The Egyptian Drug Authority (EDA) held a virtual meeting with the Brazilian Health Regulatory Agency (ANVISA), with the participation of the EDA’s medical devices team and their Brazilian counterparts, to explore avenues for enhancing regulatory cooperation in the field of medical devices.

The meeting included a review of the regulatory frameworks in place in both countries, covering medical device classification systems based on risk levels, requirements and procedures for medical device registration, various licensing pathways, as well as import procedures and pre-market approval requirements.

Discussions also addressed the use of digital platforms and electronic systems for the submission, review, and tracking of regulatory dossiers, as well as the role of digital transformation in enhancing the efficiency, transparency, and acceleration of registration and licensing processes.

Both sides emphasized the importance of exchanging technical and regulatory expertise between regulatory authorities, contributing to the development of regulatory frameworks, strengthening the efficiency of regulatory systems, and ensuring the availability of safe and effective medical devices in line with international best practices and standards.

The Authority affirmed that strengthening cooperation with international regulatory bodies—particularly the Brazilian Health Regulatory Agency (ANVISA)—represents an important step toward exchanging technical and regulatory expertise in the field of medical devices and advancing the regulatory system in line with international standards. This, in turn, supports the quality and safety of medical devices and enhances the efficiency of regulatory procedures.

This comes as part of the Authority’s ongoing efforts to strengthen collaboration with international regulatory bodies and promote the exchange of knowledge and expertise, thereby supporting the development of the regulatory environment in Egypt and enhancing the quality and safety of medical devices available in the local market.