Quality Management System (QMS) for Medical Devices
To ensure the safety, quality, and performance of medical devices, companies involved in manufacturing, importing, or distributing medical devices in Singapore must establish and maintain an appropriate Quality Management System (QMS) in accordance with regulatory requirements.
Last updated 13 March 2026
ISO 13485: Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
ISO 13485 is the internationally recognised standard that specifies requirements for a quality management system for the design, development, production, and distribution of medical devices.SS620: Good Distribution Practice for Medical Devices (GDPMDS) – Requirements
GDPMDS is a Singapore Standard that specifies requirements for a quality management system for companies involved in the distribution of medical devices to ensure product quality is maintained throughout the distribution process.
Manufacturers
Manufacturers of medical devices in Singapore must establish and maintain a QMS that conforms to ISO 13485.
When applying for a Manufacturer licence:
For Class B, C, or D medical devices, certification to ISO 13485 from Accredited Certification Bodies (ACBs) by the Singapore Accreditation Council (SAC) is required. Alternatively, Medical Device Single Audit Program (MDSAP) certification may be submitted.
For Class A medical devices only, a Declaration of Conformity to ISO 13485 may be submitted in lieu of certification by an accredited certification body (ACBs).
Importers and Wholesalers
Importers and wholesalers may adopt ISO 13485 or GDPMDS as their QMS.
When applying for an Importer or Wholesaler licence:
For Class B, C, or D medical devices, certification to GDPMDS or ISO 13485 from Accredited Certification Bodies (ACBs) by the Singapore Accreditation Council (SAC) is required. Alternatively, Medical Device Single Audit Program (MDSAP) certification may be submitted.
For Class A medical devices only, a Declaration of Conformity to ISO 13485 or GDPMDS may be submitted in lieu of certification by an accredited certification body (ACBs).
Common deficiencies identified during QMS audit
To enhance transparency and raise awareness of Quality Management Systems in the medical device industry, the Health Sciences Authority (HSA) has compiled deficiencies identified by accredited certification bodies during audits against GDPMDS and ISO 13485 standards.
By sharing these insights, HSA aims to promote continuous improvement and support industry compliance with quality management standards.
List of reports
Year | Report |
|---|---|
2024 |