Bangladesh IVD and Diagnostic Reagent Regulation: Class and Filing

1. Key takeaways

Bangladesh has no standalone IVD regulation. In vitro diagnostic reagents are written directly into the device definition of the Drug and Cosmetics Act, 2023 (Act No. 29 of 2023), where they appear as in vitro diagnostic reagents. The consequence is systemic: IVDs and medical devices share the same definition, the same four-class scheme and the same two-step registration process. A Class C or Class D IVD must submit a reference country CFS in the same way as a device at that class, and its certificate is likewise valid for five years. There is no separate IVD annex, no separate IVD classification rules, and no separate IVD submission route to look for.

• One definition covers devices and IVDs alike, including in vitro, in vivo and in silico reagents.
• The four classes apply to IVDs without modification.
• Reference country evidence is required at Class C and Class D.
• Physical packaging components, not just documents, form part of the submission.
• Recall history for the past two years is a standing requirement for the file.

2. Legal basis

The legal position is short; the practical document list is long. The table separates the two, so that the guideline provisions relied on can be distinguished from registration practice.

3. Expert insights

Insight one: merging IVDs into the device framework removes one problem and creates another. In China and in the European Union, IVDs have their own classification system, and the IVDR classification for IVDs rests on grounds quite different from those used in the MDR. Bangladesh has none of that layer, so IVDs simply take the four device classes. The practical benefit is a low cost of classification dialogue. The price is the absence of IVD-specific performance evaluation rules. When a question turns on indicators such as sensitivity and specificity, the analysis has to return to the ISO standards and essential requirements described in §7.1, because no dedicated IVD performance annex exists to consult. Reviewers and manufacturers therefore argue from the same generic standards, which is workable but less instructive than a purpose-built IVD rule set.

Insight two: packaging materials are a hard requirement, and they must be empty. The practical list calls for an empty box, the label and the instructions for use (IFU). The label must show the brand and the manufacturer name, the country of origin, the manufacturing date, the expiry date and the batch number. This is not a formal check. The DGDA inspects the physical packaging in order to judge whether the labelling meets §7.2, which means a PDF mock-up does not discharge the requirement. Sending the actual printed components is part of the file, not an optional courtesy. A mock-up proves intent; a specimen proves what will actually reach the shelf.

Insight three: recall history is the credibility document that IVDs share with devices. Recall history for the past two years must be signed by the manufacturer on company letterhead. Its function is to tell the DGDA, before the file is accepted, whether the product has had a safety problem. A recall history does not automatically lead to refusal, but concealment damages trust for the remainder of the relationship, including at the vigilance stage that follows registration. A manufacturer with no recalls should say so in writing and sign the statement, rather than leaving the section blank.

4. Practical recommendations

• Run packaging materials and technical documentation as two parallel workstreams. The technical documentation is compiled to ISO standards, while the packaging is produced separately to the DGDA labelling requirements with physical specimens retained.
• Ask the client to ship the empty boxes to Bangladesh before submission rather than sending PDFs only, because the final stage requires original empty boxes and original labels, as treated in the thirteenth article of this series.
• Obtain the recall history for the past two years in advance, and where there have been no recalls, issue a statement of no recalls signed by the manufacturer instead of an empty page.
• Prepare the reference country CFS in original form with embassy attestation for Class C and Class D, and confirm which country is being used as the reference before the attestation chain begins.
• Include the list of countries where the product is sold and the colour catalogue as standing items, since they are routinely forgotten when a file is assembled from a European dossier.

5. Verification checklist

• □ IVD confirmed as classified under the four device classes, with no search for IVD-specific classification rules
• □ EC certificate prepared for Class B, C and D, and EC design examination certificate prepared for Class D
• □ Class C and D: original reference country CFS prepared and embassy attested
• □ Empty box, label and IFU specimens prepared, with the label showing brand, manufacturer, country of origin, manufacturing date, expiry date and batch number
• □ Recall history for the past two years issued, with a written statement where no recalls exist

Regulatory information verified as of 27 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including Bangladesh. Our team prepares dossiers to DGDA expectations, manages submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com