Épisodes

  • Regain Control: Switching Your Medical Device Registration Holder in Peru

    Regain Control: Switching Your Medical Device Registration Holder in Peru
    Nov 4 2025
    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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    3 min
  • Mexico MedTech: Untangling Your COFEPRIS Registration Holder

    Mexico MedTech: Untangling Your COFEPRIS Registration Holder
    Nov 3 2025
    This episode explores the critical process of transferring a medical device registration holder in Mexico. We uncover the risks of appointing a distributor as your legal representative with COFEPRIS and detail the complex legal steps required for a transfer of rights. Learn why choosing an independent registration holder from the outset is the key to maintaining control over your market access and commercial flexibility in this major Latin American market. Key Questions: • What is a Mexico Registration Holder (MRH) and why are they legally significant? • What are the hidden dangers of letting your distributor own your COFEPRIS registration? • Can you be locked out of the Mexican market by a former distributor? • What is the official "transfer of rights" process for a medical device registration? • What legal documents and cooperation are required from the original registration holder? • Why might a distributor refuse to transfer your registration? • What is the costly alternative to a smooth registration transfer? • How does appointing an independent holder protect your business interests? • Why is separating regulatory ownership from commercial distribution a vital strategy? 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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    3 min
  • Regain Control: Switching Your INVIMA Holder in Colombia

    Regain Control: Switching Your INVIMA Holder in Colombia
    Nov 2 2025
    This episode explores the critical decision of who holds your INVIMA medical device registration in Colombia. We delve into the significant business risks of allowing a distributor to be the registration holder and outline the strategic advantages of using an independent third party. Learn about the process for transferring ownership, the potential pitfalls of an uncooperative distributor, and how to maintain full control over your commercial strategy in this key Latin American market. • What is an INVIMA Registration Holder and why does it critically impact your business? • Are you exposing your company to risk by letting your distributor control your market access? • How does an independent registration holder provide commercial flexibility? • What is the official process for switching your registration holder in Colombia? • What happens if your current distributor refuses to transfer the registration? • Can you work with multiple distributors under a single registration? • How can you avoid being locked into a single commercial partner? • What is the best practice for new companies entering the Colombian market? 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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    3 min
  • Brazil's MedTech Market: Escaping the Distributor Trap

    Brazil's MedTech Market: Escaping the Distributor Trap
    Nov 1 2025
    This episode delves into a crucial aspect of the Brazilian medical device market: the role of the Brazil Registration Holder (BRH). We explore the significant differences and long-term consequences of appointing a distributor versus an independent third party to hold your device registration with ANVISA. Learn how to avoid common pitfalls that can limit your commercial flexibility and gain control over your market strategy. • What is a Brazil Registration Holder (BRH) and why is it mandatory? • What are the hidden risks of appointing your distributor as your BRH? • How does using a distributor as a BRH limit your ability to change sales partners? • Why is an independent BRH a more strategic choice for market entry? • What are the benefits of separating regulatory holding from commercial distribution? • What does Brazilian Resolution RDC 102/2016 say about transferring a registration? • How can you protect your intellectual property when registering a device in Brazil? • What is the best strategy to ensure long-term control and flexibility in the Brazilian market? 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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    3 min
  • UAE Regulatory Update: Gaining Control with an Independent LAR

    UAE Regulatory Update: Gaining Control with an Independent LAR
    Oct 31 2025
    This episode explores the pivotal regulatory change in the United Arab Emirates allowing medical device manufacturers to appoint an independent Local Authorized Representative (LAR), decoupling registration from commercial distribution. We analyze the risks of the old distributor-as-LAR model and highlight the strategic advantages of the new system, including enhanced market flexibility, greater control over registrations, and improved business continuity for MedTech companies targeting the UAE. • Why was appointing a distributor as your LAR in the UAE a major business risk? • What specific change did the UAE's Ministry of Health and Prevention (MOHAP) implement regarding in-country representation? • How does an independent LAR give manufacturers more control over their products? • What are the key strategic benefits of separating regulatory compliance from commercial sales? • Can you appoint multiple distributors in the UAE after this change without re-registering your device? • What are the core responsibilities of an independent LAR? • How does this shift affect your ability to enter or scale within the UAE market? • Does the manufacturer or the LAR own the device registration under the new model? 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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    3 min
  • SFDA Success: Regain Control by Switching Your Saudi Authorized Representative

