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ANVISA’s special report: 2018 results

Date: 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 summarized the highlights and key results achieved by the agency regarding medical device:

Almost 16 new registrations per day

The management report highlights that 5.780 new medical device were approved in 2018, composed by 1.106 Registro (products classified as Risk Class III and IV) and 4.674 Cadastro (products classified as Risk Class I* e II). The amount of products being registered in 2018 corresponds to almost 16 new medical device per day. The numbers also represent new registrations increasing 11,4% in the past 3 years (2016 to 2018).

*Before May 2019, products classified as Risk Class I had to comply with the Cadastro route. Since then, a new path has been created, and Risk Class I products are now regularized by Notification. Learn more from our post about Notification. https://www.domosalute.com.br/blog-1/new-regularization-for-class-i-medical-devices-notification

Brazilian Good Manufacturing Practice Certification – 513 granted to foreign manufacturers

Manufacturers of Risk Class III and IV medical devices must be in compliance with the Brazilian Good Manufacturing Practice (BGMP). During 2018, 99 on-site audits were performed abroad in order to achieve the certification. Also, 513 BGMP certification were granted to foreign manufacturers (new certification and renewals), while 13 applications were rejected.

Technovigilance

Technovigilance is designed to ensure that approved medical devices function in accordance by early detecting problems related to use, and promoting measures to eliminate or minimize the risks. Adverse incidents must be reported in case of malfunction and inadequate labeling, for example.

ANVISA received 13.227 formal complaints through the system NOTIVISA. The majority (93,7%) were related to medical device, whilst 4,7% were related to medical equipment and 1,6% to IVD products.

The majority of adverse events reported to ANVISA were also related to medical device (73,7%), and 26,3% related to medical equipment.

Regulatory stock management 

Managing the regulatory stock means organizing the current rules, monitoring their effectiveness and generating inputs for their review. The main goal is making the stock more efficient, rational, clear and understandable. ANVISA has been working towards a more effective regulatory stock management since 2014, and has achieved significant results in 2018. Check our post about ANVISA’s Regulatory Guillotine to learn more. https://www.domosalute.com.br/blog-1/anvisa-s-regulatory-guillotine

Economic Studies and Regulatory Intelligence

Since May 2018 a health product pricing panel is available for consultation on ANVISA’s website. The pricing panel gathers information on more than 5,000 model-products. The data is available for consultation by business name, product model, registration number, among others.

In addition to the basic information, the price to be practiced in the domestic market and prices in other countries are also available. The information is consolidated in an interactive panel provided by ANVISA on their website. https://app.powerbi.com/view?r=eyJrIjoiNDNlOTZlMjctMDA3NS00MzBjLWFlYmEtMDBiNTBjYjA4MWRmIiwidCI6ImI2N2FmMjNmLWMzZjMtNGQzNS04MGM3LWI3MDg1ZjVlZGQ4MSJ9

 

Click here to download 2018 Management Report (Portuguese only). http://portal.anvisa.gov.br/documents/281258/2941545/Relat%C3%B3rio+de+Gest%C3%A3o+Anvisa+2018/08bada09-d3a3-47b7-80fb-ebe08f7fae3e

Click here to check ANVISA’s Management Report summary folder 2018 (English). http://portal.anvisa.gov.br/documents/281258/2941545/Inglês+-+Folder+s%C3%ADntese+-+Relatório+de+Gestão+2018/bd61eda0-a7b8-4b4b-8e89-7bc7cdb3b327

 

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

 

DOMO Salute Team

 

ANVISA divulga relatório de gestão de 2018

Relatório de gestão: ANVISA divulga resultados alcançados em 2018

Está disponível no website da ANVISA o Relatório de Gestão 2018, que traz um consolidado dos resultados obtidos, além de apresentar dados de governança da Agência. O objetivo do relatório é divulgar as informações gerais e das diversas áreas técnicas que compõem a instituição.

O diretor-presidente da Agência, Willian Dib, reforçou, em uma carta aberta publicada no Relatório de Gestão 2018, que, em 20 anos de atuação, a instituição vem atuando no controle sanitário da produção, na comercialização e no uso de produtos e de serviços submetidos à vigilância sanitária, além de trabalhar pela modernização da regulação sanitária.

Ele destacou também o trabalho baseado em conhecimento técnico, atuação ética e a responsabilidade na gestão dos recursos públicos. “A Agência é uma das protagonistas na proteção e na promoção da saúde da sociedade brasileira, cumprindo, assim, a sua missão. A Diretoria da ANVISA vem reafirmando seu compromisso com um conjunto de valores que, nestas duas décadas, nunca deixou de nortear suas atividades”, afirma Willian Dib. Segundo ele, a apresentação do relatório anual de gestão reforça o comprometimento e transparência da Agência.

