Podcast Episodes
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Singapore's MedTech Gatekeeper: The Crucial Role of the Local Registrant
This episode demystifies the single most critical requirement for medical device manufacturers entering the Singaporean market: the local Registrant.…
1 year ago
India's Medical Device Market: Your Guide to the Authorized Agent Requirement
This episode breaks down the essential role of the Authorized Indian Agent (AIA) for medical device companies entering the Indian market. We explore …
1 year ago
China's NMPA Gatekeeper: The In-China Domestic Agent Explained
This episode demystifies the mandatory role of the In-China Domestic Agent for foreign medical device manufacturers entering the Chinese market. We e…
1 year ago
Unlocking the Japanese MedTech Market: The DMAH Strategy
This episode demystifies the role of the Designated Marketing Authorization Holder (DMAH) for medical device companies entering Japan. We explore the…
1 year ago
The Australian Gatekeeper: Choosing Your TGA Medical Device Sponsor
This episode delves into the essential role of the Australian Sponsor for medical device companies seeking to enter the Australian market. We explain…
1 year ago
New Zealand MedTech: The Crucial Role of the Local Sponsor
This episode demystifies the process of entering the New Zealand medical device market by focusing on the critical role of the New Zealand Sponsor, a…
1 year ago
Canada's MedTech Entry Pass: MDL vs. MDEL Explained
This episode demystifies Canada's dual-licensing system for medical devices. We clarify the critical differences between a product-specific Medical D…
1 year ago
Unlocking Switzerland: Your Guide to the Swiss Authorised Representative Requirement
This episode unpacks the essential requirements for placing medical devices on the Swiss market following the lapse of the EU-Switzerland Mutual Reco…
1 year ago
Beyond the Mailbox: Your EU Rep's Critical MDR & IVDR Duties
This episode delves into the critical role of the European Authorised Representative (EC REP) for non-EU medical device and IVD manufacturers under t…
1 year ago
Post-Brexit MedTech Compliance: The Crucial Role of the UK Responsible Person
This episode breaks down the essential post-Brexit requirement for non-UK medical device manufacturers: the UK Responsible Person (UKRP). We explore …
1 year ago