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Listen "Cracking the Code of LATAM MedTech with Pure Global: A Deep Dive into Peru's Supreme Decree 016-2011-SA and its Impact on Medical Device Registration"
Episode Synopsis
In this episode of LATAM MedTech Insights, we demystify the medical device registration process in Peru by taking a close look at the foundational regulation: Supreme Decree Nº 016-2011-SA. We explore how the national authority, DIGEMID, uses a risk-based classification system and what this means for your specific device.
We break down the critical requirements that often create barriers for foreign manufacturers, including the mandatory appointment of a Peruvian Registration Holder (PRH) and the specific documentation needed for your submission dossier. This episode provides essential, practical insights for any MedTech company considering Peru as their next market.
A Real-World Challenge: Imagine your company has a CE-marked Class III device ready for the LATAM market. You find a distributor in Peru, but your shipment is stopped at customs. Why? Because you didn't appoint a Peruvian Registration Holder (PRH) and your technical dossier wasn't submitted to DIGEMID according to the specific rules of Supreme Decree 016-2011-SA. This episode breaks down how to avoid this costly and time-consuming mistake.
What you'll learn in this episode:
1. What is the primary role of Supreme Decree 016-2011-SA in Peru's MedTech landscape?
2. How does Peru's risk classification system (Class I-IV) impact your registration strategy?
3. Why is a Peruvian Registration Holder (PRH) mandatory for all foreign manufacturers?
4. What is a Certificate of Free Sale, and why is it critical for your application to DIGEMID?
5. What are the most common documentation and language pitfalls for companies entering Peru?
6. How long is a Sanitary Registration valid, and what does the renewal process involve?
7. What are the key differences in requirements for low-risk versus high-risk devices?
At Pure Global, we specialize in transforming these regulatory hurdles into market opportunities. We offer end-to-end solutions, from acting as your local Peruvian Registration Holder to compiling and submitting your technical dossiers with our advanced AI tools. Stop letting complex regulations slow down your LATAM expansion. Contact us at [email protected] or visit https://pureglobal.com/ to streamline your market access.
We break down the critical requirements that often create barriers for foreign manufacturers, including the mandatory appointment of a Peruvian Registration Holder (PRH) and the specific documentation needed for your submission dossier. This episode provides essential, practical insights for any MedTech company considering Peru as their next market.
A Real-World Challenge: Imagine your company has a CE-marked Class III device ready for the LATAM market. You find a distributor in Peru, but your shipment is stopped at customs. Why? Because you didn't appoint a Peruvian Registration Holder (PRH) and your technical dossier wasn't submitted to DIGEMID according to the specific rules of Supreme Decree 016-2011-SA. This episode breaks down how to avoid this costly and time-consuming mistake.
What you'll learn in this episode:
1. What is the primary role of Supreme Decree 016-2011-SA in Peru's MedTech landscape?
2. How does Peru's risk classification system (Class I-IV) impact your registration strategy?
3. Why is a Peruvian Registration Holder (PRH) mandatory for all foreign manufacturers?
4. What is a Certificate of Free Sale, and why is it critical for your application to DIGEMID?
5. What are the most common documentation and language pitfalls for companies entering Peru?
6. How long is a Sanitary Registration valid, and what does the renewal process involve?
7. What are the key differences in requirements for low-risk versus high-risk devices?
At Pure Global, we specialize in transforming these regulatory hurdles into market opportunities. We offer end-to-end solutions, from acting as your local Peruvian Registration Holder to compiling and submitting your technical dossiers with our advanced AI tools. Stop letting complex regulations slow down your LATAM expansion. Contact us at [email protected] or visit https://pureglobal.com/ to streamline your market access.
More episodes of the podcast LATAM MedTech Insights
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23/09/2025
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