LATEST NEWS

Brazilian Regulatory System – News Roundup

Date: 11/10/2019

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 Telecommunications Products.

 

The new Regulation institutes the end of fee charges for the homologation certificate’s issuance. The exemption from the fee is immediate and valid for all telecommunications products approved by ANATEL.

 

In the conformity assessment process, the equipment is subjected to verification of technical standards and laboratory tests that seek to ensure that they are properly tested and approved for use in Brazil.

 

The Regulations to which it refers shall enter into force within 180 days from the date of publication of the Resolution in the DOU (Brazilian Official Gazzete), except in relation to the obligations contained in Title IV and art. 58, concerning, respectively, the Market Surveillance Program and the exemption from the fees, which will enter into force on the date of publication of the new Resolution.

 

The changes, comparing it to the current regulation, concern the gratuity of the Homologation Fee, the Market Supervision Program, with the collection of samples made by the OCDs or ANATEL, and Certificates of Technical Compliance that will be issued only considering the applicant established regularly in the country.

 

Also, the Market Surveillance Program – where OCDS will collect samples directly from the market, according to procedure to be defined by ANATEL, came into effect with the publication. OCDs may also have Memorandum of Understanding with foreign Certification Bodies, as long as they are accredited by an accrediting Body recognized by INMETRO / ANATEL.

 

Petition Analysis Cycle Panel – ANVISA’s new online tool 

 

ANVISA has recently made available on its website the Petition Analysis Cycle Panel, a tool that shows all the steps of the petition process, from the entry in the analysis queue to the moment the registrations and authorizations are finalized.

 

The purpose is to present, at various levels of analysis, the main stages and life cycle times of petition analysis.  With the aid of the new instrument, companies now have the opportunity to know the average and median deadlines for the granting of product registration and Business Operation Authorizations (AFEs).

 

ANVISA’s Webinar 

 

ANVISA periodically hosts a Webinar – virtual seminars that bring updated content and knowledge to the public. This week, the Webinar addressed medical equipment’s registration main technical requirements. In addition, ANVISA presented the main reasons for medical equipment’s registration refusal and notification’s cancellation.

 

The purpose of the seminar was to explain the process of regularization of risk class I and II equipments according to Collegiate Board Resolution (RDC) 270/2019, RDC 40/2015 and Normative Instruction (IN) 22/2017, among other norms and understandings on the subject.

 

The recording of the seminar and comments made during the transmission are available in portuguese.

 

“20 years of Medical Device Regulation at Anvisa ANVISA – next steps”

 

Registration is now open for participation in the Regulatory Dialogue “20 years of Medical Device Regulation at ANVISAnvisa – next steps”. The activity will be held next November 6, in Brasilia. The program of the event includes the discussion of topics such as advances and regulatory perspectives in the country, highlighting the challenges related to custom-made medical devices, software and product’s cybersecurity.

 

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

 

DOMO Salute Team

 

Ronda regulatória DOMO Salute

 

Nossa equipe  preparou um resumo das principais notícias recentes referentes à área regulatória de produtos para saúde no Brasil. Confira abaixo:

 

Nova Resolução ANATEL

 

O Conselho Diretor da Agência Nacional de Telecomunicações (AnatelANATEL) aprovou nesta última quinta-feira, 17 de outubro, o novo Regulamento de Avaliação da Conformidade e de Homologação de Produtos para Telecomunicações.

 

O novo Regulamento traz o fim de cobranças para a expedição do certificado de homologação. A isenção da taxa é imediata e válida para todos os produtos de telecomunicações homologados pela ANATEL.

 

No processo de avaliação da conformidade, os equipamentos são submetidos à verificação de padrões técnicos e ensaios laboratoriais que buscam garantir que eles sejam devidamente testados e aprovados para uso no Brasil.

 

O Regulamento entrará em vigor no prazo de 180 (cento e oitenta) dias a contar da data da publicação da Resolução no DOU, exceto em relação às obrigações contidas no Título IV e art. 58, referentes, respectivamente, ao programa de supervisão de mercado e à isenção dos emolumentos de homologação, que entrarão em vigor na data da publicação da nova Resolução.

 

Para os requerentes, as mudanças são somente a gratuidade da Taxa de Homologação, o Programa de Supervisão de Mercado – com coleta de amostras feitas pelo OCDs ou pela ANATEL – e os Certificados de Conformidade Técnica – que serão emitidos somente considerando solicitante estabelecido regularmente no país.

 

Passa a existir o Programa de Supervisão de Mercado, onde os OCDs farão a coleta das amostras diretamente no mercado, conforme procedimento à ser definido pela ANATEL. Os OCDs também poderão ter Memorando de Entendimento com Organismos de Certificação estrangeiros, desde que acreditados por Organismo acreditador reconhecido pelo INMETRO/ANATEL.

 

Além disso, a regulamentação aprovada torna os procedimentos e os modelos de avaliação mais céleres e versáteis, o que simplifica e desburocratiza o processo de avaliação da conformidade, mantendo a exigência de elevados padrões de qualidade e segurança para o consumidor.

