Bangladesh Medical Device Registration: Roles and Responsibilities

1. Key takeaways

Medical device registration in Bangladesh involves four roles: the overseas manufacturer, which holds the technical and quality evidence; the local authorised representative (LAR), which must be a company registered in Bangladesh and must hold a drug import licence (DIL) and a trade licence; the licence holder, in whose name the registration certificate and the DAR stand; and the distributor, which carries out the actual commercial sale. In practice a foreign manufacturer must appoint a Bangladesh-registered company as its authorised agent or importer to submit the application and to bear the associated legal responsibility. The four roles can be carried by two entities, but the functions cannot be allowed to blur. The structure chosen at the outset therefore shapes the commercial position for the whole life of the registration.

• Four distinct functions, even where fewer than four parties exist.
• The local party must hold a DIL and a trade licence before it can file anything.
• The guidelines attach post-market duties to the manufacturer or the importer, without choosing between them.
• Registration and distribution combined in one party transfers negotiating leverage.
• One device has one licence holder at a time, a point carrying a documented source conflict.

2. Legal basis

The guidelines do not draw a single-responsibility model. They place obligations on the manufacturer and the importer in parallel, which is why the contractual allocation matters more here than in markets where the local party is the sole duty holder.

3. Expert insights

Insight one: the guidelines hang the obligation on the manufacturer or the importer, both of them. Section 5 places the duty on the manufacturer or the importer without ranking the two, and §4.6 requires manufacturers and importers to apply, again without selecting one. The consequence is that the DGDA does not presuppose a single responsible party. It attaches obligations to the overseas manufacturer and to the local importer side by side. When something goes wrong, both ends are exposed, and a manufacturer that assumes the local party absorbs all enforcement risk is reading the provision the wrong way round. A joint obligation also means a joint defence is rarely available, since each party is judged on what it did rather than on what the other promised.

Insight two: combining licence holder and distributor is the largest commercial risk source in Bangladesh. The licence holder is also the issuer of the no objection certificate that every import consignment requires, and that certificate determines whether the distributor can obtain stock at all. Where licensing and distribution sit in the same entity, the channel negotiation power has been handed to the counterparty. The point is developed further in the thirty-second article of this series. It is a structural issue rather than a matter of choosing a reliable partner, because a reliable partner today may be a different negotiating counterparty once the certificate carries its name. The imbalance becomes visible only when volumes grow or when a second distributor is proposed.

Insight three: the local representative is not a nominal appointment; it has qualification thresholds. In practice the LAR must hold a drug import licence (DIL) and a trade licence. Without both, the party does not even hold standing to submit. That single requirement removes the option of asking an acquaintance’s company to sign a letter and lending the application a local address. A party without the licences cannot perform the function, whatever the agreement says. The licences attach to the entity rather than to individuals, so a change of key personnel does not disturb standing while a change of corporate structure does.

4. Practical recommendations

• Separate licensing from distribution. Place the registration certificate and the DAR in an entity that does not carry out commercial distribution, which may be a locally licensed partner working alongside the manufacturer, and leave selling to the distributor.
• Under that structure the manufacturer retains three things: control of the original certificate, the rhythm at which import certificates are issued, and the freedom to replace a distributor. Each of the three is worth writing into the agreement as an obligation rather than leaving it as an expectation.
• Set out in the agreement the conditions on which the licence holder issues the import certificate and the response time it commits to, since the certificate governs stock availability rather than merely paperwork.
• Record in writing whether the licence holder and the distributor are the same entity, and if they are, record the risks that combination creates and the mitigations agreed.
• Agree in writing the conditions and the deadline for the return of the original registration certificate, so that a change of partner does not turn into a dispute about documents.

5. Verification checklist

• □ The four roles of overseas manufacturer, LAR, licence holder and distributor have been identified
• □ The LAR is confirmed as a Bangladesh-registered company holding a DIL and a trade licence
• □ The conditions and response times for issuance of the import certificate are set out in the agreement
• □ Licence holder and distributor agreed as separate entities, or the combined structure and its risks recorded in writing
• □ The conditions and deadline for return of the original registration certificate are agreed in writing

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