Bangladesh IVD Registration: DGDA Regulation and Reference Country Requirements

Bangladesh IVD Registration: DGDA Regulation and Reference Country Requirements

The registration of In Vitro Diagnostic (IVD) devices in Bangladesh is regulated by the Directorate General of Drug Administration (DGDA), operating under the Ministry of Health. This framework was formalized by the Drugs and Cosmetics Act, 2023, which explicitly includes IVD reagents and software within its definition of a medical device.

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Classification and Validity

IVD devices are classified into four risk categories (A, B, C, D) following the principles of the ASEAN Medical Device Directive (MDD).

• Class A Licenses (Low Risk) do not expire.
• Class B, C, and D Licenses are valid for 5 years and are renewable.

The Mandatory Two-Step Registration Process

Applications for new Market Authorization Certificates for Class B, C, and D IVD devices are subject to a mandatory two-step review process by the DGDA, which typically takes 4–6 months to complete:

1. Primary Review (Recipe Approval)

The initial phase focuses on checking the completeness of all submitted technical and administrative documents. Upon successful review (3–4 months), the DGDA issues a 'Recipe Approval' letter.

2. Final Registration

This phase involves the full, in-depth review of the application and the submission of original, authenticated documents, including the Certificate of Free Sale (CFS) and ISO 13485.

Reference Country Documentation Requirements

The required documentation depends heavily on the device's risk class:

IVD Class	Risk Level	Required Documentation	Attestation Requirement
Class A/B	Low/Medium-Low	Certificate of Free Sale (CFS) from the Country of Origin.	Original CFS must be attested by the Bangladesh Embassy.
Class C/D	Medium-High/High	CFS and ISO 13485 Certificate from a Reference Country.	Both CFS and ISO 13485 must be attested by the Bangladesh Embassy.

Reference Countries accepted by the DGDA include the European Union (EU), the United States (USA), Canada, Japan, and Australia.

Local Representation and License Transfer

Foreign manufacturers are required to appoint a single Local Authorized Representative/License Holder to submit the application and hold the registration.

• Importing: The License Holder does not need to be the physical importer; the manufacturer can work directly with distributors for importation. However, the License Holder must issue a No Objection Certificate (NOC) for each importation.
• License Transfer: Transferring a license to a new License Holder is possible but requires the original registration certificate, which is typically held by the current License Holder. Without the original certificate, a new registration is necessary.