 

Painel do Ciclo de Análise de Petições – ANVISA

 

A ANVISA disponibilizou em seu portal o Painel do Ciclo de Análise de Petições, uma ferramenta que mostra todas as etapas de um processo de petição, desde a entrada na fila de análise até o momento em que os registros e as autorizações são finalizados.

 

Seu objetivo é apresentar, em diversos níveis de análise, os principais estágios e os tempos do ciclo de vida da análise de petições.  Com a disponibilização desse instrumento, a sociedade tem a oportunidade de conhecer, via web, os prazos médios e medianos para a concessão de registro de produtos e de Autorizações de Funcionamento de Empresas (AFEs).

 

Webinar ANVISA – exigências para cadastro de equipamento médico

A ANVISA realiza periodicamente Webinars – seminários virtuais que tem como objetivo fortalecer as iniciativas de transparência da AnvisaANVISA, levando conteúdo e conhecimento atualizado ao público.  O último Webinar, realizado no dia 24, abordou as principais exigências técnicas para o cadastro de equipamentos médicos, além de esclarecer aos participantes os principais motivos de indeferimento do cadastro e de cancelamento da notificação desses equipamentos.

 

O objetivo do seminário é explicar o processo de regularização dos dispositivos de classe de risco I e II previsto na Resolução da Diretoria Colegiada (RDC) 270/2019, na RDC 40/2015 e na Instrução Normativa (IN) 22/2017, entre outras normas e entendimentos sobre o tema.

 

A gravação do Webinar, bem como os comentários e dúvidas registrados no chat durante o seminário, está disponível no site da ANVISA.

 

Diálogo Regulatório sobre os “20 anos de Regulação de Dispositivos Médicos na ANVISA – próximos passos”

 

Estão abertas as inscrições para participação no Diálogo Regulatório sobre os “20 anos de Regulação de Dispositivos Médicos na Anvisa ANVISA – próximos passos”. A atividade será realizada no próximo dia 6 de novembro, em Brasília.  A programação do evento inclui o debate de temas como os avanços e as perspectivas regulatórias no país, com destaque para os desafios relacionados aos dispositivos médicos personalizados, softwares e cibersegurança dos produtos.

 

Siga nossas redes sociais e acompanhe as principais notícias referentes ao sistema regulatório brasileiro. 

 

Equipe DOMO Salute

 

Links:

 

http://portal.anvisa.gov.br/noticias?p_p_id=101_INSTANCE_FXrpx9qY7FbU&p_p_col_id=column-2&p_p_col_pos=1&p_p_col_count=2&_101_INSTANCE_FXrpx9qY7FbU_groupId=219201&_101_INSTANCE_FXrpx9qY7FbU_urlTitle=aberta-inscricao-para-evento-sobre-dispositivos-medicos&_101_INSTANCE_FXrpx9qY7FbU_struts_action=/asset_publisher/view_content&_101_INSTANCE_FXrpx9qY7FbU_assetEntryId=5667420&_101_INSTANCE_FXrpx9qY7FbU_type=content

 

http://portal.anvisa.gov.br/noticias/-/asset_publisher/FXrpx9qY7FbU/content/webinar-exigencias-para-cadastro-de-equipamento-medico/219201?p_p_auth=G3JeC9Xm&inheritRedirect=false&redirect=http://portal.anvisa.gov.br/noticias%3Fp_p_auth%3DG3JeC9Xm%26p_p_id%3D101_INSTANCE_FXrpx9qY7FbU%26p_p_lifecycle%3D0%26p_p_state%3Dnormal%26p_p_mode%3Dview%26p_p_col_id%3D_118_INSTANCE_KzfwbqagUNdE__column-2%26p_p_col_count%3D2

 

https://www.anatel.gov.br/institucional/component/content/article/171-manchete/2416-anatel-aprova-novo-regulamento-de-avaliacao-da-conformidade-e-de-homologacao-de-produtos

 

http://portal.anvisa.gov.br/noticias/-/asset_publisher/FXrpx9qY7FbU/content/ferramenta-torna-acessivel-ciclo-da-analise-de-peticoes-/219201?p_p_auth=RmFx71Ih&inheritRedirect=false&redirect=http%3A%2F%2Fportal.anvisa.gov.br%2Fnoticias%3Fp_p_auth%3DRmFx71Ih%26p_p_id%3D101_INSTANCE_FXrpx9qY7FbU%26p_p_lifecycle%3D0%26p_p_state%3Dnormal%26p_p_mode%3Dview%26p_p_col_id%3D_118_INSTANCE_KzfwbqagUNdE__column-1%26p_p_col_count%3D1

MORE NEWS

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 the 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 ”(link event) 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 [...]
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
Link para o vídeo: https://youtu.be/PicwqlhAELI 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...
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 [...]
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 [...]
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 [...]
See more >
Brazilian Regulatory System – News Roundup
10/25/2019
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 [...]
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 >
BRAZIL’s INMETRO proposing new model
11/10/2019
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 >
Brazilian Regulatory System – News Roundup
11/10/2019
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 [...]
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 >