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)