Bangladesh Medical Device Classification: Class A, B, C and D

1. Key takeaways

Bangladesh divides medical devices into four classes: Class A (low risk), Class B (low to moderate risk), Class C (moderate to high risk) and Class D (high risk). The scheme is closely aligned with the ASEAN Medical Device Directive (ASEAN MDD). At the level of law, the anchor is the definition clause of the Drug and Cosmetics Act, 2023 (Act No. 29 of 2023). At the level of practice, the anchor is §4.4 of the DGDA Medical Device Registration Guidelines (Device Classification v 1.0). That provision does no more than state that devices are divided into four product classes. It attaches no product-by-product list. The absence of a list is not an oversight in the drafting. It is the operating condition under which every classification decision in Bangladesh is made. Classification is therefore not a formality that precedes the project; it is the assumption on which the whole project is priced and scheduled.

• Four classes, A to D, in ascending order of risk, modelled on the ASEAN framework.
• No official product list accompanies §4.4, so the first determination belongs to the applicant.
• The authority reviews the determination at the recipe approval stage, not at intake.
• Product codes on a certificate follow the free sale certificate that was filed.
• Combination products are handled at the highest class present in the combination.

2. Legal basis

The distinction between what the guidelines state and what the market treats as settled is worth keeping visible. Two rows in the table below rest on registration practice rather than on the text of the guidelines, and they carry the practical estimate label for that reason.

3. Expert insights

Insight one: without an official list, the classification duty lands on the applicant. Section 4.4 establishes the principle of four classes and stops there. It does not attach a classification rule annex of the kind found in the European MDR, where each rule describes a product type and a resulting class. The structural consequence is that the applicant must reach a determination first, and the DGDA reviews that determination later, during the recipe approval stage. This changes the cost of an error. A determination set too low does not merely generate a request for further documents, because the review point is the first formal step and that step convenes quarterly, as described in the twelfth article of this series. A wrong class therefore costs a full cycle rather than a correction. The reasonable response is to document the determination properly at the outset, so that the review is a confirmation of a reasoned position rather than the first occasion on which the question is examined.

Insight two: product codes travel with the CFS. The range of product codes printed on a registration certificate is, in practice, determined by the list contained in the free sale certificate (CFS) that was submitted. The implication is direct: a product that is not written on the CFS will not appear on the certificate. Adding a product later means obtaining a further CFS and running a further round of formalities. This is why the CFS in Bangladesh is not simply a certificate of standing but the boundary document that defines the scope of the registration itself. It also explains why the CFS product list deserves the same care as the technical file, since an omission there cannot be cured by argument at a later stage.

Insight three: combination devices are classified at the highest risk level in the combination. A combination product, such as a drug-eluting device or a device sold as a set with accessories, is handled at the highest class among its components. The point decides whether notified body certification is required and whether a reference country CFS is required, so it is the dividing line for project cost rather than a technical footnote. A set packaged together is assessed as a set, not component by component, even where the accessory alone would sit several classes lower. Pricing a project from the accessory will therefore understate both certification cost and evidence requirements, and the error is usually discovered only once the notification requirement is raised.

4. Practical recommendations

• Sequence the work as classify, then quote, then submit. Submitting before a class is settled tends to produce a file that has to be rebuilt rather than amended.
• Issue a written classification opinion at project start covering four things: the class the product falls into, the reasoning behind it, how any combination element is handled, and the expected CFS coverage.
• Keep that opinion as the working paper for later dialogue with the DGDA, since the review at recipe approval will test exactly those four points.
• Build the CFS product list once and build it complete. Extending coverage later through piecemeal additions triggers separate change formalities and their own time cost.
• Confirm class-dependent requirements before quoting, in particular whether notified body certification applies to Class B, C and D, and whether a reference country CFS applies to Class C and D.

5. Verification checklist

• □ A written classification opinion has been issued and the reasoning retained on file
• □ Combination devices have been confirmed as classified at the highest class in the combination
• □ The product list on the CFS has been confirmed to cover the intended registration scope
• □ Notified body certification requirements have been confirmed by class, applying to Class B, C and D
• □ Reference country CFS requirements have been confirmed by class, applying to Class C and D

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