MoH issues guidelines for importation of rapid antigen/antibody test kits


    The Health Ministry has issued general guidelines for the importation of rapid antigen/antibody test kits to be sold to the public.

    It says before the actual importation, an application with supporting documents and a sample of the product, must be submitted to the Chemistry, Food and Drugs Division for an assessment and issuance of a “No Objection” letter.

    The process is 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.

    The Ministry adds 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.

    It also issued a list of 25 Rapid Antigen/Antibody Test Kits that have received the “No Objection” for importation into the country.

    In this regard, it says an application is required for each importation.

    Persons should also note that where a Rapid Antigen/Antibody Test Kit is imported without the relevant approvals, that individual may be liable to a fine and/ or imprisonment under the Food and Drugs Act.

    The Ministry also again emphasizes that PCR tests remain the internationally accepted confirmatory test for COVID-19 detection and diagnosis.

    Persons are also 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 or 868-623-5242.