives for conformity assessment
02/17/2021
At the end of 2020 INMETRO published Ordinance 384, which came into force on December 28th. The new regulation replaces Ordinance 54/2016 with new requirements for conformity assessment for equipment under health surveillance, establishing more clearly the competence of Certfication Bodies and ANVISA. Amongst the main changes, we highlight: [...]
See more >New temporary procedures to import medical devices announced to fight the new Coronavirus
03/23/2021
ANVISA published last friday (March 19th) RDC Nº 483/2021, which defines extraordinary and temporary requirements for the import of medical devices identified as priority by ANVISA due to the international public health emergency resulting from the new Coronavirus. Under the terms of the new Resolution, medical devices listed in Annex I of the [...]
See more >ANVISA: the advances of 2020 in regulatory quality improvement
03/31/2021
The Brazilian Health Regulatory Agency – ANVISA – released on March 5th the report Regulation in Numbers, presenting the 2020 actions aiming to improve the regulatory quality of the Agency. The report summarizes the main activities of the year, such as general and normative publications, regulatory projects, community participation [...]
See more >New General Product Certification Requirements – INMETRO
06/01/2021
On June 1st 2021 the new RGCP (General Product Certification Requirements) came into effect, as established by INMETRO Ordinance No. 200 (April 29th, 2021). The new requirements are a part of INMETRO’s project to reduce the certification processes’ bureaucracy in the Brazilian market, and revoked previous Ordinances numbers 118-2015, 250-2016; [...]
See more >ANVISA – 25 RDCs and 1 IN come into force
10/04/2021
25 Collegiate Board Resolutions (RDCs) and one Normative Instruction (IN) that were published by ANVISA on 08/31/2021 came into force on October 1st, 2021. The publications are part of the 4th stage of the review and consolidation process of the Agency’s normative acts, in compliance with Decree 10,139 / 2019 – known as the [...]
See more >Stay tuned!
10/08/2021
The deadline for uploading the medical devices’ instructions for use on ANVISA’s portal ends at the end of this month. Resolution RDC No. 431/2020, which came into force on November 1st 2020, granted a period of 1 year to make registered devices’ instructions for use available, for products which were approved by ANVISA before the... See more >medical devices’ import processes by RDC 483/2021 are extinct
11/29/2021
– all import processes must comply with RDC 81/2008 On the 18th of November ANVISA informed that Resolution RDC 483/2021 was not extended. The Resolution, originally published in March this year, defined extraordinary and temporary requirements for the import of medical devices identified as priority by ANVISA due to the international [...]
See more >Regulation for Unique Device Identification (UDI) comes into force in Brazil
01/20/2022
On January 10th 2022, the regulation that provides for the identification of medical devices regularized by ANVISA through the Unique Device Identification (UDI) system – RDC 591/2021 came into force. The Unique Devices Identification is an international standard that complies with the International Medical Device Regulators Forum’s [...]
See more >BRAZILIAN AGENCY ANVISA APPROVES USE OF COVID-19 SELF-TEST
02/03/2022
Throughout RDC 595/2022, ANVISA has established on the 28th of January the requirements for SARS-CoV-2 antigen self-test’s registration, distribution, commercialization and usage. The Resolution allows pharmacies and other healthcare companies to sell COVID-19 self-test kits directly to the population. Here are a few highlights on the [...]
See more >ANVISA publishes Resolution for Software as a Medical Device – SaMD’s Regularization
04/08/2022
Aiming to keep up with the scientific and technological advances and meet new demands from the health care sector, ANVISA published – on the 30th of March 2022 – RDC 657/2022 which provides for the regularization of Software as a Medical Device (SaMD). The Resolution will come into force on the 1st of July 2022.... See more >Brazilian Health Regulatory Agency updates Good Manufacturing Practices for medical devices and IVDs
04/28/2022
Completing the process of reviewing and consolidating normative acts that allowed improvements in the wording and form of normative acts and the exclusion of obsolete provisions, ANVISA published on March 30th 2022, in the Brazilian Official Gazette (D.O.U., in Portuguese), RDC No. 665/2022, which provides for Good Manufacturing Practices [...]
See more >ANVISA updates the resolution for Brazilian Good Manufacturing Practices Certification granting and renewal
06/22/2022
Resolution RDC 687/2022 was published on May 18th in the Federal Official Gazette. The new resolution provides for the criteria for granting or renewing the Brazilian Good Manufacturing Practices Certification for medical devices, and came into force on June 1st 2022, revoking RDC 183/2017. RDC 687/2022 applies to risk class III and IV medical [...]
See more >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 [...]
See more >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 [...]
See more >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 [...]
See more >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 [...]
See more >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 [...]
See more >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 [...]
See more >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 [...]
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