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September 16, 2025
Approximately 5 minutes
Singapore's GDPMDS: The Mandatory QMS for Medical Device Distribution
Singapore's GDPMDS: The Mandatory QMS for Medical Device Distribution
The Good Distribution Practice for Medical Devices – Requirements (GDPMDS) is a mandatory Quality Management System (QMS) standard in Singapore that governs the distribution and supply chain activities for medical devices and In Vitro Diagnostic (IVD) devices.
GDPMDS is formalized under the national standard SS 620: 2016 and is administered by the Health Sciences Authority (HSA). Compliance is the essential first step required before a company can apply for a Medical Device Dealer’s License.
Scope and Applicability
- Applicable Entities: GDPMDS is mandatory for all local companies operating in Singapore that perform the following activities:
- Importers of medical devices and IVDs.
- Wholesalers (distributors) of medical devices and IVDs.
- Purpose: To ensure the quality, integrity, and traceability of medical devices during all stages of handling, storage, delivery, installation, servicing, and secondary assembly.
Key GDPMDS Requirements
To achieve compliance, companies must implement a QMS that meets the SS GDPMDS requirements, tailored to their distribution activities and device risk profile. Key requirements include:
| Requirement Area | Practical Implementation |
|---|---|
| Storage and Transport | Defined conditions, environmental monitoring, and segregated zones for all stock types (quarantined, saleable, rejected, recalled). Cold chain devices require special handling. |
| Traceability & Recall | Procedures to trace devices by batch/lot number and execute efficient recalls or Field Safety Actions. |
| Document Control | Controlled Standard Operating Procedures (SOPs), logs, and defined record-retention periods. |
| Non-Conforming Products | Defined procedures for complaint handling, investigation, returns, and physical segregation of rejected devices. |
| Personnel & Training | Clear responsibilities and documented training to ensure staff competency in GDPMDS-controlled activities. |
| Supplier/Subcontractor | Qualification and ongoing oversight of outsourced services like logistics providers and warehouses. |
GDPMDS Certification and Dealer’s License
1. GDPMDS Certification
- Process: After the QMS is implemented, the system must undergo an audit by a third-party Certification Body (CB) accredited by the Singapore Accreditation Council (SAC).
- Validity: The initial certification is valid for 3 years and requires annual surveillance audits to maintain its status.
- Equivalency: The HSA may accept equivalent certifications like ISO 13485 or MDSAP in place of SS GDPMDS certification for the purposes of licensing.
2. Medical Device Dealer’s License
- Prerequisite: The HSA will only grant a Medical Device Dealer’s License (authorizing import and/or wholesale) after the applicant company has obtained GDPMDS certification (or an accepted equivalent).
- Authorization: The license is issued by the HSA and is specific to the legal entity, authorizing commercial operations for regulated medical devices in Singapore.
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