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Listen "Navigating LATAM MedTech Regulations for Surgical Instruments & ESUs: A Pure Global Guide to Brazil's ANVISA & Mexico's COFEPRIS"
Episode Synopsis
In this episode of LATAM MedTech Insights, we dissect the complex regulatory pathways for two key medical device categories in Latin America: surgical instrument sets and electrosurgical units. We explore the fragmented nature of LATAM regulations, moving beyond generalities to offer specific, actionable insights.
We delve into the critical "family grouping" strategies required by Brazil's ANVISA for large instrument sets and contrast them with the requirements of Mexico's COFEPRIS. For active devices, we uncover the often-overlooked mandatory electrical safety certifications, like INMETRO in Brazil, that can halt a product launch in its tracks, even after clinical approval seems within reach.
A common pain point for manufacturers is seeing their state-of-the-art electrosurgical unit, with CE Marking and FDA clearance, get stuck for an extra nine months before entering the massive Brazilian market. The reason? They were unaware that their existing electrical safety test reports were not enough and that mandatory, in-country INMETRO testing was required from the start. This oversight leads to unforeseen costs, major timeline delays, and loss of first-mover advantage.
Key questions answered in this episode:
- How can I register a surgical set with over 100 instruments in Brazil without filing 100 separate applications?
- What is the critical non-medical certification required for electronic devices in Brazil that many companies miss?
- Why is a local "Registration Holder" non-negotiable for market access in countries like Mexico and Brazil?
- How do the registration requirements for a simple scalpel differ from a complex electrosurgical generator in Colombia?
- Why isn't my FDA 510(k) or CE Mark a direct passport for market entry in Latin America?
- What are the realistic timelines for getting a medical device approved by ANVISA versus COFEPRIS?
- How can a proactive regulatory strategy for LATAM save hundreds of thousands of dollars in potential delays?
At Pure Global, we specialize in navigating these complexities. We offer end-to-end regulatory consulting solutions for MedTech and IVD companies, acting as your local registration holder and managing the entire submission process with our in-country experts and advanced AI tools. Don't let regulatory hurdles block your expansion. Contact us at [email protected] or visit https://pureglobal.com/ to learn how we can streamline your market access.
We delve into the critical "family grouping" strategies required by Brazil's ANVISA for large instrument sets and contrast them with the requirements of Mexico's COFEPRIS. For active devices, we uncover the often-overlooked mandatory electrical safety certifications, like INMETRO in Brazil, that can halt a product launch in its tracks, even after clinical approval seems within reach.
A common pain point for manufacturers is seeing their state-of-the-art electrosurgical unit, with CE Marking and FDA clearance, get stuck for an extra nine months before entering the massive Brazilian market. The reason? They were unaware that their existing electrical safety test reports were not enough and that mandatory, in-country INMETRO testing was required from the start. This oversight leads to unforeseen costs, major timeline delays, and loss of first-mover advantage.
Key questions answered in this episode:
- How can I register a surgical set with over 100 instruments in Brazil without filing 100 separate applications?
- What is the critical non-medical certification required for electronic devices in Brazil that many companies miss?
- Why is a local "Registration Holder" non-negotiable for market access in countries like Mexico and Brazil?
- How do the registration requirements for a simple scalpel differ from a complex electrosurgical generator in Colombia?
- Why isn't my FDA 510(k) or CE Mark a direct passport for market entry in Latin America?
- What are the realistic timelines for getting a medical device approved by ANVISA versus COFEPRIS?
- How can a proactive regulatory strategy for LATAM save hundreds of thousands of dollars in potential delays?
At Pure Global, we specialize in navigating these complexities. We offer end-to-end regulatory consulting solutions for MedTech and IVD companies, acting as your local registration holder and managing the entire submission process with our in-country experts and advanced AI tools. Don't let regulatory hurdles block your expansion. Contact us at [email protected] or visit https://pureglobal.com/ to learn how we can streamline your market access.
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