Guidelines for the Importation of Rapid Antigen/Antibody Test Kits

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.

Under the Food and Drugs Act, Chapter 30:01, the term “device” refers to any instrument, apparatus or contrivance, including components, parts and accessories thereof, 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/ Antibody Test Kits fall within this definition.

Process for the Application for the Issuance of a “No Objection” for the importation of Devices are as follows:

1. Submit an application for a “No Objection” letter requesting permission to import Devices with relevant supporting documents to CFDD.

2. Application will be processed by CFDD to determine compliance with the Food and Drugs Act.

3. The applicant will be notified as to whether the application has been accepted (“No Objection” letter is issued) or rejected.

Further information regarding the application process may be obtained from the Chemistry Food and Drugs Division at cfdd.health.gov.tt or 868-623-5242.

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 table below lists the Rapid Antigen/Antibody Test Kits that have received the CFDD's “No Objection” for importation into the country. In this regard, an application is required for each importation.

The public is further asked to note that where a Rapid Antigen/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 advised that the MoH 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 therefore cautioned about the limitations in using Rapid Antigen/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.

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