Achieve SS 620 GDPMDS Certification in Singapore for Medical Device Distribution
Medical devices demand strict quality and safety controls. The Good Distribution Practice for Medical Devices (GDPMDS) certification is a requirement in Singapore for companies importing, storing, or distributing medical devices. At ISOGuruSG, we help you simplify GDPMDS compliance with step-by-step guidance, tailored documentation, and audit preparation — ensuring you meet Health Sciences Authority (HSA) licensing requirements with confidence.
What Is SS 620 GDPMDS and Why It Matters
SS 620 GDPMDS is a quality management system specific to the distribution of medical devices in Singapore. It ensures that devices are consistently stored, handled, and delivered in a way that maintains product safety and effectiveness. Certification is mandatory for HSA licensing, meaning companies cannot legally operate without it. Beyond compliance, SS 620 GDPMDS builds confidence with healthcare providers, regulators, and patients by demonstrating commitment to quality and safety.
Common Challenges Singapore Companies Face With SS 620 GDPMDS
Businesses pursuing SS 620 GDPMDS often struggle with documentation, risk management, and staff training. Smaller distributors may lack structured SOPs, while larger companies face challenges aligning multiple warehouses or logistics partners with SS 620 GDPMDS requirements. Temperature control, traceability, and record-keeping are also common problem areas. Without proper guidance, companies risk non-compliance, delays in licensing, and costly re-audits.
How We Help You Prepare for SS620 GPDMDS Certification Audits
Our consultancy covers every step of SS 620 GDPMDS certification. We help you draft SOPs, establish quality controls, and implement training programmes tailored to your team. We also conduct mock audits to ensure readiness for both the certification body and the HSA’s inspection. With ISOGuruSG, you will walk into audits fully prepared, confident that your processes and records meet the highest standards.