SS 620 GDPMDS Consultancy Singapore: Secure Your Mandatory HSA License
For medical device distributors in Singapore, SS 620 GDPMDS (Good Distribution Practice for Medical Devices) is not optional. It's the mandatory Singapore Standard required by the Health Sciences Authority (HSA) for your dealer's license. Non-compliance risks license suspension, costly recalls, and irreparable damage to your reputation.
At ISOGuruSG, we specialize in this critical regulation. We combine authoritative knowledge of SS 620 GDPMDS with practical experience in Singapore's supply chain. Our proven framework ensures your operations—from warehouse management and cold-chain logistics to documentation and recall procedures—are fully compliant and HSA audit-ready.
Why SS 620 GDPMDS Compliance is Your Legal Foundation
Implementing a GDPMDS-compliant Quality Management System is a fundamental legal and operational requirement.
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Secure & Maintain Your HSA License: Full compliance is mandatory for obtaining, renewing, or upgrading any HSA license for importing, exporting, or wholesaling medical devices. It is your license to operate.
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Guarantee Patient Safety & Product Integrity: The standard safeguards the supply chain, ensuring life-saving devices are stored, handled, and transported under conditions that preserve their safety, quality, and efficacy.
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Mitigate Severe Regulatory & Financial Risk: Proactively avoid devastating license suspensions, product seizures, regulatory fines, and costly recall events with a robust, documented system.
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Build Unshakeable Trust with Partners: Certification demonstrates to global manufacturers and healthcare providers that you are a reliable, compliant partner, unlocking exclusive distribution agreements and tender opportunities.
Frequently Asked Questions: SS 620 GDPMDS in Singapore
What is SS620:2016 GDPMDS?
SS620:2016 is the Singapore Standard for Good Distribution Practice for Medical Devices. It is a mandatory requirement by the Health Sciences Authority (HSA) for companies involved in importing, wholesaling, and distributing medical devices.
Who needs GDPMDS certification?
Any company in Singapore that wishes to apply for an HSA Importer or Wholesaler License must first obtain SS620 GDPMDS certification from an accredited certification body.
How does ISOGuruSG help with SS620?
FWe provide a 100% first-time audit pass guarantee. Our approach includes lean documentation, zero jargon, and full support through the gap analysis, system implementation, and final audit phases.
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.
Take the decisive step towards guaranteed compliance. Read our free resources.
Contact ISOGuruSG today. Let us help you secure your HSA license, fortify your supply chain, and build a reputation as Singapore's most reliable medical device distributor.