Penalties for Unlicensed Medical Devices Under the Bangladesh Act of 2023

1. Key takeaways

In Bangladesh, dealing in medical devices without a licence falls within the penalty framework of the drug law, because a device is defined as a drug. Under the Drugs and Cosmetics Act, 2023 (Act No. 29 of 2023, in force on 18 September 2023), manufacture without a licence carries imprisonment of up to 10 years or a fine of up to 1,000,000 taka, or both. Adulteration carries imprisonment up to life, or up to 14 years, together with a fine of up to 1,000,000 taka. The Act also expands the categories of punishable conduct from 6 categories under the 1982 ordinance to 30 categories. For a device company, the decisive point is not the size of the numbers but the fact that the statute behind them is a criminal statute with imprisonment attached.

• A medical device is legally a drug in Bangladesh, so device offences are prosecuted under the drug law rather than under a separate device statute.
• Manufacture without a licence carries up to 10 years imprisonment or a fine of up to 1,000,000 taka, or both.
• Adulteration carries up to life imprisonment or up to 14 years, with a fine of up to 1,000,000 taka.
• Adulterated cosmetics carry up to 5 years and a fine of up to 500,000 taka, and sale without a prescription carries a fine of 20,000 taka.
• Punishable conduct has expanded from 6 categories to 30 categories, which indicates the direction of enforcement more clearly than the penalty figures do.
• The figures quoted here come from media reporting of the legislation, not from our own reading of the gazette, and labelled as such.

2. Legal basis

The table records the provisions and, just as importantly, the source of each figure. Rows drawn from media reporting are marked as such, because a penalty figure that cannot be traced to the gazette should not be presented in a client document as though it had been verified.

The definition clause is the hinge of the whole framework. Because a device is defined as a drug, the licensing provisions, the adulteration provisions and the price provisions all apply to devices without any device-specific penalty of their own. That is why a company cannot reason by analogy with markets that have a separate device statute: there is no separate statute to fall back on, and the only route to lawful trading runs through the licensing chain the drug law establishes.

3. Expert insights

Insight one: what puts pressure on device companies is not the penalty figure but the premise that a device is a drug. Companies often assume the worst outcome of a device violation is a fine or withdrawal of a certificate. In Bangladesh the applicable law is the drug law, and it carries imprisonment. That is the starting point for understanding how seriously compliance is treated here: a delay in registration is a commercial problem, while trading before registration is a personal legal exposure for the individuals who sign the documents.

Insight two: this series takes a conservative approach to the penalty figures. The ranges above come from legislative reporting in the mainstream Bangladeshi media; they are not provisions we have checked directly against the gazette. Our external documents therefore always carry the annotation that these are penalty ranges as reported in the media and that the specific provisions are subject to the gazette text. For serious matters we require a separate opinion from Bangladeshi counsel. This is a deliberate boundary: we do not make legal assertions we cannot verify, even where they would make a document more persuasive.

Insight three: thirty categories against six tells us more about direction than the penalty numbers do. A change in the number of punishable categories is a structural signal, because it widens the surface on which an enforcement action can be brought. For a device company, the compliance checklist in Bangladesh therefore has to extend beyond product registration to storage, display, distribution, pricing and prescription. Each of those is conduct that the statute expressly covers, and each of them is a place where a company that has registered its product correctly can still commit an offence through a distributor or a warehouse.

Insight four: the enforcement structure is itself part of the signal. Media reporting indicates that under the new Act DGDA will establish a Department of Drug Prosecution. We treat that item as pending verification, but it belongs in the analysis because a dedicated prosecution function changes the practical consequence of a finding: it implies that cases are intended to be pursued as cases rather than settled administratively, which changes how a finding should be planned for.

Insight five: the price provision is a compliance item in its own right. Selling above the approved maximum retail price is a distinct offence, and the figure we can cite for it comes from the 1982 ordinance, which is the previous law; the current text has to be checked against the gazette. The reason this matters operationally is that pricing is often handled by a distributor without reference to the registration file, so the offence is committed in Bangladesh even where the decision was taken by a third party.

4. Practical recommendations

The compliance advice we give clients is obtain the certificate first, then sell, expressed as a step-by-step list rather than as a principle: product registration, a valid DIL held by the licence holder, intent approval, customs clearance, MRP approval, labelling, and release for sale. Each step produces a document the next step depends on, so the sequence is a chain rather than a preference.

• Complete all seven steps before any commercial sale, and record the date on which each step was completed.
• Do not sell goods under the description of exhibition items or samples; the exhibition exemption discussed in article 39 and the sample NOC discussed in article 29 both carry explicit limits on their use.
• Do not skip MRP approval, because price violations and unlicensed trading are two categories of offence under the same statute in Bangladesh.
• Confirm that the licence holder’s DIL is valid for the period of the intended sale, and re-check it before each shipment.
• Extend the compliance checklist to storage, display and distribution, since the Act covers those stages as separate conduct.
• Label penalty figures as media-reported in every client document, and obtain local counsel advice for any matter with criminal exposure.

5. Verification checklist

• □ It is understood that a device is a drug, which is the premise for the application of the penalties
• □ All seven pre-sale steps have been completed and dated
• □ No goods have been sold under the description of exhibition items or samples
• □ The MRP has been approved and the selling price does not exceed the approved figure
• □ Penalty figures are labelled as media-reported, and local counsel advice has been obtained for serious matters
• □ Storage, display and distribution are licensed and documented
• □ The Department of Drug Prosecution item is recorded as pending verification

Regulatory information verified as at 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