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.
The Department says it will only facilitate the importation of test kits that utilize the RT-PCR method from the eight countries which have been listed by the WHO to produce IVDs test kits and laboratory reagents for the COVID-19 diagnosis. These 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.
With regards to Rapid Diagnostic Tests (RDTs) that are either serological (blood –antibodies) or antigen-based (viral proteins), the Department states that none has been approved or validated by the WHO as a result of several challenges associated with sensitivity and specificity. Therefore, the GA-FDD asserts that it will 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.
The Department also issued a warning to consumers, healthcare professionals, public and private health care providers to be on the lookout for a growing number of falsified medical products that claim to prevent, detect, treat or cure COVID-19. The WHO, it informs, had issued a Medical Product Alert No 3/2020 on March 31with regard to this issue.
Those persons wishing to review the alert in its entirety can do so at https://www.who.int/news-room/detail/31-03-2020-medical-product-alert-n-3-2020.
The GA-FDD also reiterated the need for importers and distributors to follow the respective guidelines and exercise caution to avoid undue issues or delays and to aid in the fight against this pandemic, the release added.
