Decoding SS GDPMDS Requirements (GN-33 Revision 2): What Importers, Wholesalers & Service Providers Need to Know

The latest GN-33 Revision 2 (September 2023) brings greater clarity to Singapore’s Standard for Good Distribution Practice for Medical Devices (SS GDPMDS) Requirements. If your organisation imports, distributes, or provides outsourced services for medical devices, here’s a streamlined breakdown of the key compliance expectations.

SS GDPMDS Requirements Explained

1. Strengthened Storage & Stock Handling Controls

Ensuring the physical integrity of medical devices remains a core requirement.

• Proper Storage Conditions: Facilities must provide adequate security and protection from contamination, deterioration, heat, and direct sunlight.

• Mandatory Segregation: Clear physical separation is required for quarantined, saleable, expired, rejected/damaged, recalled, and returned devices. Alternative segregation is allowed only if the method can prevent mix-ups.

• Effective Stock Rotation:

  • FEFO for devices with expiry dates

  • FIFO for those without expiry dates

• Pest Management: Storage areas must be protected against pests, with documented pest-control records maintained.

2. Clear Definitions for Secondary Assembly

Revision 2 clarifies what qualifies as Secondary Assembly versus Manufacturing.

• Secondary Assembly Defined: Repacking devices without breaching primary packaging by placing them into another container for supply.

• Not Considered Secondary Assembly:

  • Sterilization

  • Assigning new expiry dates

  • Changing brand or product owner name

  • Modifying primary labels

• Required Controls:

  • Line Clearance: Documented checks before each new batch

  • Traceability: Batch/lot tracking of every device repackaged

3. Enhanced Cold Chain Management (Annex C)

For devices stored at 8°C or below, more stringent controls apply:

• Temperature Mapping: Initial mapping to identify hot and cold zones

• Continuous Monitoring: Continuous temperature logs with alarms for excursions

• Backup Power: Generators or validated contingency plans

• Temperature-Controlled Delivery: Insulated packaging with loggers or validated configurations

4. Quality Management & Documentation SS GDPMDS Requirements (GN-33 Revision 2) Expectations

Compliance hinges on robust, well-maintained documentation.

• Record Retention: Keep records for the device’s projected useful life or 2 years from supply/disposal—whichever is longer. Internal audit records must be retained for 3 years.

• Electronic Systems: Must include audit trails and access controls.

• Site Master File: Prepare according to HSA’s GN-03 requirements.

5. Post-Market Duties & Regulatory Reporting

Dealers must stay proactive in monitoring product performance and safety.

• Counterfeit/Tampered Devices: Quarantine immediately and report using the Medical Device Post-Market Information Report.

• FSCA Requirements: Notify HSA before initiating any Field Safety Corrective Action.

• Complaint Handling: Establish a formal complaint process; adverse events must be reported per GN-05.

6. Oversight of Outsourced Activities

Companies remain responsible even when activities are outsourced.

• Service Provider Audits: Outsourced providers must be audited by your certification body unless they hold valid SS GDPMDS certification.

• Contracts: Written agreements must clearly define roles, responsibilities, and technical requirements like storage conditions.

Conclusion

SS GDPMDS Requirements (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.