Podcast Episodes
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Certificate of Free Sale: Who Is Eligible to Apply?
This episode clarifies the complex eligibility requirements for obtaining a Certificate of Free Sale (FSC) for medical device exports. We dissect the…
1 year, 1 month ago
Navigating FDA Export Certificates: Timelines, Fees, and 2024 Updates
This episode demystifies the process of obtaining a Certificate to Foreign Government (CFG), also known as a Free Sale Certificate (FSC), from the US…
1 year, 1 month ago
Unlocking the FDA 510(k) with Your Japanese PMDA Approval
Many companies believe that getting medical device approval in Japan might fast-track their entry into the U.S. market. This episode breaks down that…
1 year, 1 month ago
From China to Brazil: Navigating ANVISA without NMPA Reliance
This episode clarifies whether a medical device approved by China's NMPA can benefit from an expedited registration process with Brazil's ANVISA. We …
1 year, 1 month ago
From Brazil to the US: Unpacking ANVISA and FDA 510(k) Pathways
This episode tackles a common question from MedTech manufacturers: can a successful ANVISA registration in Brazil streamline the path to FDA 510(k) c…
1 year, 1 month ago
From NMPA to CE Mark: Bridging the Regulatory Gap
This episode breaks down the essential differences between China's NMPA approval and the EU's rigorous MDR CE marking process. We explore the key gap…
1 year, 1 month ago
From Tokyo to Brussels: Navigating the EU MDR After Japan Shonin
Securing Shonin approval in Japan is a huge regulatory achievement, but it doesn’t guarantee a simple path to the European market. This episode break…
1 year, 1 month ago
From NMPA to FDA: Leveraging China Approval for U.S. Market Entry
This episode details the process for medical device manufacturers to obtain FDA 510(k) clearance in the United States after securing Class III approv…
1 year, 1 month ago
From Europe to Down Under: A Guide to TGA Approval with Your CE Mark
This episode breaks down the process of using your existing European CE Marking to register a medical device in Australia. We cover the essential rol…
1 year, 1 month ago
De Novo Submissions: Will Your CE Mark Data Pass FDA Scrutiny?
This episode explores how medical device manufacturers can effectively use their existing CE mark clinical data for an FDA De Novo submission for a n…
1 year, 1 month ago