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 [email protected] for tailored support.

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 [email protected] for tailored support.

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 [email protected] for tailored support.

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 [email protected] for tailored support.

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 [email protected] for tailored support.

This episode explores the critical shift for medical device manufacturers from using a distributor as their EU Authorized Representative (EC-REP) to appointing a professional, independent representative in France. We delve into the increased liabilities under the MDR, the inherent conflicts of interest in the distributor model, and the significant commercial and regulatory advantages of partnering with an independent AR for streamlined access to the French and broader EU markets.

• Why is using a distributor as your EU Authorized Representative now considered a major risk?

• What specific liabilities did the EU MDR place on Authorized Representatives?

• How does an independent EC-REP provide greater market flexibility in France and across the EU?

• What is the fundamental conflict of interest between a distributor's goals and an AR's duties?

• What are the key steps involved in switching from a distributor to an independent AR?

• How does this change affect your product labeling and registration?

• Why is a formal transfer agreement essential for a smooth transition?

• How can an independent AR improve your relationship with competent authorities like France's ANSM?

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 [email protected] for tailored support.

This episode details the strategic process for medical device manufacturers to transition from a distributor-based EU Authorized Representative (EC-REP) to an independent one in Germany. We cover the regulatory requirements under MDR Article 12, the importance of the tripartite agreement, and the necessary steps for a smooth handover, including German database updates and labeling changes.

• Why is using a distributor as an EC-REP a potential conflict of interest?

• What is the first step in terminating an agreement with a distributor-representative?

• What is a tripartite agreement and why is it essential for this change?

• Which specific details must be included in the handover agreement?

• How are post-market surveillance duties handled for devices already on the market?

• Which German authority and database are involved in this process?

• What are the practical implications for product labeling and packaging?

• Do you need to inform your Notified Body about the change in EC-REP?

• What are the key benefits of using an independent EC-REP?

• How does an independent EC-REP better protect a manufacturer's intellectual property?

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 [email protected] for tailored support.

Since Brexit, non-UK medical device manufacturers need a UK Responsible Person (UKRP) to access the Great Britain market. While appointing a local distributor for this role is a common shortcut, it creates a significant conflict of interest between sales and regulatory compliance. This episode explores the hidden risks of this approach—from a lack of regulatory expertise to giving a commercial partner leverage over your market access—and makes the case for appointing a specialized, independent UKRP for long-term business security and continuity.

• What is the UK Responsible Person (UKRP) and why is it mandatory after Brexit?

• Why is appointing a distributor as your UKRP a potential conflict of interest?

• How could a distributor's sales focus compromise your regulatory compliance?

• Does your distributor possess the necessary expertise to engage with the MHRA?

• What happens to your market access if you end your agreement with a distributor who is also your UKRP?

• How does using a distributor as your UKRP risk your confidential technical files?

• What are the key advantages of appointing a dedicated, independent UKRP?

• How does separating regulatory and commercial functions provide business flexibility?

• Is your current UKRP strategy built for long-term success or short-term convenience?

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 [email protected] for tailored support.

This episode explores the critical need for non-EU medical device manufacturers to replace their distributor-based EU Authorized Representative (EC-REP) with an independent one, particularly for the Spanish market. We delve into the increased liabilities for EC-REPs under the EU MDR (Regulation (EU) 2017/745), the inherent conflicts of interest when a distributor holds this role, and the clear benefits of partnering with a neutral, compliance-focused representative. Learn the official step-by-step process for making this crucial transition to secure your market access and protect your intellectual property.

Key Questions:

• Why is using your Spanish distributor as your EU Authorized Representative a major risk under the new MDR?

• What specific liabilities does your EC-REP now share with you for defective devices?

• How does an independent representative protect your confidential technical documentation from competitors?

• What is the official process for changing your EC-REP in Spain?

• How does the tripartite agreement work between the manufacturer, the old rep, and the new one?

• What are the critical labeling changes you must make when you switch representatives?

• Could a conflict of interest with your distributor-rep jeopardize your market access?

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 [email protected] for tailored support.

This episode explores the critical shift for MedTech manufacturers from using distributors to appointing independent Authorized Representatives (EC-REPs) in Italy, driven by the EU's Medical Device Regulation (MDR). We unpack the increased legal liabilities, conflicts of interest, and commercial risks associated with the old model, and explain why an independent AR is now essential for secure and flexible market access.

Key Questions:

• Why is using your Italian distributor as your EU Authorized Representative a major risk under the new MDR?

• What does "jointly and severally liable" mean for your European regulatory partner?

• How does the EU MDR create a conflict of interest for a distributor acting as your AR?

• Can your distributor legally hold your device registrations hostage if you want to switch partners?

• What are the strategic advantages of appointing an independent EC-REP for the Italian market?

• How does separating your regulatory and commercial partners improve your business flexibility?

• What is the primary role of an Authorized Representative in communicating with the Italian Ministry of Health?

• Does your current EU AR agreement protect you from the new liability clauses in Regulation (EU) 2017/745?

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 [email protected] for tailored support.