Quality Management System (QMS) for Medical Devices

The specific roles and responsibilities of various parties in the QMS for Medical Devices are as below:

Singapore Accreditation Council (SAC)

• Accredits certification bodies (CBs) for the Good Distribution Practice for Medical Devices (GDPMDS) and Medical Device QMS schemes in accordance with ISO/IEC 17021-1, SAC CT 04, and SAC CT 18.

• Conducts office assessments and witness assessments (WAs) of accredited CBs (ACBs) to verify ongoing compliance with accreditation requirements.

Health Sciences Authority (HSA)

• Conducts WAs on ACBs to ensure that QMS technical and regulatory requirements are consistently applied.

The types of QMS standards for medical devices are:

• 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 ACBs by the SAC is required. Alternatively, Medical Device Single Audit Program (MDSAP) certification may be submitted. The QMS certificate, together with the audit report, should be submitted.

• For Class A medical devices only, a Declaration of Conformity to ISO 13485 may be submitted in lieu of certification by an 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 ACBs by the SAC is required. Alternatively, MDSAP certification may be submitted. The QMS certificate, together with the audit report, should 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 ACB.

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.