Medical device industry has been a booming industry with new technologies being introduced from time to time and has been dynamic in terms of Regulatory landscape. The year 2020 has seen a major disruption due to the COVID-19 Pandemic and demanded the Health Agencies to gear up for addressing the pressing situation, thus impacting the Agency’s plan of action.
-
January 5, 2021 Medical Devices, Regulatory Affairs -
November 19, 2020 Medical DevicesMedical devices are evolving and embracing the technologies, so are the Regulatory pathways to govern them. To add to the same, the Brazilian national Health Authority – ANVISA, has published a guidance dedicated to the software with the intended medical purpose (Software as Medical Device – SaMD).
-
November 19, 2020 Medical DevicesBrazil’s National Agency of Health Surveillance (ANVISA) published a new Resolution of the Collegiate Board of Directors (RDC No. 423/2020). The new resolution declared the elimination of the Cadastro registration pathway for Class II medical devices and IVDs and substituted the same with a notification registration pathway (Notificação).
-
December 4, 2018 Regulatory LabelingThe National Health Regulatory Agency (ANVISA) of Brazil, on 22 November 2018, published a new standard - Resolution RDC 250/2018 related to the Official Gazette of the Union. The new resolution, related to Cosmetics labeling, was passed to enhance the agility of the cosmetics sector in Brazil and reduce the cost of labeling processes to the organizations.
-
November 9, 2018 Cosmetics Regulatory ServicesThe Brazilian Association of personal hygiene, perfumery and cosmetics (ABIHPEC) announced a Regulatory revolution for the Brazilian cosmetics industry. The Health Surveillance Agency (ANVISA) has modified resolution RDC 07/2015 to simplify the regulations put on children products. The reformed resolution removes the obligation of registering the product before launching it into the market.
-
August 30, 2018 Cosmetics Regulatory ServicesBrazil’s cosmetic market is flourishing, showing no signs of slowdown even in the economic fluctuations. In Brazil, cosmetics in various segments such as organic, skincare, haircare, etc. are gaining popularity among users, and their market extent is increasing day by day.