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O Mercado Brasileiro é visto por muitas empresas de produtos médicos, como um mercado cheio de possibilidades, porém pode causar espanto devido as particularidades e burocracias que muitas vezes as empresas encontram.
Considerando que a ANVISA (Agência Nacional de Vigilância Sanitária) é uma agência muito bem estruturada, porém relativamente nova em relação ao FDA, por exemplo, a dinâmica e velocidade com que novos regulamentos e ajustes ocorrem, torna complexo o entendimento por empresas estrangeiras em relação ao melhor caminho para aprovar seus produtos. Muitas vezes, criando barreiras e resistências para trazer os produtos ao Brasil por entendimentos equivocados e até obsoletos, uma vez que tem havido esforços significativos no sentido de harmonização e simplificação de alguns procedimentos.
Nos últimos anos, a ANVISA tem sido um dos órgãos reguladores mais atuantes em iniciativas internacionais de harmonização de normas regulatórias, como o Fórum Internacional de Reguladores de Dispositivos Médicos, o IMDRF e o programa de Auditoria Única de Dispositivos Médicos, o MDSAP como uma substituição para auditorias in loco, que efetivamente encerrou a etapa mais demorada no registro dos produtos de risco III e IV e a obtenção de Certificação de Boas Práticas obrigatória para os registros destas categorias.
O Programa de Auditoria única em Produtos para saúde – MDSAP, busca a convergência regulatória, promovendo, a longo prazo, maior alinhamento global das abordagens regulatórias baseados em padrões internacionais de Boas Práticas e regulação sanitária mais efetiva e eficiente. O programa tem o objetivo de permitir uma única auditoria com foco na ISO 13485 e itens específicos das entidades reguladoras de cada país, para satisfazer os requisitos regulatórios dos participantes, o que consequentemente, gera maior confiança em seus resultados.
Uma outra característica do programa MDSAP é a celeridade de renovações de Boas Práticas de Fabricação, onde em sua maioria, as empresas conseguem a renovação do certificado através de análise documental e consequentemente, podem obter o registro e comercialização dos produtos de forma muito mais ágil.
Veja como a obtenção do Certificado MDSAP pode ajudar a sua empresa.
As etapas destacadas em vermelho não são necessárias para os participantes do programa MDSAP, o que pode reduzir o prazo de obtenção do certificado em relação ao procedimento convencional.
A Anvisa também estuda com veemência aumentar o prazo de validade da certificação de Boas Práticas de Fabricação internacional, de 2 para 4 anos, para os participantes do programa MDSAP, o que é bastante interessante como perspectiva de redução futura de custos de manutenção dos registros.
Desta forma, o certificado via MDSAP se destaca como um dos principais facilitadores atualmente para a obtenção do certificado de Boas Práticas.
Obviamente, para o sucesso do projeto serão necessários outros fatores, como estudos clínicos adequados e testes de eficácia e segurança em conformidade com os requisitos da legislação, por exemplo.
Por fim, cabe a cada empresa definir suas próprias estratégias, mas um dos principais motivos de sucesso no mercado brasileiro de produtos para saúde pode ser um fator externo: uma parceria sólida com quem conhece o caminho para contornar todas as adversidades que esse diversificado mercado exige e nós da Equipe Vera Rosas sabemos o caminho certo e estamos prontos para te ajudar.
Todo o conteúdo foi elaborado e cedido por nossa parceira Vera Rosas Registro e Legalização.
www.verarosas.com.br
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Many medical device companies see the Brazilian market as a market full of possibilities, but it can cause astonishment due to the peculiarities and bureaucracies that companies often find.
Considering that ANVISA is a very well-structured agency, but relatively new compared to the FDA, for example, the dynamics and speed with which new regulations and adjustments take place, makes it difficult for foreign companies to understand the best way to approve their products. Often, creating barriers and resistance to bring products to Brazil due to misunderstandings and even obsolete, since there have been significant efforts towards harmonization and simplification of some procedures.
In last couple of years, ANVISA has been one of the most active regulatory bodies in international initiatives for harmonizing regulatory standards, such as the International Medical Device Regulators Forum, IMDRF and the Single Medical Device Audit program, MDSAP, as a replacement for on-site audits, which effectively ended the longest stage in the registration of risk products III and IV and obtaining mandatory Good Manufacturing Practice Certification for the registration of these product classes.
