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Unlocking the Peruvian MedTech Market: A Pure Global Breakdown of Medical Device Registration Costs and Hidden Fees in LATAM
This episode of LATAM MedTech Insights dives deep into the real costs of registering a medical device in Peru. We uncover why the official DIGEMID government fees are just the tip of the iceberg and explore the significant hidden expenses in local representation, technical dossier translation, and costly time delays that can derail your market entry strategy.
We break down the critical strategic decision of appointing a Peru Registration Holder (PRH). Imagine a medical device scaleup, excited to enter the Peruvian market. They budget for the official fees but are blindsided when their registration is tied to a single distributor who holds their market access hostage. This common pitfall prevents them from expanding their commercial network and costs them a year in lost revenue to fix. This episode teaches you how to avoid this and other costly mistakes.
Key Takeaways:
* Why are official government fees only 10% of your total registration cost in Peru?
* What is a Peru Registration Holder (PRH), and why is choosing the wrong one a critical strategic mistake?
* How can simple Spanish translation errors lead to a complete dossier rejection by DIGEMID?
* What are the hidden operational costs associated with preparing a technical file for the Peruvian market?
* How can you leverage existing approvals like an FDA 510(k) or a CE Mark to potentially speed up your process?
* What is the true opportunity cost of a 12-month registration delay, and how can you mitigate it?
* Why is an independent local representative often a better long-term investment than your distributor?
At Pure Global, we provide end-to-end regulatory consulting to help MedTech companies navigate complex markets like Peru. Our integrated approach combines local, in-country expertise with advanced AI tools to streamline dossier preparation, manage submissions, and act as your independent local representative. We turn regulatory hurdles into market opportunities. To secure and accelerate your market access in Latin America, contact us at [email protected] or visit https://pureglobal.com/.
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By Ran ChenThis episode of LATAM MedTech Insights dives deep into the real costs of registering a medical device in Peru. We uncover why the official DIGEMID government fees are just the tip of the iceberg and explore the significant hidden expenses in local representation, technical dossier translation, and costly time delays that can derail your market entry strategy.
We break down the critical strategic decision of appointing a Peru Registration Holder (PRH). Imagine a medical device scaleup, excited to enter the Peruvian market. They budget for the official fees but are blindsided when their registration is tied to a single distributor who holds their market access hostage. This common pitfall prevents them from expanding their commercial network and costs them a year in lost revenue to fix. This episode teaches you how to avoid this and other costly mistakes.
Key Takeaways:
* Why are official government fees only 10% of your total registration cost in Peru?
* What is a Peru Registration Holder (PRH), and why is choosing the wrong one a critical strategic mistake?
* How can simple Spanish translation errors lead to a complete dossier rejection by DIGEMID?
* What are the hidden operational costs associated with preparing a technical file for the Peruvian market?
* How can you leverage existing approvals like an FDA 510(k) or a CE Mark to potentially speed up your process?
* What is the true opportunity cost of a 12-month registration delay, and how can you mitigate it?
* Why is an independent local representative often a better long-term investment than your distributor?
At Pure Global, we provide end-to-end regulatory consulting to help MedTech companies navigate complex markets like Peru. Our integrated approach combines local, in-country expertise with advanced AI tools to streamline dossier preparation, manage submissions, and act as your independent local representative. We turn regulatory hurdles into market opportunities. To secure and accelerate your market access in Latin America, contact us at [email protected] or visit https://pureglobal.com/.