Podcast Episodes
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Mexico MedTech: Untangling Your COFEPRIS Registration Holder
This episode explores the critical process of transferring a medical device registration holder in Mexico. We uncover the risks of appointing a distr…
11 months, 2 weeks ago
Regain Control: Switching Your INVIMA Holder in Colombia
This episode explores the critical decision of who holds your INVIMA medical device registration in Colombia. We delve into the significant business …
11 months, 2 weeks ago
Brazil's MedTech Market: Escaping the Distributor Trap
This episode delves into a crucial aspect of the Brazilian medical device market: the role of the Brazil Registration Holder (BRH). We explore the si…
11 months, 2 weeks ago
UAE Regulatory Update: Gaining Control with an Independent LAR
This episode explores the pivotal regulatory change in the United Arab Emirates allowing medical device manufacturers to appoint an independent Local…
11 months, 3 weeks ago
SFDA Success: Regain Control by Switching Your Saudi Authorized Representative
This episode explores the critical strategic decision for medical device manufacturers in Saudi Arabia: moving from a distributor-based Local Authori…
11 months, 3 weeks ago
Turkey's New Medical Device Rule: Why Your Distributor Is Now a Liability
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 …
11 months, 3 weeks ago
Switzerland's CH-REP Rule: Is Your Distributor a Compliance Risk?
This episode delves into the critical role of the Swiss Authorized Representative (CH-REP) for medical device manufacturers. We explore the significa…
11 months, 3 weeks ago
EU Medical Devices: Breaking Up with Your Distributor-AR in France
This episode explores the critical shift for medical device manufacturers from using a distributor as their EU Authorized Representative (EC-REP) to …
11 months, 3 weeks ago
Switching Your German EC-REP: From Distributor to Independent Representative
This episode details the strategic process for medical device manufacturers to transition from a distributor-based EU Authorized Representative (EC-R…
11 months, 3 weeks ago
Distributor as UKRP: The Hidden Risk to Your UK Market Access
Since Brexit, non-UK medical device manufacturers need a UK Responsible Person (UKRP) to access the Great Britain market. While appointing a local di…
11 months, 3 weeks ago