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Brazil's IVD Shake-up: ANVISA RDC 830/2023 and New Risk Classifications
This episode provides a detailed analysis of Brazil's new IVD regulation, ANVISA RDC 830/2023, which was implemented in June 2024. We explore the cri…
11 months, 1 week ago
ANVISA RDC 751/2022: A Manufacturer's Guide to Brazilian Device Registration
This episode provides a detailed overview of Brazil's pivotal medical device regulation, ANVISA RDC 751/2022, which became effective in March 2023. W…
11 months, 1 week ago
Singapore MedTech: How to Break Free from Distributor Lock-In
This episode delves into the critical process for medical device manufacturers to regain control of their Singapore market access by transitioning fr…
11 months, 1 week ago
Unlocking Your MedTech in Vietnam: The Registration Holder Dilemma
This episode delves into the critical process of changing a medical device registration holder in Vietnam. We clarify a common misconception: a direc…
11 months, 1 week ago
Japan's D-MAH System: Regaining Control of Your Medical Device
This episode explores the critical strategic choice between appointing a distributor versus an independent Designated Marketing Authorization Holder …
11 months, 1 week ago
Australia TGA Sponsor: How to Take Control of Your Medical Device Registration
This episode delves into the strategic process of changing a TGA Sponsor for medical devices in Australia. We explore the critical differences betwee…
11 months, 1 week ago
Unlocking India: The Strategic Advantage of an Independent Authorized Agent
This episode explores the critical process of switching your Indian Authorized Agent (IAA) with the CDSCO, moving from a commercially-tied distributo…
11 months, 2 weeks ago
Regain Control: Transferring Your ANMAT Registration in Argentina
This episode delves into the critical process of transferring ANMAT medical device registration in Argentina from a distributor to an independent hol…
11 months, 2 weeks ago
Unlock Chile: Why Your Distributor Shouldn't Own Your Medical Device Registration
This episode explores a crucial, often overlooked aspect of entering the Chilean medical device market: the selection of an in-country registration h…
11 months, 2 weeks ago
Regain Control: Switching Your Medical Device Registration Holder in Peru
This episode explores the critical risks of allowing a distributor to hold your medical device registration in Peru and outlines the strategic advant…
11 months, 2 weeks ago