In this episode of MedTech Global Insights, we dissect a crucial, yet often overlooked, aspect of entering one of Asia's premier MedTech hubs: Singapore. We explore the intricacies of the Health Sciences Authority's (HSA) Good Distribution Practice for Medical Devices (GDPMDS), a mandatory certification that governs the entire supply chain. We move beyond the theory to discuss why even companies with robust ISO 13485 certification can fail their audits, leading to costly delays and market access denial. We uncover the common pitfalls and highlight the strategic value of partnering with an expert consultant who possesses deep local knowledge and a global perspective. Consider this real-world pain point: A European IVD startup, fresh off its CE marking, launches in Singapore. However, their license application is suddenly rejected during the final review. The reason? Their local distributor’s process for handling product complaints and reporting adverse events did not meet the HSA's stringent 24-hour reporting timeline, a minor detail that brought their entire market entry strategy to a halt and required a complete overhaul of their quality agreement. This episode will help you answer: - Why is my existing ISO 13485 certification not enough to pass a Singaporean GDPMDS audit? - What are the most common and costly mistakes foreign MedTech companies make when implementing SS 620? - How can I ensure my entire supply chain, from freight forwarder to the final warehouse, is fully compliant? - What are the specific requirements for device traceability and recall readiness that HSA auditors focus on? - How does a local, in-country representative de-risk my market entry and interactions with the HSA? - What are the critical differences in handling temperature-sensitive devices versus general medical devices under GDPMDS? - How can modern AI and data tools accelerate the documentation and submission process for certification? - Is it more cost-effective in the long run to hire a specialized consultant or build an in-house team for this? To ensure your successful entry into the Singaporean market, contact our experts at [email protected] or visit us at https://pureglobal.com/.