The Medical Device Single Audit Program – MDSAP – seeks regulatory convergence, promoting, in the long run, greater global alignment of regulatory approaches based on international best practice standards and more effective and efficient health regulation. The program aims to allow a single audit with focus on ISO 13485 and specific items of the regulatory authorities of each country, to satisfy the regulatory requirements of the participants, which consequently generates greater confidence in its results. Another characteristic of the MDSAP program is the speed with which Good Manufacturing Practices are renewed, where most companies manage to renew the certificate through document analysis and, consequently, can obtain the registration and commercialization of products much more quickly. See how obtaining the MDSAP Certificate can help your company.The steps highlighted in red are not necessary for participants of the MDSAP program, which can reduce the time to obtain the certificate in relation to the conventional procedure.
Anvisa is also vigorously studying to increase the validity period of the certification of International Good Manufacturing Practices for MDSAP program participants, from 2 to 4 years, which is quite interesting as a perspective of future reduction of registration maintenance costs. In this way, the certificate via MDSAP stands out as one of the main facilitators currently for obtaining the Good Manufacturing Practices certificate. Obviously, other factors will be necessary for the success of the project, such as adequate clinical studies and tests of efficacy and safety in accordance with the requirements of the legislation, for example. Finally, it is up to each company to define its own strategies, but one of the main reasons for success in the Brazilian market for medical devices may be an external factor: a solid partnership with those who know the way to overcome all the adversities that this diverse market requires and our team in Vera Rosas know the right way and are ready to help you.
The text was prepared and provided by Vera Rosas – Regulatory Affairs
www.verarosas.com.br
Material sujeito a mudança (s) em caso de alteração na (s) portaria (s). Publicado em: 09.12.20[:en]Many medical device companies see the Brazilian market as a market full of possibilities, but it can cause astonishment due to the peculiarities and bureaucracies that companies often find.
Considering that ANVISA is a very well-structured agency, but relatively new compared to the FDA, for example, the dynamics and speed with which new regulations and adjustments take place, makes it difficult for foreign companies to understand the best way to approve their products. Often, creating barriers and resistance to bring products to Brazil due to misunderstandings and even obsolete, since there have been significant efforts towards harmonization and simplification of some procedures.
In last couple of years, ANVISA has been one of the most active regulatory bodies in international initiatives for harmonizing regulatory standards, such as the International Medical Device Regulators Forum, IMDRF and the Single Medical Device Audit program, MDSAP, as a replacement for on-site audits, which effectively ended the longest stage in the registration of risk products III and IV and obtaining mandatory Good Manufacturing Practice Certification for the registration of these product classes.
The Medical Device Single Audit Program – MDSAP – seeks regulatory convergence, promoting, in the long run, greater global alignment of regulatory approaches based on international best practice standards and more effective and efficient health regulation. The program aims to allow a single audit with focus on ISO 13485 and specific items of the regulatory authorities of each country, to satisfy the regulatory requirements of the participants, which consequently generates greater confidence in its results. Another characteristic of the MDSAP program is the speed with which Good Manufacturing Practices are renewed, where most companies manage to renew the certificate through document analysis and, consequently, can obtain the registration and commercialization of products much more quickly. See how obtaining the MDSAP Certificate can help your company.The steps highlighted in red are not necessary for participants of the MDSAP program, which can reduce the time to obtain the certificate in relation to the conventional procedure.
Anvisa is also vigorously studying to increase the validity period of the certification of International Good Manufacturing Practices for MDSAP program participants, from 2 to 4 years, which is quite interesting as a perspective of future reduction of registration maintenance costs. In this way, the certificate via MDSAP stands out as one of the main facilitators currently for obtaining the Good Manufacturing Practices certificate. Obviously, other factors will be necessary for the success of the project, such as adequate clinical studies and tests of efficacy and safety in accordance with the requirements of the legislation, for example. Finally, it is up to each company to define its own strategies, but one of the main reasons for success in the Brazilian market for medical devices may be an external factor: a solid partnership with those who know the way to overcome all the adversities that this diverse market requires and our team in Vera Rosas know the right way and are ready to help you.
The text was prepared and provided by Vera Rosas – Regulatory Affairs
www.verarosas.com.br
Material sujeito a mudança (s) em caso de alteração na (s) portaria (s). Publicado em: 09.12.20[:]
