Report adverse events

It is important to report adverse events associated with health products. Find out how to report them to HSA.

How to report

You are encouraged to report to us as soon as you are made aware of the adverse events, using one of the following methods:

Online submission

 Product types  Online reporting
All product types except vaccines and medical devices
 Vaccines

 

Manual submission

Complete the relevant form below and submit to us accordingly.

Product types Reporting forms

Therapeutic products (other than vaccines)

Therapeutic products (vaccines)
Medical devices
Complementary health products such as:
  • Chinese proprietary medicines
  • Traditional medicines
  • Health supplements
Cell, tissue and gene therapy products
Cosmetic products

 

Information on adverse event reporting

  • For healthcare professionals
    Find out how to report an adverse event to us and learn more about the reporting process for specific adverse events.
  • For therapeutic product companies
    All therapeutic product dealers, including importers, manufacturers, suppliers and registrants are required to report adverse events of their products.
  • For medical device companies
    All companies dealing in medical devices including importers, manufacturers, suppliers and registrants are required to report adverse events of their products.
  • For clinical trials
    The clinical trial sponsor is required to report adverse events involving therapeutic products, medicinal products and medical devices.

Adverse Event Online Database

You may access the HSA Adverse Event Online Database for information about suspected local adverse events of therapeutic products and medicinal products captured from reports submitted to us by healthcare professionals as well as companies.

  • Industry partners may access through the HSA AE Online Enquiry e-service.
  • Healthcare professionals may access through the Ministry of Health  website by following the steps below:
    1. Go to Healthcare Professionals Portal and choose your profession.
    2. Click on the "Restricted Content" icon on the left panel of web page and login via SingPass.
    3. Click on HSA-AE under e-services.

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