SS 620 Good Distribution Practice for Medical Devices (GDPMDS) is the Singapore standard that specifies quality management system requirements for organizations involved in the storage, handling, transportation and distribution of medical devices. An accredited GDPMDS certificate is an accepted quality management system document for an HSA medical device dealer license.
SS 620 Good Distribution Practice for Medical Devices (GDPMDS) specifies the requirements for a quality management system covering the distribution of medical devices in Singapore. It applies to organizations involved with the import, wholesale, distribution, storage, warehousing, transportation and logistics of medical devices.
SS 620 certification helps ensure medical devices are stored, handled and distributed under controlled conditions, so they continue to meet the manufacturer’s specifications when they reach healthcare providers and patients. It demonstrates that an organization complies with Singapore Health Sciences Authority (HSA) requirements.
SGS provides a range of services to help you meet the requirements for certification.
Ensure the quality, safety and performance of your medical devices with SS 620/GDPMDS certification from SGS.
- Comply with Singapore’s medical device regulationsShow that your quality controls for the storage and distribution of medical devices are in line with HSA requirements.
- Demonstrate your commitment to patient safetyEnsure your medical devices remain safe and effective by the time they reach the patient.
- Improve quality management throughout the distribution processEstablish a structured, robust quality management system that covers the storage, transportation, handling and delivery of medical devices.
- Reduce operational and supply chain riskMinimize the risk of product damage, contamination, mix-ups or deterioration through defined storage and handling controls.
- Improve product traceabilityEnable faster and more effective recalls and corrective actions across the supply chain.
- Enhance brand reputationIncrease confidence in your brand among manufacturers, healthcare providers and consumers.
Why SGS?
As the world’s leading testing, inspection and certification organization, we have extensive experience in medical device certification. Our independent and impartial certification audits are delivered by experienced auditors with local knowledge of Singapore medical device regulations.
We provide comprehensive certification services for medical device wholesalers, distributors and logistics partners across a wide range of quality and regulatory standards. Our services also include customized GDPMDS training through SGS Academy. We will help you demonstrate your commitment to quality, safety and regulatory compliance.
FAQ
All medical device importers, wholesalers, distributors and dealers in Singapore should become certified.
SGS supports organizations seeking compliance with SS 620/GDPMDS through:
- Certification
- Surveillance audits
- Recertification audits
- Certification transfer
- Gap assessments
- Training
An SGS auditor will evaluate your quality management system, including storage controls, transportation, traceability, inventory management, personnel competency, complaint handling, product recall processes and processes for continual improvement.