Quality Assurance

Last Updated on April 28, 2022

Following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to the Quality Assurance and Import/Export of therapeutic goods.

1. Quality Assurance

Guidelines on Recalls and Rapid Alerts of Defective Therapeutic Goods
English ( 658 KB – PDF)

2. Import and Export of Therapeutic Goods

Guidelines on Import and Export of Therapeutic Goods
English ( 609 KB – PDF)

User Manual / Guide for Online Import Export Software (OIES)
English ( 724 KB – PDF)