Quality Management System Requirements for Medical Device Dealers in Singapore

1. Overview

Medical device dealers in Singapore are required to implement and maintain a Quality Management System (QMS) appropriate to their licensed activities (manufacturing, import, wholesale). The QMS ensures that devices are consistently produced and controlled to meet quality, safety, and performance requirements throughout the supply chain. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/quality-management-system-(qms)-for-medical-devices

2. QMS Requirements by Licence Type

Importer's Licence

• Good Distribution Practice for Medical Devices (GDPMDS) certification is required.
• Issued by a certification body accredited by the Singapore Accreditation Council (SAC).
• Scope must cover the import and distribution of medical devices.
• GDPMDS is based on ISO 13485 but tailored to distribution activities.

Wholesaler's Licence

• GDPMDS certification is required.
• Scope must cover wholesale supply, including export and distribution to other parties for re-supply.
• Same accreditation and scope requirements as for importers.

Manufacturer's Licence

• ISO 13485 certification is required for manufacturers.
• Scope must cover the design, development, manufacturing, and related activities for medical devices.
• MDSAP (Medical Device Single Audit Program) certification is also accepted as it aligns with ISO 13485 requirements.

Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/quality-management-system-(qms)-for-medical-devices

3. Certification Body Requirements

• Certification must be issued by a body accredited by the Singapore Accreditation Council (SAC) or equivalent international accreditation recognised by HSA.
• The certificate must clearly state the scope of certification and cover all relevant activities under the licence.
• For Class A devices only (low risk), a Declaration of Conformity to ISO 13485 or GDPMDS may be accepted in lieu of full certification in certain cases.

Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/quality-management-system-(qms)-for-medical-devices

4. Application and Renewal Implications

• QMS certification or declaration must be submitted during initial licence application, amendment, or renewal.
• Licence validity is linked to the QMS certificate expiry; dealers must ensure timely renewal of certification to avoid licence lapse.
• Changes to QMS certification (e.g., new certificate, updated scope, new certification body) require an amendment application via SHARE.

Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/quality-management-system-(qms)-for-medical-devices

5. Important Notes

• Non-compliance with QMS requirements may lead to regulatory action, including suspension or revocation of licence.
• Dealers must maintain records and undergo audits as required by their QMS standard.
• For outsourced activities (e.g., storage, distribution), the QMS scope must include oversight of outsourced providers.
• Last updated: 31 Dec 2018. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/quality-management-system-(qms)-for-medical-devices

6. Related Guidance

Refer to GN-02 Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices for detailed QMS expectations and acceptable standards. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/quality-management-system-(qms)-for-medical-devices