Conducting Clinical Trials for Medical Devices in Singapore

1. Overview

Clinical trials involving medical devices in Singapore are regulated by the Health Sciences Authority (HSA) under the Health Products Act. Most trials require prior approval from HSA, except for certain low-risk or observational studies that may be exempt or subject to notification only. The objective is to ensure participant safety, scientific validity, and ethical conduct. Source: https://www.hsa.gov.sg/medical-devices/clinical-trials

2. When Approval is Required

HSA approval is mandatory for clinical trials that:

• Involve the use of an unregistered medical device.
• Are interventional (assign participants to receive specific interventions).
• Pose more than minimal risk to participants.

Exemptions or simplified requirements may apply to:

• Low-risk devices (e.g., certain Class A/B devices with established safety profile).
• Observational studies without intervention.
• Trials using CE-marked or FDA-approved devices under specific conditions.

Source: https://www.hsa.gov.sg/medical-devices/clinical-trials

3. Key Requirements for Approval

To obtain HSA approval, applicants must submit:

• Clinical trial protocol.
• Investigator's brochure or device information.
• Ethics committee approval letter from a recognised ethics committee.
• Evidence of investigator qualifications and site suitability.
• Insurance/indemnity arrangements for trial participants.
• Risk-benefit assessment and safety monitoring plan.

Trials must comply with international standards such as ISO 14155 (Good Clinical Practice for Medical Devices). Source: https://www.hsa.gov.sg/medical-devices/clinical-trials

4. Application Process

• Submit applications electronically via the HSA online portal (PRISM system).
• Processing time is typically 30 working days for standard applications.
• HSA may request additional information or clarifications during review.
• Once approved, the trial is assigned a Clinical Trial Reference Number.

Source: https://www.hsa.gov.sg/medical-devices/clinical-trials

5. Responsibilities During the Trial

• Sponsor must ensure ongoing safety monitoring and prompt reporting of serious adverse events.
• Investigators must adhere to the approved protocol and obtain informed consent.
• Amendments to protocol, investigator, or site require prior HSA approval.
• Annual progress reports and final study reports must be submitted.

Source: https://www.hsa.gov.sg/medical-devices/clinical-trials

6. Post-Trial Requirements

• Submit a final study report to HSA upon trial completion.
• Report any findings that may impact device safety or performance.
• Retain trial records for at least 10 years (or longer if required).

Source: https://www.hsa.gov.sg/medical-devices/clinical-trials

7. Important Notes

• All clinical trials must be conducted in accordance with ethical principles (e.g., Declaration of Helsinki).
• Non-compliance may result in suspension, termination, or regulatory action.
• Last updated: 31 Dec 2018. Source: https://www.hsa.gov.sg/medical-devices/clinical-trials