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Medical Device Auditors

What is a Medical Device Auditor?​

An HSA-recognised Medical Device Auditor is an independent auditor recognised by HSA to assess the Quality Management Systems of medical device dealer's licence applicants and holders in Singapore.

The auditor's role is to conduct an objective assessment of the company's QMS against the applicable requirements (ISO 13485 and HSA's licensing requirements) and to provide an audit report that forms part of the dealer's licence application.

Why auditors are required​

HSA does not conduct direct QMS inspections for every dealer's licence application. Instead, it relies on a system of recognised independent auditors to provide assurance of QMS quality before the licence is issued. This model is similar to the use of Notified Bodies in the EU or registered certification bodies in Japan.

Finding an HSA-recognised auditor​

The list of currently recognised Medical Device Auditors is maintained on the HSA website:

hsa.gov.sg/medical-devices/dealers-licence/medical-device-auditors

Always verify the auditor's current recognition status with HSA before engaging them.

The audit process​

  1. The company contacts and engages an HSA-recognised auditor.
  2. The auditor reviews the QMS documentation and conducts an on-site audit.
  3. The auditor identifies any non-conformances and gives the company an opportunity to resolve them.
  4. The auditor issues a final audit report.
  5. The company includes the audit report in its dealer's licence application to HSA.

Official sources​