America
Brazil
A Brazil Registration Holder (BRH) is a crucial intermediary for foreign medical device manufacturers aiming to register their products with Brazil’s National Health Surveillance Agency (ANVISA). When a manufacturer lacks a physical presence in Brazil, they must appoint a BRH to manage the device registration process. The BRH assumes responsibility for liaising with ANVISA and is prominently identified on the device registration.
Selecting the right BRH is essential, as they control registrations and the Brazil Good Manufacturing Practice (B-GMP) certification, which can be challenging to transfer once assigned. Opting for an independent ANVISA representative offers greater flexibility and control over the registration process, safeguarding intellectual property and regulatory compliance, compared to relying on distributors who prioritize sales and marketing over regulatory matter
Colombia
In accordance with Decree 4725/2005, foreign medical device manufacturers seeking market access in Colombia must appoint a licensed attorney in the country to act as their Legal Representative. This legal representative is responsible for managing the device registration process and serving as the interface with Colombia’s medical device regulatory authority,
INVIMA, on behalf of the manufacturer. The relationship with the Legal Representative must be maintained as long as the medical device is marketed in Colombia. Transferring registrations in Colombia is possible, but it typically requires the agreement of the original owner(s). However, if a distributor is involved as the owner, they may be hesitant to relinquish control of the application, often leading companies to opt for the submission of a new application.
Mexico
At Titans Medical, we are your trusted partner for navigating the process of medical device registration in Mexico. The Mexican healthcare market is dynamic and promising, and we understand the nuances of compliance with COFEPRIS regulations. COFEPRIS, the Federal Commission for the Protection against Sanitary Risk, oversees medical device registrations in Mexico, ensuring the safety and efficacy of these devices for the benefit of patients and healthcare professionals.
Titans Medical is committed to guiding you through every step of the registration process, ensuring that you meet all COFEPRIS requirements and standards. Our comprehensive services cover initial assessments, meticulous documentation preparation, and expert guidance to help you confidently introduce your innovative medical devices to the Mexican market. Titans Medical is here to be your steadfast partner in achieving a smooth and successful medical device registration process in Mexico.
How can we help you?
Contact us using the link below and submit your business enquiry.