Due to the COVID-19 situation, TISI, FDA and NBTC adjusted current license issuing procedures. According to our sources at the agencies, steps were made to issue temporary licenses, until auditors will be able to inspect manufacturing facilities abroad.

TISI and NBTC auditors will be not allowed to travel abroad for factory inspections until the further notice. For all importers during this time, temporarily licenses will be issued for each product. For temporary licenses, local product testing will be required, but manufacturers will be exempt from factory inspections.

To ensure positive outcome of your application, Pro License Co., Ltd. recommend all importers to make sure they have required quality certificates for manufacturing facilities, such as ISO 9000 and product test reports.

Please make sure before contacting us that you have following documents for each product you want to import:

1. Assessment of the quality control system of the manufacturing facility, such as ISO 9000 certificates. This usually referred as an “Approval of the Premises”.
2. Product test report with the evaluation of product to be imported, also known as an “Approval of the Product”.