Govt restricts imports of COVID-19 testing kits

…only those from WHO approved countries or “a serious reference authority” allowed

The Government Analyst-Food and Drug Department (GA-FDD) said that it would only be permitting reagents and testing kits approved by the World Health Organisation (WHO) or “a serious reference authority”.

The announcement was made by Director of the Food and Drug Department, Marlon Cole, who in publicising the restrictions said the agency has “observed an increase in applicants and requests for the importation of medical devices in response to the COVID-19 pandemic”.
He noted. however, to date only the use of the Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) as a test method has been approved for the identification and laboratory confirmation of the COVID-19 diagnosis.
As such, the Department will only facilitate the importation of test kits that utilise the RT-PCR method from the eight countries, which have been listed by the WHO to produce in vitro diagnostics (IVDs) test kits and laboratory reagents for the COVID-19 diagnosis.

Those countries are Australia, Brazil, Canada, the People’s Republic of China, the Russian Federation, Singapore, the Republic of Korea, and the United States of America.
It was noted that with regard to the Rapid Diagnostic Tests (RDTs) that are either serological (blood-antibodies) or antigen-based, none has been approved or validated by the WHO as a result of several challenges associated with sensitivity and specificity.
Accordingly, Cole said the GA-FDD would only approve the use and facilitate the import of RDTs for COVID-19 diagnosis which have been approved and validated by the WHO or a serious reference authority.
Additionally, importers must be registered with the GA-FDD as an importer and obtain a permit to import medical devices.
According to Cole, importers or distributors must demonstrate that the medical devices being imported are manufactured according to the required International Standard Organisation (ISO) Standard in addition to having a Free Sale Certificate (FSC) that the medical device is freely sold and used in the country of origin.
The Administration last month had announced the waiver of Value-Added Tax (VAT) on medical supplies being imported to combat the pandemic.
The Guyana Revenue Authority last month said that the Government of Guyana has zero-rated the VAT on all medical supplies for the testing, prevention and treatment of COVID-19 for the period March 26, 2020 to June 30, 2020.
The list includes test kits, protective garments, thermometers, disinfectants, patient-monitoring devices, medical ventilators, rubbing alcohol, Vitamin C tablets, and soaps.
Businesses were also asked to immediately cease charging VAT for these supplies.