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Regain Control: Switching Your Medical Device Registration Holder in Peru

Regain Control: Switching Your Medical Device Registration Holder in Peru

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 This episode explores the critical risks of allowing a distributor to hold your medical device registration in Peru and outlines the strategic advantages of using an independent Peru Registration Holder (PRH). We discuss how this decision impacts your market control, business flexibility, and long-term security. Learn about the process of transferring registration ownership with DIGEMID and why separating your regulatory representation from your commercial partnerships is essential for success. • What is a Peru Registration Holder (PRH) and why is it mandatory? • Are you putting your market access at risk by letting your distributor hold your DIGEMID registration? • What happens to your device registration if you change distributors in Peru? • How does an independent registration holder give you more control and flexibility? • What is the process for transferring registration ownership from a distributor to an independent holder? • Which key regulations, like Decree No. D.S. 029-2015-SA, govern this change? • Why is selecting the right PRH a critical strategic decision for long-term success in Peru? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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