A equipe DOMO Salute avaliou o relatório e apresenta os principais resultados da Agência na área de produtos para a saúde, confira:

Registro de produtos

O Relatório de Gestão destaca a regularização de 5.780 novos dispositivos médicos, sendo 1.106 registros (produtos de maior classe de risco pertencentes às classes de risco III e IV) e 4.674 cadastros* (produtos de menor risco pertencentes às classes de risco I e II). O montante de novos produtos regularizados correspondeu à regularização de quase 16 por dia. Além do grande volume de aprovações concedidas, o número também representou um crescimento de 11,4% em três anos (2016-2018).

*Em 2018 produtos das classes I e II estavam sujeitos ao regime de cadastro. A partir de maio de 2019, a regularização de dispositivos classe I passou a ser através do processo de Notificação. Para saber mais, acesse o post sobre Notificação. https://www.domosalute.com.br/blog-1/notifica%C3%A7%C3%A3o-de-dispositivos-m%C3%A9dicos-de-classe-i

Certificação de Boas Práticas de Fabricação

A ANVISA realiza inspeções técnicas para assegurar as Boas Práticas de Fabricação (BPF) em fabricantes de produtos de maior classe de risco (III e IV). 99 inspeções para fins de verificação de BPF foram realizadas em território estrangeiro. Durante o período, um total de 513 Certificações de Boas Práticas de Fabricação (CBPF) em território estrangeiro foram deferidas, enquanto 13 tiveram sua solicitação indeferida.

Tecnovigilância

A vigilância de eventos adversos (reações nocivas à saúde, que ocorrem sob condições normais de uso, abuso ou mau uso) e de queixas técnicas (notificações de suspeita de alteração ou irregularidade de um produto ou empresa em aspectos técnicos ou legais) no pós-uso, ou pós-comercialização, tem como objetivo fundamental a detecção precoce de problemas relativos ao uso, visando desencadear as medidas para que o risco seja eliminado ou minimizado.

Um total de 13.227 queixas técnicas foram recebidas pela ANVISA através do sistema NOTIVISA. Destas, a maior parte (93,7%) refere-se a materiais de uso médico, enquanto 4,7% está relacionada a equipamentos médicos e 1,6% a produtos para diagnóstico in vitro.

Entre as 3.945 notificações de eventos adversos recebidas, a maioria também estava relacionada a artigos médicos (73,7%), e 26,3% a equipamentos médicos.

Gestão do estoque regulatório

A gestão do estoque regulatório é um processo dinâmico e sistemático de organização, acompanhamento e revisão dos atos normativos, para promover o acesso qualificado ao marco regulatório e avaliar sua adequação, visando à melhoria da qualidade regulatória e, dessa forma, contribuindo para promoção e proteção da saúde da população. Esse processo, que vem avançando na ANVISA desde 2014, alcançou resultados significativos durante o ano de 2018. Veja nossa postagem sobre esse tema. (linkar post da guilhotina regulatória)

Estudos econômicos e de Inteligência Regulatória

Desde maio de 2018, a ANVISA conta em seu website com um painel de preços de produtos para saúde, que reúne informações sobre mais de 5 mil produtos-modelo. No painel são permitidas consultas por nome comercial, modelo do produto, número do registro, entre outras. Além das informações básicas, estão disponíveis, ainda, o preço que se pretende praticar no mercado nacional e os preços em outros países. Essas informações estão consolidadas em um painel interativo disponibilizado pela Anvisa no seu portal eletrônico (http://portal.anvisa.gov.br/ pesquisa-de-precos). https://app.powerbi.com/view?r=eyJrIjoiNDNlOTZlMjctMDA3NS00MzBjLWFlYmEtMDBiNTBjYjA4MWRmIiwidCI6ImI2N2FmMjNmLWMzZjMtNGQzNS04MGM3LWI3MDg1ZjVlZGQ4MSJ9

Acesse aqui o Relatório de gestão 2018 (em Português).

http://portal.anvisa.gov.br/documents/281258/2941545/Relat%C3%B3rio+de+Gest%C3%A3o+Anvisa+2018/08bada09-d3a3-47b7-80fb-ebe08f7fae3e

Está disponível, também, um folder síntese elaborado pela ANVISA (versões em inglês e português).

http://portal.anvisa.gov.br/relatorios-de-gestao1

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

Equipe DOMO Salute

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