ISO 13485 (Clause 8.2) -Singapore Vigilance and Reporting to the Regulatory Authorities

Maintain compliance with Singapore’s regulatory requirements for medical devices using our ISO 13485:2016 Clause 8.2 Singapore Vigilance and Reporting to the Regulatory Authorities Procedure Template. Post-market vigilance and adverse event reporting are essential for ensuring the safety and effectiveness of medical devices in the Singapore market. This ready-to-use template provides a structured approach for monitoring product performance, handling adverse events, and reporting incidents to the Health Sciences Authority (HSA), ensuring your organization remains compliant with Singapore’s Medical Device Regulations.

✔ Pre-Formatted Vigilance & Reporting Procedure – Fully aligned with ISO 13485:2016 Clause 8.2 and HSA regulations.
✔ Incident Detection & Evaluation – Define procedures for identifying and evaluating adverse events, device failures, or safety concerns.
✔ HSA Reporting Requirements – Ensure timely and accurate reporting of incidents to the Health Sciences Authority per Singapore's regulatory guidelines.
✔ Corrective & Preventive Actions (CAPA) – Document corrective actions and preventive measures to mitigate risks and ensure product safety.
✔ Audit-Ready Documentation – Keep detailed records for regulatory inspections and internal audits.
✔ Editable Digital Format – Customizable for various medical device types and HSA reporting protocols.

This vigilance and reporting procedure template is ideal for regulatory affairs teams, quality managers, and compliance officers, ensuring efficient compliance with Singapore’s medical device regulations.

Download the ISO 13485:2016 Singapore Vigilance and Reporting Procedure Template today and enhance your post-market surveillance and regulatory reporting processes!