The medical device sector in Argentina and Brazil is experiencing robust growth and development to keep up with the demand in more comprehensive options to diagnose, prevent, and treat complicated conditions. Indeed, rising healthcare demands and an increase in the awareness of advanced medical technologies propel a surge in the adoption of innovative devices. Coupled with this is the evolving regulatory landscape that further supports the flourishing medical device sector in Argentina and Brazil, making them key players in the global healthcare innovation landscape.
While the current regulatory requirements facilitate access to safe, effective, and high-quality medical devices, they can also hinder the timely introduction of devices, particularly low-risk devices. This can be attributed to the intricate and time-consuming regulatory processes. These devices may have the potential to enhance healthcare accessibility. Thus, there is a need for a more balanced approach and to ease regulatory requirements for such devices.
Mutual Recognition Agreement
In order to streamline regulatory processes and enhance collaboration, ANVISA and ANMAT have signed the first Mutual Recognition Agreement (MRA) for “Free Sale Certificates and Certificates for Foreign Country for Medical Devices of Risk Classes I and II and Medical Devices for In Vitro Diagnosis of Risk Classes A and B”. This MRA demonstrates efforts and advancement bring made for cooperation and convergence between ANVISA and ANMAT to simplify regulatory procedures and facilitate bilateral trade.
This collaborative effort eliminates redundancy in the certification process, facilitating the entry of medical devices into both markets. The agreement streamlines regulatory processes, leading to increased efficiency in the approval of medical devices. Medical devices must be classified based on the medical device classification system of ANVISA & ANMAT, and comply with labelling requirements, in order to benefit from the MRA. These devices must also have a certificate of free sale and certificate for a foreign country that has been issued by the regulatory authority of the country of origin. This must be recognized by ANVISA and ANMAT, without the need for apostille and translation. Devices must also be GMP-compliant.
The agreement is a tangible outcome of the “Action Plan for the Relaunch of the Brazil-Argentina Strategic Alliance,” reflecting a commitment to strengthening ties between the two countries. The collaboration between ANVISA and ANMAT sets a precedent for regional cooperation, advancing Latin America’s position in the global medical device market.
The Mutual Recognition agreement between ANVISA and ANMAT mark significant steps toward regional collaboration as well as optimizing regulatory processes & resources to enhance healthcare outcomes and fostering economic growth across borders. As these initiatives continue to unfold, the collective goal of both countries is to position Latin America as a formidable player in the global medical device arena.
DDReg is globally reputed regulatory affairs and pharmacovigilance service provider that has supported its customers with product registration and lifecycle management for various LatAm markets including Argentina and Brazil. Read more from DDReg’s experts on Advancing Healthcare through Electronic Product Information.