As a result of the increase in applications for the importation of medical devices (IVDs test kits and laboratory reagents) in response to the COVID-19 pandemic, the Government Analyst-Food and Drug Department (GA-FDD) has warned that only those with WHO approval will be allowed in.
In a GA-FDD release on Wednesday, it was noted that these requirements are in accordance with the laws of Guyana, Food and Drug Act Chapter 34:03 Part VI Section 32(2), the Food and Drug Regulations- Part VII Section 115(c) and those articulated in the GA-FDD Application Form for a Permit to Import Medical Devices.
Importers and distributors were urged to note that to date, the World Health Organization (WHO) has only approved the use of the Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test method for the identification and laboratory confirmation of the COVID-19 diagnosis.
