Import applications increase… Food and Drug Dept. clamps down on COVID-19 testing kits, reagents

Apr 23, 2020 News

The authorities are getting tough on importation of supplies to fight the COVID-19 pandemic.

The WHO has to date 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.

In recent days there has been a marked increase in applications for testing strips, among other things.
According to the head of the Government Analyst-Food and Drug Department (GA-FDD), Dr. Marlan Cole, there are strict requirements for the import of medical devices, particularly in vitro diagnostic (IVDs) test kits and laboratory reagents.
“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,” the regulator said yesterday.
The department said that the importers and distributors are mandated to do a number of things before devices and kits are released for sale or use in the health-care delivery system:
“Importers/Distributors must be registered with the GA-FDD as an importer and obtain a permit to import medical devices (IVDs- Kits and laboratory reagents).”
An import license and Customs entry must be submitted to the department for approval and release.
According to the regulator, importers and distributors must demonstrate that medical devices are manufactured according to the International Standard Organization (ISO) 13485:2016 Standard.
“Importers/Distributors must demonstrate to the department by way of a free sale certificate (FSC) that the medical device (in vitro diagnostic test kits

GA-FDD says that it will only allow approved test kits into the country.

and laboratory reagent) is freely sold and used in the country of origin.”
According to GA-FDD, the importer and distributor must also demonstrate to the department that the company or individual is in possession of a manufacturer’s or distributor’s authorization from the manufacturer or a distributor.
Meanwhile, the department is warning that it has observed an increase in applicants and requests for the importation of medical devices (IVDs test kits and laboratory reagents) in response to the COVID-19 pandemic.
“The World Health Organization (WHO), however, has to date 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 said it will 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.
Those countries are Australia, Brazil, Canada, People’s Republic of China, Russian Federation, Singapore, 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), none has been approved or validated by the WHO as a result of several challenges associated with sensitivity and specificity.”
The GA-FDD said 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.

Dr. Marlan Cole, Head of GA-FDD

“The Department is therefore warning consumers, healthcare professionals, public and private health care providers, of a growing number of falsified medical products that claim to prevent, detect, treat or cure COVID-19.”
In fact, the department said, the WHO, on 31st March, 2020, issued Medical Product Alert No 3/2020 on this issue.
(See full alert. https://www.who.int/news-room/detail/31-03-2020-medical-product-alert-n-3-2020).
“The GA-FDD wishes to also reiterate 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.”
Guyana is currently on a partial lockdown with 67 cases of COVID-19 and seven deaths confirmed so far.
Schools, the airports and borders remain closed with a countrywide night-time curfew in place.