SS 620 certification, also known as Good Distribution Practice for Medical Devices (GDPMDS), is a critical requirement for companies involved in the import, storage, distribution, delivery, installation, servicing, or secondary assembly of medical devices in Singapore. Issued by Enterprise Singapore and recognised by the Health Sciences Authority (HSA), SS 620 ensures that medical devices are handled in a way that preserves their safety, quality, and performance throughout the supply chain.
For medical device companies operating in Singapore, SS 620 is more than a certification—it is a demonstration that your distribution practices meet local regulatory expectations and are aligned with internationally accepted quality principles.
Our SS 620 certification and consulting services are designed to help medical device businesses achieve compliance efficiently, without unnecessary complexity or operational disruption.
What Is SS 620 (GDPMDS)?
SS 620 is Singapore’s national standard for Good Distribution Practice for Medical Devices. It applies to organisations that do not manufacture medical devices but are responsible for how devices are stored, transported, supplied, installed, or serviced after manufacturing.
The standard focuses on process control, traceability, risk management, and documented procedures across distribution activities. Its goal is to ensure that medical devices reaching healthcare providers and patients remain compliant with manufacturer specifications and regulatory requirements.
SS 620 is often required or strongly expected by:
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HSA during licensing or inspections
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Principals and manufacturers appointing local distributors
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Hospitals and healthcare procurement teams
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International partners assessing Singapore distribution compliance
Who Needs SS 620 Certification in Singapore?
SS 620 certification applies to a wide range of medical device businesses, including:
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Medical device importers and distributors
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Third-party logistics providers handling medical devices
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Warehousing and cold-chain storage providers
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Companies involved in installation, servicing, or maintenance
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Businesses performing secondary assembly, relabelling, or kitting
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Local authorised representatives managing distribution activities
If your organisation touches medical devices after manufacturing and before end use, SS 620 is highly relevant to your operations.
Why SS 620 Certification Matters
SS 620 certification provides both regulatory and commercial value. It helps organisations demonstrate control, reliability, and readiness in a tightly regulated healthcare environment.
Key benefits include:
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Alignment with HSA expectations for medical device distribution
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Improved control over storage, transport, and handling risks
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Stronger traceability for recalls, complaints, and adverse events
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Increased trust with principals, hospitals, and healthcare buyers
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Reduced risk of non-compliance during audits or inspections
For many companies, SS 620 also becomes a competitive requirement, not just a compliance one.
Our SS 620 Certification & Consulting Services
We provide end-to-end SS 620 consulting, supporting your organisation from initial assessment through certification and beyond. Our approach is practical, structured, and aligned with how medical device businesses actually operate.
1. SS 620 Gap Assessment
We begin with a detailed review of your current operations against SS 620 requirements. This includes:
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Distribution and storage processes
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Transport and delivery controls
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Complaint handling and recall readiness
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Documentation and record-keeping practices
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Training and competency management
You receive a clear gap report highlighting what is compliant, what needs improvement, and what is missing.
2. Scope Definition & Certification Planning
SS 620 compliance depends heavily on scope clarity. We help define:
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Which activities fall under SS 620
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Which sites, warehouses, and processes are in scope
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How responsibilities are allocated across teams and partners
This ensures your certification effort is accurate, defensible, and audit-ready.
3. Documentation & SOP Development
Documentation is a core requirement of SS 620, but it must reflect real operations. We support the creation and alignment of:
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Distribution and storage SOPs
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Transport and temperature control procedures
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Handling of non-conforming products
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Complaint management and recall procedures
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Record retention and traceability systems
All documents are tailored to your business model, not generic templates.
4. Implementation Support & Staff Training
We help your team put procedures into practice, ensuring SS 620 compliance is embedded into daily operations.
Support includes:
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On-site or remote implementation guidance
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Staff training on SS 620 roles and responsibilities
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Practical explanations of audit expectations
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Alignment between SOPs and actual workflows
This step reduces the risk of “paper compliance” failing during audits.
5. Internal Audit & Certification Readiness
Before the certification audit, we conduct an internal audit aligned with SS 620 clauses. This helps:
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Identify residual gaps or weak areas
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Prepare staff for auditor questions
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Strengthen evidence and records
We then support coordination with an accredited certification body and assist during the external audit process.
6. Post-Certification Support & Maintenance
SS 620 is not a one-time exercise. We continue to support organisations with:
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Surveillance audit preparation
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Change management for new products or processes
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Corrective action support
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Ongoing compliance improvements
Why Choose Us for SS 620 Consulting?
Our consulting approach is built specifically for medical device distribution businesses, not generic ISO certification.
What sets us apart:
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Deep understanding of GDPMDS and HSA expectations
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Practical, audit-focused consulting (not academic theory)
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SOPs and controls tailored to your real operations
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Experience across importers, distributors, logistics, and service providers
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Clear timelines, realistic effort, and no unnecessary paperwork
We focus on helping you pass audits confidently while improving operational control.
Frequently Asked Questions
Who needs SS 620 certification in Singapore?
SS 620 applies to companies that import, store, distribute, transport, install, service, or perform secondary assembly of medical devices in Singapore, ensuring product quality, traceability, and regulatory compliance requirements standards.
How long does SS 620 certification take?
Certification typically takes eight to sixteen weeks, depending on business size, scope, and readiness, including gap assessment, documentation, implementation, internal audit, and coordination with an accredited certification body for approval.
Is SS 620 certification mandatory in Singapore?
SS 620 certification is not legally mandatory, but it is strongly expected by HSA, principals, and healthcare customers, and often required to demonstrate compliant medical device distribution practices in Singapore.
Can small medical device companies get SS 620 certified?
Yes, small and medium-sized medical device distributors can achieve SS 620 by defining a clear scope, scaling procedures appropriately, and implementing practical controls suited to their operations and business size.
What happens after SS 620 certification?
After certification, organisations must maintain SS 620 through regular internal audits, staff training, record updates, change management, and surveillance audits conducted by the certification body to ensure continued compliance status.