    SFDA Success: Regain Control by Switching Your Saudi Authorized Representative
    Oct 30 2025
    This episode explores the critical strategic decision for medical device manufacturers in Saudi Arabia: moving from a distributor-based Local Authorized Representative (LAR) to an independent one. We delve into the significant risks of tying your SFDA product registrations to a commercial partner and outline the clear benefits and straightforward process for making the switch. Learn how to take control of your market access, enhance your strategic flexibility, and secure your business in the Kingdom. • What are the hidden risks of appointing your Saudi distributor as your regulatory representative? • How can a distributor-LAR relationship hold your market access hostage? • What are the strategic advantages of using an independent, third-party LAR? • Is it difficult to switch from a distributor to an independent LAR in Saudi Arabia? • Do you need your current distributor’s permission to make the change? • Will you lose your existing product registrations (MDMA) if you switch representatives? • What does the SFDA require for a smooth transfer process? • Why is this topic more important than ever for low-risk devices since September 2022? 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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    4 min
  • Turkey's New Medical Device Rule: Why Your Distributor Is Now a Liability

    Turkey's New Medical Device Rule: Why Your Distributor Is Now a Liability
    Oct 30 2025
    This episode unpacks a crucial change in Turkey's medical device regulations following its alignment with the EU MDR on June 2, 2021. We explore why foreign manufacturers can no longer use their commercial distributors as their Turkish Authorized Representative (TR-REP). The discussion focuses on the inherent conflict of interest between sales and regulatory compliance, the legal responsibilities of an independent TR-REP, and the necessary steps manufacturers must take to appoint a new representative and update their registrations in the ÜTS database to maintain market access. Key Questions: • Why is using your distributor as your Turkish Authorized Representative (TR-REP) now a significant compliance risk? • What is the fundamental conflict of interest between a distributor's commercial goals and a representative's regulatory duties? • How did Turkey's alignment with the EU MDR on June 2, 2021, fundamentally change the role of the TR-REP? • What are the specific legal responsibilities of an independent TR-REP? • What are the essential steps to transition from a distributor-rep to an independent TR-REP? • How does this regulatory shift affect your device registrations in the Turkish ÜTS database? • What are the potential consequences of failing to appoint an independent TR-REP in Turkey? • Does an independent TR-REP model improve patient safety and post-market surveillance? 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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    3 min
  • Switzerland's CH-REP Rule: Is Your Distributor a Compliance Risk?

    Switzerland's CH-REP Rule: Is Your Distributor a Compliance Risk?
    Oct 29 2025
    This episode delves into the critical role of the Swiss Authorized Representative (CH-REP) for medical device manufacturers. We explore the significant regulatory changes that made the CH-REP mandatory and uncover the hidden risks of appointing a commercial distributor for this function. Learn why an independent CH-REP is the more strategic choice for ensuring long-term compliance and commercial flexibility in the Swiss market. • Why did Switzerland become a regulatory "third country" for medical devices on May 26, 2021? • What are the core duties and legal liabilities of a Swiss Authorized Representative (CH-REP)? • What is the fundamental conflict of interest when your distributor is also your CH-REP? • How does tying regulatory compliance to a sales partner limit your commercial freedom? • Is your distributor truly equipped to handle joint liability for your devices? • What makes an independent CH-REP a more robust and flexible long-term solution? • What is involved in the process of switching from a distributor to an independent CH-REP? • Are there still grace periods for appointing a Swiss representative? 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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    4 min