Worldwide Regulatory Convergence for Medical Devices – ANVISA as an active regulatory authority towards this goal
Worldwide Regulatory Convergence for Medical Devices – ANVISA as an active regulatory authority towards this goal
In recent years, ANVISA’s medical devices department has been working with guidelines based on global regulatory convergence and product risk. On the 2020-2023 Strategic Plan, ANVISA (Brazilian National Health Surveillance Agency) expressed interest in adopting regulatory strategies for simplification, mutual recognition between global regulatory agencies, equivalence agreements and expansion of authorized third parties, without losing its autonomy or reducing quality, safety and effectiveness standards. The simplification strategy was shown with the publication of Resolution RDC 270/2019, which established the Notification regime for risk class I medical devices, and have been consolidated with the recent publication of Resolution RDC 423/2020, which establishes the extinction of the Cadastro and migration for risk class II medical devices to the simplified Notification regime, in which there is no technical analysis by the agency prior to granting the registration. With these measures, the Agency aims to reduce the time taken to analyze petitions, as well as to concentrate the efforts of technical teams in the evaluation of higher risk products.
ANVISA’s movements are part of a regulatory plan to seek greater balance between pre-market requirements (technical rigor in the assessment for granting registration) and post-market requirements (inspection actions and improvement of post-market data collection), to improve control of medical devices throughout their life cycle. Thus, assuming an ideal balance between these actions, it will be possible to adopt flexible measures in pre-market control without prejudice to sanitary control.
This direction is also addressed in the strategic plan of the IMDRF (International Medical Device Regulators Forum), an international forum of medical device regulatory entities, of which ANVISA is a founding member. Australia, Brazil, Canada, China, European Union, Japan, USA, Russia, Singapore and South Korea are members of the forum. Through the advances of IMDRF working groups, it was already possible to establish the MDSAP (Medical Device Single Audit Program), a program that enabled a single audit, conducted by a third body recognized by regulatory authorities, to be recognized by the member countries of the MDSAP program (Australia, Brazil, Canada, USA, Japan – Argentina and South Korea recently joined the program). A report from the end of 2019, released by ANVISA, showed a significant increase in adherence to MDSAP, reporting that 44.7% of the total international certifications of Good Manufacturing Practices issued that year had been granted through the use of the program. In addition to saving resources, ANVISA informs that the MDSAP impacts on an increase in the sanitary safety of products, since the auditing bodies inspect companies more frequently, sending reports annually to the Agency and the other authorities participating in the agreement.
Accelerating global regulatory convergence and harmonization is a strategic priority for the IMDRF, aiming to promote an efficient and effective regulatory model for medical devices. Seeking a greater alignment of the international risk classification, ANVISA published two public consultations (CP 730/2019 and 734/2019), proposals for updating the resolutions governing the health risk classification for medical devices in Brazil. These proposals aim to promote that the criteria to determine the risk class of medical devices are even closer to those adopted by jurisdictions that compose the IMDRF. By observing the movements and paying attention to the strategic planning outlined by ANVISA, it is possible to conclude that the actions of the Brazilian agency are quite aligned with the regulatory convergence outlined by the IMDRF. Thus, we can wait for new actions by ANVISA towards this goal.
DOMO Salute Team
www.domosalute.com.br
REFERÊNCIAS:
http://www.imdrf.org/docs/imdrf/final/procedural/imdrf-proc-151002-strategic-plan-2020.pdf
https://www.in.gov.br/web/dou/-/consulta-publica-n-734-de-22-de-outubro-de-2019-223312827