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This application is a service of the Singapore Government.

Health Sciences Authority

Product Defect Reporting and Recall Procedures

defect_reporting

Defects in therapeutic products may occur at any point in the supply chain. Under the Health Products (Therapeutic Products) Regulations 2016, product defects that affects the safety, quality and efficacy and may cause potential harm to the patient or public health will have to be reported to the Health Sciences Authority (HSA).

Companies (product registrants, manufacturers, importers and suppliers) are responsible for the safety, quality and efficacy of their therapeutic products and should have adequate systems and appropriate procedures in place to investigate, review and report the product defects to HSA, and if necessary, to promptly recall the affected products.

 

When to report

Upon becoming aware of a defect with your therapeutic product, your company should gather the information necessary to assess the extent of the defect and the health risk posed to the intended users. The product defect must be reported, to allow HSA to assess the defect, determine if investigations into the root cause(s) of the defect are sufficient and whether the corrective actions taken are adequate and appropriate to mitigate the possible health risks to patients and consumers.

Every company who intends to recall a therapeutic product must notify HSA of, and the reasons for, the intended recall no later than 24 hours (excluding Sunday and public holidays) before the start of the intended recall.

Please refer to the Guidance for Industry- Reporting of Therapeutic Product Defects and Recall of Therapeutic Products and FAQs for the requirements on product defect reporting and product recalls. The purpose of the document is to provide guidance on reporting product defects (“defects”) and/or product recall (“recall”) of therapeutics product to the Vigilance and Compliance Branch of the Health Sciences Authority (HSA) in accordance with the Health Products Act (HPA) and Health Products (Therapeutic Products) Regulations 2016 (HP (TP) Regulations).

 

How to report

Company are advised to download the relevant reporting form below and submit the completed form and any other accompanying documents as specified in the guidance to: 

Vigilance and Compliance Branch

Email: hsa_productdefect@hsa.gov.sg

(Estimated time to complete form: 30 mins)

 

Contact Us

If you need further information regarding product defect reporting, please contact:

Vigilance and Compliance Branch

Tel: (65) 6866 1111

Email: hsa_productdefect@hsa.gov.sg