Product defect reporting and recall procedures for cell, tissue or gene therapy products (CTGTP)
Find out when and how to report or recall defective CTGTP that may potentially cause harm to patients or public health.
Last updated 23 March 2026
Overview
Product defect that affects the safety, quality and efficacy of the product, and may cause potential harm to the patient or public health, must be reported to HSA. A defective product is one that:
Has or has possibly been adulterated or tampered with.
Is or is possibly an unwholesome health product.
Is or is possibly of inadequate quality or unsafe or inefficacious for its intended purpose.
Fails or could possibly fail to satisfy such other standards or requirements as may be prescribed.
Product registrants, manufacturers, importers and suppliers are responsible for the safety, quality and efficacy of their products. They should have systems and procedures in place to investigate, review and report the product defects to HSA, and if necessary, to promptly recall affected products.
Classification of product defect
A defect is classified into either "critical defect" or "non-critical defect" according to the potential impact to public health and the risks posed to the intended user of the product.
Classifications of product defect
Critical defect | Non-critical defect |
|---|---|
A defect that can pose a serious threat to the intended users or public health in Singapore. A serious threat means a hazard that occurs in association with the use or administration of a product and that may lead to the death of, or a serious injury to, any person. | A defect which does not meet the criteria of “critical defect” but may cause illness or affect the outcome of a person’s medical treatment and/or affect the quality of a product. |
Product defect reporting and recall requirements
Report product defects
Find out about information required and guidelines to report product defects to HSA.
Recall products
Find out about information required, process and timelines to recall products.
Guide for the industry
Video guide on product defect reporting and recall in Singapore. This video brings you through the considerations on whether a product defect needs to be reported to us, and the steps to report the defect or recall the product.