Regulatory Challenges in the Importation of Hospital Products in Brazil
An Analysis of the Licensing
DOI:
https://doi.org/10.5281/zenodo.20332331Keywords:
Licensing, Regulation, Importation, ANVISAAbstract
The objective of this study is to analyze the regulatory challenges in the importation of hospital products in Brazil, focusing on the licensing process. The growing dependence on foreign inputs and technologies makes it essential to achieve efficiency in import operations, especially in the healthcare sector. However, the strong role of regulatory authorities, particularly the Agência Nacional de Vigilância Sanitária, imposes a series of technical and administrative requirements that directly impact the operations of importing companies. The methodology adopted is based on qualitative research, with a descriptive and exploratory approach, through bibliographic review and analysis of legislation and official documents. The results indicate that the main challenges faced include documentary complexity, delays in process analysis, frequent regulatory changes, and lack of standardization in requirements. It is observed that, although regulation is essential to ensure health safety, there is a need to seek greater efficiency in processes through simplification and modernization of systems in order to reduce negative impacts on the healthcare supply chain.
Downloads
References
ANVISA - AGÊNCIA NACIONAL DE VIGILÂNCIA SANITÁRIA. Importação de produtos sujeitos à vigilância sanitária. Brasília: ANVISA, 2022. Disponível em: Resolução da Diretoria Colegiada - RDC nº 751, de 15/09/2022 Acesso em: 29 mar. 2026.
BRASIL. Agência Nacional de Vigilância Sanitária. Resolução da Diretoria Colegiada – RDC nº 751, de 15 de setembro de 2022. Dispõe sobre a classificação de risco, regimes de notificação e registro de dispositivos médicos. Brasília, 2022. Disponível em: RDC_751_2022_.pdf Acesso em 05 abr.2026.
BRASIL. Lei nº 9.782, de 26 de janeiro de 1999. Define o Sistema Nacional de Vigilância Sanitária, cria a Agência Nacional de Vigilância Sanitária, e dá outras providências. Brasília, DF: Diário Oficial da União, 1999. Disponível em: http://www.planalto.gov.br/ccivil_03/leis/L9782.htm. Acesso em 05 abr.2026.
BURRIS, Scott et al. The new public health law. Annual Review of Public Health, v. 31, 2010. Disponivel em: Making the Case for Laws That Improve Health: A Framework for Public Health Law Research | Request PDF Acesso em: 05 abr. 2026.
CARVALHO, K. F. S.; SOUZA, A. E. Estudo sobre alternativas logísticas e integração de processos. Advances in Global Innovation & Technology, 2026. Disponível em: https://doi.org/10.5281/zenodo.20215094. Acesso em: 04 abr. 2026.
HINTZE, F. S. et al. Gestão do transporte de cargas e inteligência artificial. Advances in Global Innovation & Technology, 2024. Disponível em: https://doi.org/10.29327/2384439.2.2-9. Acesso em: 04 abr. 2026.
HOEKMAN, Bernard; NICITA, Alessandro. Trade policy, trade costs and developing country trade. World Development, v39, n.12, 2011. Disponível em: https://doi.org/10.1016/j.worlddev.2011.05.013. Acesso em: 05 abr. 2026.
KRUGMAN, Paul R.; OBSTFELD, Maurice; MELITZ, Marc J. Economia Internacional: Teoria e Política. 10. ed. São Paulo: Pearson, 2015.
MAJONE, Giandomenico. From the positive to the regulatory state. Journal of Public Policy, v.17, n.2, 1997.Disponível em: From the Positive to the Regulatory State: Causes and Consequences of Changes in the Mode of Governance | Journal of Public Policy | Cambridge Core. Acesso em: 05 abr. 2026.
OECD (Organisation for Economic Co-operation and Development). Trade Facilitation and the Global Economy. Paris, 2018. Disponível em: Trade Facilitation and the Global Economy (EN) Acesso em: 04 abr. 2026.
OLIVEIRA, Leonardo Pereira de; FLORENCIO, Thayssa de Araujo. Comércio e Produção de Vacinas no Brasil Durante a Pandemia De COVID-19. Advances in Global Innovation & Technology. Disponível em: https://revista.fateczl.edu.br/index.php/git/article/view/346 Acesso em: 6 abr. 2026.
SANTOS, A. S.; BAPTISTA, J. A. Gargalos logísticos no Brasil. Advances in Global Innovation & Technology, 2023. https://doi.org/10.29327/2384439.2.1-5
TURMAN, Ernesto; SALES, Janaina. Breves considerações sobre a eficiência da defesa do consumidor realizada pelos órgãos da administração pública indireta. Revista Brasileira de Direito do Consumidor, Salvador.
WORLD BANK (World Bank). Doing Business 2020. Washington, DC, 2020. Disponível em: https://openknowledge.worldbank.org/handle/10986/32436. Acesso em: 29 mar. 2026.
WORLD TRADE ORGANIZATION (World Trade Organization). World Trade Report 2022. Geneva, 2022. Disponível em: https://www.wto.org/english/res_e/publications_e/wtr22_e.htm. Acesso em: 05 abr. 2026.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2026 Valeria da Silva Costa, Ali Antonio Abrão Junior
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
Copyright Policy
By submitting a manuscript for publication in the journal Advances in Global Innovation & Technology (@_GIT), authors agree, in advance and unrestrictedly, to the following terms:
- The authors retain the copyright and grant to the Journal Advances in Global Innovation & Technology (@_GIT) the right of first publication of the manuscript, without any financial burden, and waive any other remuneration for its publication in the Journal of Advances in Global Innovation & Technology (@_GIT).
- Upon submission to the Journal of Advances in Global Innovation & Technology (@_GIT), the manuscript is automatically licensed under the Creative Commons Attribution License, which allows the sharing of the work with acknowledgment of authorship and initial publication in the Journal Advances in Global Innovation & Technology (@_GIT).
- Authors are authorized to enter into additional contracts separately, for non-exclusive distribution of the version of the work published in the Journal Advances in Global Innovation & Technology (@_GIT) (publish in repositories or as a book chapter), with acknowledgment of the initial publication in the Journal Advances in Global Innovation & Technology (@_GIT), provided that such agreement does not imply an endorsement of the content of the manuscript or the new vehicle by the Journal of Advances in Global Innovation & Technology (@_GIT).
- Authors are allowed and encouraged to publish and distribute their work online, in institutional repositories, for example after the editorial process is completed.
- The authors warrant that they have obtained proper permission from their employers for the transfer of rights under this agreement, if those employers own any copyright in the manuscript. In addition, the authors assume any and all responsibility for possible copyright infringements of these employers, exempting Advances in Global Innovation & Technology (@_GIT) from any and all liability in this regard.
- The authors assume all responsibility for the content of the work, including the due and necessary authorizations for the disclosure of data collected and results obtained, exempting the Journal of Advances in Global Innovation & Technology (@_GIT) from any and all liability in this regard.
