Regulatory services for IVD reagents-Bangladesh
According to the Drug and cosmetics act, 2023, IVD reagents, instruments and analyzers are under the jurisdiction of Directorate General of Drug Administration, Bangladesh. IVD reagents are classified as Class A, B, C and D in the medical device guideline of Bangladesh. DGDA is the regulatory authority for the IVD reagents and rapid test kits. Directorate General of Drug Administration (DGDA) is the licensing authority for Medical device, Pharmaceuticals, IVD reagents, rapid test kits, medical equipment and medicated cosmetics manufactured or sold in Bangladesh. Pharma DRA provides the regulatory intelligence service, gap analysis service, documents review and registration service for IVD reagents importation. Rapid test kits are also regulated by DGDA, hence registration of rapid test kits is mandatory. All these products regulation and control are under the jurisdiction of DGDA Bangladesh.
Timeline to get the registration certificate: 4 – 6 months.
Registration validity: 5 years
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