COVID-19 Test Kit Pre-approval Process

The WHO (2020) has stated that it has received multiple reports regarding falsified in vitro diagnostics and laboratory reagents for the detection of the virus, SARS-CoV-2.

The purpose of this pre-approval process is to prevent the importation of such falsified products.

All PCR and antigen test kit imports must apply for pre-approval via this form.

Reference: WHO. 2020. Medical Product Alert No3/2020 Falsified medical products, including in vitro diagnostics, that claim to prevent, detect, treat or cure COVID-19. Ref RPQ/REG/ISF/Alert No3.2020.
First Name
Last Name
Email
Phone Number
Are you importing this for business or personal use?
Business Name
BHEC Number
Intent for use
Manufacturer
Kit name and description
Product Code
Has this product been authorized for Emergency Use by an international regulatory authority?
Has this product been authorized for use by the FDA or MHRA?
Please note that by selecting "No" your submission will automatically be denied.
Quantity of Kits
Which country has approved the use of this product?
Shipment Details
Is shipment arriving as Passenger Baggage?
Bill of Landing Number / Air Waybill Number / Tracking Number
Vessel / Air Craft name
Vessel / Air Craft number
Date of Arrival (scheduled or actual)
Day - Month - Year

Shipment Details