Custom-Made Devices in Bangladesh: Where the Statement Requirement Applies

1. Key takeaways

Bangladesh permits custom-made devices to be put into service, on condition that a statement accompanies them. §6.1 of the DGDA Medical Device Registration Guideline provides that a custom-made device may be put into service when placed on the market, provided it is accompanied by a statement, and that the statement must be available to the particular patient or user identified by name, an acronym or a numerical code.

• The condition is documentary, not a registration: the statement stands in place of a registration certificate for this category.
• The statement must be available to the particular patient or user, which makes delivery part of the obligation.
• Identification may be by name, acronym or numerical code, so anonymised identification is permitted.
• Put into service is the operative phrase, and it is narrower than placing on the market for general sale.
• Devices fall within the Drug and Cosmetics Act, 2023 (Act No. 29 of 2023, in force 18 September 2023) through its definition provisions.
• A safeguard in §9 allows DGDA to withdraw, prohibit or restrict marketing where a device may endanger health or safety.

2. Legal basis

The provision sits in the same part of the guideline as the exhibition exemption, and it works in a similar way: it creates a route for a category that cannot sensibly be registered in advance, and it attaches a documentary condition to that route. The table below sets out the elements with the guideline wording intact, because the identification clause is where most drafting errors occur.

Two features of the drafting carry practical weight. The first is that the statement is not described as a document to be filed with DGDA; it is described as being available to a particular patient or user. That locates the obligation at the point of delivery rather than at the point of application. The second is that the identification clause offers three alternative forms, one of which is a numerical code. The alternatives are written as options, not as a hierarchy, so a manufacturer may select the form that fits its own data protection policy.

3. Expert insights

Insight one: §6.1 places custom-made devices outside the registration system but catches the risk with a statement. Custom-made devices are difficult to put through routine registration precisely because they are individualised: there is no stable configuration to assess in advance. Bangladesh does not exempt them entirely. It substitutes a statement for the registration certificate, and the statement fixes responsibility and traceability in a document that travels with the device. That is a lighter regime than registration, but it is not an absence of regulation, and the manufacturer still has to be able to produce the statement on request.

Insight two: the provision is generous about how the user is identified. Name, acronym or numerical code, any one of the three. That drafting choice permits anonymised handling, using a numerical code, which satisfies the traceability requirement while protecting privacy. A hospital that does not want patient names circulating in a manufacturer’s file can use a code, and the provision accommodates that. Companies designing a statement template can therefore choose the identification method that fits their own data protection policy, rather than defaulting to names because the guideline appears to demand them.

Insight three: put into service is not the same as free sale. The provision says put into service, and the object is a particular patient or user. It is not a general authorisation to sell to the market. If a custom-made device is produced in batches and sold generally, §6.1 no longer applies to it, and the product has to return to the routine registration path. The distinction matters commercially as well as legally: a product that starts as a bespoke solution and gradually acquires a standard catalogue has crossed a line without any single decision marking the crossing.

Insight four: the safeguard in §9 means the lighter route is not a lighter exposure. DGDA may withdraw, prohibit or restrict marketing where it determines that a device may endanger health or safety. That power applies regardless of which route the device entered the market under, so a custom-made device that turns out to be unsafe is not protected by the fact that it never held a registration. For the manufacturer, the practical meaning is that clinical justification for the customisation should be documented at the time of supply, since it is the first thing that will be examined if the device is later questioned.

4. Practical recommendations

For custom-made device clients, GRZAN prepares a standard statement template with four elements: a description of the device and the basis for customisation, the specific user identified by name, acronym or numerical code, the manufacturer and the clinical fitting party, and the precautions for use. We require clients to deliver the statement together with the device and to retain a copy on file. The reason is that the obligation in §6.1 is that the statement must be available to the named patient, and if it is not delivered at the same time as the device, the obligation has not been met.

• Confirm at the outset that the device is genuinely custom-made and not a standard product configured at the point of sale.
• Use a statement template containing the four elements, and review it whenever the device design changes.
• Select the identification method deliberately, whether name, acronym or numerical code, and record the choice in the quality system.
• Deliver the statement with the device and archive a copy, since availability to the patient is the condition the provision imposes.
• Keep the custom-made device out of general sales channels, and monitor for catalogue drift towards a standard product.
• If production becomes batch or serial, plan the move back to the routine registration route before the first batch ships.

5. Verification checklist

• □ The device is confirmed as custom-made and not a batch or general product
• □ The statement template contains the four elements: device description, user identification, manufacturer details and precautions
• □ The user identification method has been selected, whether name, acronym or numerical code
• □ The statement is delivered with the device and a copy is retained on file
• □ The device is confirmed as not entering general sales channels
• □ A return to the routine registration route has been planned in case production becomes batch-based

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