THE Ministry of Health is advising the population that before the actual importation of any rapid antigen or antibody test kits into the country, an application together with supporting documents and a sample of the product, must be submitted to the Chemistry, Food and Drugs Division (CFDD) for an assessment and issuance of a “No Objection” letter.
The Ministry in an advisory issued on Friday stated that under the Food and Drugs Act, Chapter 30:01, the term “device” referred to any instrument, apparatus or contrivance, including components, parts and accessories, manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or the symptoms thereof, in man or animal.
Rapid antigen or antibody test kits fall within this definition.
To process the application for the Issuance of a “No Objection” for the importation of devices, persons must submit an application for a “No Objection” letter requesting permission to import devices with relevant supporting documents to CFDD. The application will be processed by CFDD to determine compliance with the Food and Drugs Act. The applicant will be notified as to whether the application has been accepted (“No Objection” letter is issued) or rejected.
The ministry stated, “The public is asked to note that a ‘No Objection’ status can be amended based on new data and information arising with respect to the safety or quality of the test kit. The public is further asked to note that where a rapid antigen or antibody test kit is imported into the country without the relevant approvals by the CFDD, that individual may be liable to a fine and or imprisonment under the Food and Drugs Act.”
The public is being further advised that the Ministry of Health recommends that the Polymerase Chain Reaction (RT-PCR) remains the internationally accepted confirmatory test for SARS-CoV-2 (Covid-19) detection and diagnosis.
Importers, healthcare providers and the public are cautioned about the limitations in using rapid antigen or antibody test kits as the sole basis for diagnosing patients for the Covid-19 virus.
The public is encouraged to immediately report cases of misleading or deceptive labels and advertisements, which may create an erroneous impression regarding the character, value, composition, merit or safety of a Test Kit to the Chemistry Food and Drugs Division at cfdd.health.gov.tt or 868-623-5242.
