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ANVISA’s performance report: An analysis on medical device and IVD registration

Date: 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 GGTPS, the performance report is a management tool that attends to the Agency’s duty and commitment on being transparent and providing useful data to society and the industry. It also serves the purpose of monitoring the medical device sector’s services demands.

Check below DOMO Salute’s team analysis on the report and GGTPS’ more important results ion 2019:

Petition balance positive in 2019

The petition balance is calculated by taking into consideration the number of petitions completed (outcomes) and the number of petitions filed (incomes) at a set period of time. It is interesting to observe that the number of petitions waiting to be analyzed and/or under analysis, during the second trimester is lower comparing to the first trimester of 2019. The balance now is positive with 10.425 being the number of petitions entering GGTPS for analysis (incomes) and 11.823 the number of petitions completed (outcomes) in 2019.

The new regulatory path for lower risk products (Notification) is certainly one of the responsible for the better results achieved. Notification is a simple registration path for Class Risk I medical device, that came into effect on May 2019, and doesn’t require technical evaluation from the Agency. The measure has clearly impact positively on the balance.

Rejection rates are lowest since 2018

Rejection rates for the second trimester were 8,2%, the lowest since the beginning of 2018. Comparing to the first trimester of the year, the rejection rate is significantly lower, especially if we look at Registro submissions (Class risk III and IV) and secondary petitions.

ANVISA believes the good results are a reflection of a series of webinars that have been available at the Agency’s website as they might have helped companies to better understand the requirements, therefore reducing rejection rates.

Timeframe averages 

Regarding the timeframe to get ANVISA’s first response (being the approval issue or additional requirements) the average for the second trimester was 31.82 days – the lowest since the beginning of 2018. Certainly the good performance is also reflecting the advent of Notification path – which takes an average of 10 to 20 days to be issued by ANVISA.

Considering only the timeframe to get ANVISA to publish the approval (not their first response) – it rises up to 74.90 days. There’s been a small increase on the timeframe to issue Cadastro (Risk Class II) and Registro’s approval comparing to last year, but 2019 numbers are still satisfactory considering ANVISA’s performance throughout the years. The average is expected to decrease during the next semester due to Notification process reducing the workload and allowing ANVISA’s evaluators to focus on Cadastro and Registro petitions.

Taking a closer look on the different divisions’ performances (GEMAT – the division responsible for materials, GQUIP – division responsible for equipment and GEVIT – division responsible for IVDs) we can see that they share the same tendencies, which demonstrates they are working consistently and towards the same goals.

The performance report also presents a few highlights from the trimester such as:

  • National and International Regulatory events with ANVISA’s participation;
  • Important regulatory publications such as the Notification process and the public consultation on custom made devices.

To download the second trimester performance report for 2019, check ANVISA’s website.

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

 

DOMO Salute Team

 

Resultados e Indicadores da GGTPS/ ANVISA em 2019: Uma análise dos Relatórios de Produtividade

No último dia 25 de julho, a ANVISA divulgou o segundo Relatório Trimestral de Produtividade da GGTPS (Gerência Geral de Tecnologia de Produtos para Saúde) de 2019. O documento apresenta os resultados e principais indicadores de desempenho da GGTPS neste ano, reunindo os dados dos dois primeiros trimestres. O primeiro Relatório de Produtividade foi publicado em abril e encontra-se disponível para download no website da Agência (http://portal.anvisa.gov.br/documents/33912/264658/Relat%C3%B3rio+Trimestral+de+Produtividade+GGTPS+-+1%C2%BA+Trimestre+de+2019/e4a43912-170c-4b2a-a237-65866f6db839).

De acordo com o Gerente Geral da GGTPS, Leandro Rodrigues Pereira, o Relatório de Produtividade é uma ferramenta de gestão que atende ao dever e compromisso de transparência da ANVISA com a sociedade civil e o setor regulado, contendo dados e informações úteis aos usuários, além de servir como instrumento de acompanhamento da demanda de atendimentos da área de dispositivos médicos.

A equipe da DOMO Salute avaliou o Relatório e apresenta aqui os principais resultados de produtividade da GGTPS em 2019.

Saldo de Petições é positivo em 2019

O saldo de petições é calculado levando-se em consideração o número de petições analisadas integralmente (saída) e petições protocoladas (entrada) no mesmo intervalo de tempo. É interessante observar que o estoque de petições aguardando análise ou sendo analisadas no 2º trimestre de 2019 é menor do que o mesmo período do ano anterior. Além disso, é notável a melhoria do saldo acumulado no 2º trimestre de 2019 quando comparado com o saldo acumulado no 1º trimestre deste ano. O saldo atual de petições é positivo, sendo 10.425 o número de entrada de processos na GGTPS em 2019 e 11.823 o número de saída.

O novo regime de regularização para produtos de menor risco foi certamente um dos responsáveis pelo aprimoramento dos resultados. A Notificação trata-se de um modelo simplificado de regularização de dispositivos médicos classe I que entrou em vigor em maio deste ano e que não exige análise técnica prévia das petições. Dessa forma, é evidente que esta iniciativa da Agência causou um impacto positivo no saldo de petições concluídas.

Indeferimentos – menor taxa desde 2018

O percentual de indeferimento no 2º trimestre de 2019 é de 8,2%, o mais baixo em todos os trimestres desde o início de 2018. Quando comparado ao primeiro trimestre deste ano, a quantidade de indeferimentos é significativamente menor, principalmente se considerarmos pedidos de registro (classes de risco III e IV) e petições secundárias.

A ANVISA acredita que a melhora dos resultados possa ser reflexo de uma série de webinars que foram disponibilizados no portal da Agência e que possam ter auxiliado as empresas a melhor instruir os processos e consequentemente obterem menores índices de indeferimento de petições.

Primeira Manifestação/ Publicação

Em relação à primeira manifestação da Agência (primeira publicação ou exigência de uma petição) o tempo médio no 2º trimestre de 2019 foi de 31,82 dias, sendo o mais baixo em todos os trimestres desde o início de 2018. Certamente, este bom desempenho deve-se à entrada em vigor do regime de Notificação, processo que não exige análise técnica e que tem seu tempo médio de publicação entre 10 e 20 dias. Já, ao analisarmos isoladamente a primeira publicação, o tempo médio cresce para 74,90 dias. Houve um aumento do tempo médio de publicação de cadastros (classe II) e registros em relação ao ano anterior, mas de qualquer maneira, comparando com os resultados históricos, os números de 2019 ainda são mais satisfatórios. Espera-se que com o advento do regime de Notificação, as equipes técnicas consigam ter maior dedicação às petições de cadastro e registro levando a uma redução deste tempo médio.

Quando avaliados os indicadores das Gerências (GEMAT, GQUIP, GEVIT) em separado verificam-se resultados que compartilham as mesmas tendências, o que demonstra que as diferentes áreas da GGTPS estão trabalhando de forma consistente e em consonância.

O Relatório de Produtividade traz ainda alguns destaques do trimestre, dentre eles uma série de eventos regulatórios nacionais e internacionais em que a Gerência teve participação e algumas publicações relevantes da área, como por exemplo, a implementação do regime de Notificação e a publicação de documento para consulta pública no tema de Dispositivos Médicos sob Medida.

Para download do Segundo Relatório Trimestral de Produtividade da GGTPS de 2019 acesse: http://portal.anvisa.gov.br/documents/33912/264658/Relat%C3%B3rio+Trimestral+de+Produtividade+GGTPS+-+2%C2%BA+trimestre+2019/5f5c315b-6b76-44fe-bd12-4a130a52cf01

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

Equipe DOMO Salute

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