A Complete Guide to SS GDPMDS Requirements Based on GN-33 Revision 2 (September 2023)
The Singapore Standard for Good Distribution Practice for Medical Devices (SS GDPMDS) defines the quality and regulatory expectations for organisations handling medical devices within the supply chain. The latest update, GN-33 Revision 2 (September 2023), introduces clarified definitions and strengthened operational requirements to ensure safety, traceability, and compliance.
1. Storage and Stock Handling Requirements
The primary objective of SS GDPMDS storage controls is to preserve the physical integrity and safety of medical devices across all handling stages.
1.1 Storage Conditions
Facilities must provide:
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Protection against contamination and deterioration
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Control of excessive heat and direct sunlight
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Adequate security to prevent unauthorized access
1.2 Stock Segregation
Organisations must maintain clearly designated and physically separated zones for:
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Quarantined stock
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Saleable stock
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Expired stock
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Rejected or damaged stock
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Recalled stock
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Returned stock
Alternative segregation methods are acceptable only when they reliably prevent mix-ups.
1.3 Stock Rotation
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FEFO (First-Expiry-First-Out) applies to products that have expiry dates.
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FIFO (First-In-First-Out) applies to products without expiry dates.
1.4 Pest Control
Storage areas must prevent pest entry. Records such as pest-control service reports and bait-station maps must be retained for verification.
2. Clarified Requirements for Secondary Assembly
GN-33 Revision 2 provides explicit definitions to differentiate secondary assembly from manufacturing activities.
2.1 Definition of Secondary Assembly
Secondary assembly refers to placing medical devices—while still sealed in their primary packaging—into another container or packaging intended for supply.
2.2 Activities Not Considered Secondary Assembly
The following are classified as manufacturing and not secondary assembly:
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Sterilization
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Assigning new expiry dates
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Changing brand names or product owner names
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Modifying primary labels
2.3 Operational Controls for Secondary Assembly
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Line Clearance: Workstations must be checked and cleared of previous materials before each batch.
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Traceability: Batch and lot information must be recorded for every device repacked.
3. Cold Chain Management Requirements (Annex C)
Additional requirements apply to medical devices that must be stored at 8°C or below.
3.1 Temperature Mapping
Initial temperature mapping must be performed under representative operating conditions to identify hot and cold spots in storage areas.
3.2 Continuous Monitoring
Temperature must be continuously monitored and recorded. Alarm systems must be installed to detect and notify temperature excursions.
3.3 Backup Power Supply
Generators or validated contingency plans are required to maintain temperature in the event of a power failure.
3.4 Cold-Chain Transport
Devices must be transported using insulated materials with temperature loggers or through validated packing configurations.
4. Quality Management System and Documentation Requirements
A robust documentation framework is essential for demonstrating compliance with SS GDPMDS.
4.1 Record Retention
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Records must be retained for the device’s projected useful life or two years from the date of supply/disposal, whichever is longer.
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Internal audit records must be kept for three years.
4.2 Electronic Records
Electronic quality systems must provide:
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Secure audit trails
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Controls to prevent unauthorized data entry or modification
4.3 Site Master File
Organisations must maintain an up-to-date Site Master File prepared according to HSA Guidance GN-03.
5. Post-Market Responsibilities
Dealers must actively monitor product performance and manage safety-related issues.
5.1 Counterfeit, Tampered, or Adulterated Devices
Such devices must be quarantined immediately and reported using the Medical Device Post-Market Information Report Form.
5.2 Field Safety Corrective Actions (FSCA)
Organisations must notify the Health Sciences Authority (HSA) before initiating any FSCA, including product recalls.
5.3 Complaint Handling
A formal complaint-handling procedure is mandatory. Complaints involving adverse events must be reported in accordance with GN-05.
6. Requirements for Outsourced Activities
Organisations remain responsible for outsourced quality-related activities.
6.1 Service Provider Audits
Outsourced service providers must be audited by the organisation’s certification body unless the provider already holds a valid SS GDPMDS certification.
6.2 Contract Requirements
A written contract must define:
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Roles and responsibilities
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Technical specifications (such as required storage temperatures)
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Quality expectations for service delivery
7. Key Updates Introduced in GN-33 Revision 2
GN-33 Revision 2 includes two key enhancements:
7.1 Proactive User Feedback
Dealers are encouraged to seek and evaluate feedback from healthcare professionals, users, and patients to strengthen device safety.
7.2 Supplier Verification for Secondary Assembly
Devices used for secondary assembly should be sourced from approved suppliers—preferably manufacturers—and supported by Certificates of Analysis where applicable.
GN-33 Revision 2 reinforces the importance of traceability, quality control, and safety across the medical device supply chain in Singapore. Organisations handling storage, distribution, and secondary assembly must align their processes with these updated SS GDPMDS requirements to ensure regulatory compliance and uphold patient safety.
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