Podcast Episodes
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Singapore MedTech Compliance: Mastering the SS 620 GDPMDS Standard for Device Distribution
This episode provides a detailed overview of Singapore's mandatory Good Distribution Practice for Medical Devices (GDPMDS) certification. We explore …
7 months, 2 weeks ago
Singapore MedTech Market: A Guide to HSA's Importer, Wholesaler & Manufacturer Licenses
This episode provides a detailed guide to the three types of medical device dealer licenses required by Singapore's Health Sciences Authority (HSA): …
7 months, 3 weeks ago
Navigating Singapore's HSA: The Class A Medical Device Registration Exemption
This episode delves into a key regulatory pathway in Singapore for low-risk medical devices. We explore the Health Sciences Authority's (HSA) exempti…
7 months, 3 weeks ago
Unlocking Singapore: Mastering the ASEAN CSDT for Medical Device Registration
This episode provides a detailed guide on using the ASEAN Common Submission Dossier Template (CSDT) for medical device registration in Singapore. We …
7 months, 3 weeks ago
Singapore HSA Fast-Track: Leveraging FDA, CE Mark & TGA Approvals for Device Registration
This episode explores Singapore's Health Sciences Authority (HSA) abridged evaluation route, a streamlined pathway for medical device registration. W…
7 months, 3 weeks ago
Singapore MedTech Compliance: Navigating HSA Registrant & Representative Roles
This episode details the mandatory requirement for foreign medical device manufacturers to appoint a Singapore Registrant. We explain the role and re…
7 months, 3 weeks ago
Singapore HSA Pathways: A Guide to Immediate, Expedited & Abridged MedTech Registration
This episode provides a detailed guide to the Singapore Health Sciences Authority (HSA) medical device registration pathways for Class B, C, and D de…
7 months, 3 weeks ago
Singapore HSA: A Guide to Medical Device Risk Classification (Class A-D)
This episode provides a detailed guide to Singapore's Health Sciences Authority (HSA) medical device risk classification system. We explore the four-…
7 months, 3 weeks ago
Singapore Medical Device Registration: Navigating the HSA & Health Products Act
This episode provides a detailed overview of Singapore's medical device registration framework. We cover the role of the Health Sciences Authority (H…
7 months, 4 weeks ago
Navigating INVIMA: Colombian Rules for Medical Device Labeling, IFU, and Spanish Translation
This episode provides a detailed overview of the regulatory requirements for medical device labeling, Instructions for Use (IFU), and Spanish transla…
7 months, 4 weeks ago