Brazilian Health Products Market x MDSAP
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
Material sujeito a mudança (s) em caso de alteração na (s) portaria (s). Publicado em: 09.12.20