Bangladesh Single Licence Holder and the NOC Mechanism

1. Key takeaways

In Bangladesh practice, a device can only have one licence holder at any given time. That licence holder is the holder of the registration certificate and the DAR, and every importation requires a No Objection Certificate (NOC) issued by that holder. Together these two features form a “licence lock-in”: without the licence holder’s NOC, goods cannot enter Bangladesh; without the licence holder’s cooperation, the registration cannot be transferred away either.

• One device has only one licence holder: an interviewed practitioner stated, “DGDA only allows one license holder per device” (practical estimate).
• Each importation requires an NOC from the licence holder: “the license holder issues a No Objection Certificate (NOC) for each importation” (practical estimate).
• The obligated parties are the manufacturer or the importer, per §4.6 and §5 of the DGDA Medical Device Registration Guidelines (Guidelines provision).
• A source conflict exists: another account states that “each importer must hold its own DAR” — conflict flagged, pending verification (see the dedicated article).
• Transfer requires three documents: the original registration certificate, a no objection letter, and the manufacturer’s transfer authorisation (practical estimate).

2. Legal basis

The table below consolidates the basis for the single licence holder finding and the NOC mechanism. The single-holder rule and the per-importation NOC come from an interviewed practitioner and are classified as a practical estimate. The allocation of obligations to the manufacturer or the importer is anchored in §4.6 and §5 of the Guidelines. The conflicting DAR account is explicitly flagged as pending verification rather than silently resolved, and the transfer document set is presented in the dedicated article.

3. Expert insights

Insight one: the NOC is a Bangladesh-specific “switch on every importation”. Most Southeast Asian markets have no per-shipment NOC mechanism — holding a registration certificate is sufficient to import. The Bangladesh NOC gives the licence holder a veto at every single importation. Where the licence holder and the distributor are the same entity, the bargaining position is completely asymmetric: the party that controls market access also controls the flow of goods, and every commercial dispute is leveraged through the import gate itself. The asymmetry is structural rather than contractual, which is why it cannot be negotiated away in a moment of dispute — it has to be designed out before the relationship begins.

Insight two: licence lock-in plus a three-document transfer equals a high exit cost. The dedicated transfer article details that a transfer requires three documents, one of which — the original registration certificate — is held in the custody of the licence holder. If the licence holder refuses to release it, the manufacturer’s only remaining exit path is litigation — an interviewed practitioner explicitly stated that this is “a common situation; even global giant manufacturers have faced it”. The structural lesson is that exit costs are created at signing, not at exit: whatever rights the manufacturer does not secure in the agreement are the rights it must later buy back through dispute. In practice, the three-document requirement means the licence holder holds two of the three keys to the manufacturer’s market access, and only the agreement — signed while relations are still good — can rebalance that position.

Insight three: the Guidelines themselves do not explicitly state that the licence holder is unique. The provisions of §4.6 and §5 hang the obligations on “the manufacturer or the importer” in parallel, and nowhere is it written that “a device can only have one licence holder”. This is the grey zone between the practical estimate and the Guidelines text, and it is the direct basis for our advice that clients should not place their commercial lifeline in someone else’s hands. Because the single-holder rule rests on practice rather than an express provision, written confirmation from DGDA is the only way to convert an assumption into a documented position.

4. Practical recommendations

• Keep the licence holder and the distributor separate, so the party controlling market access is not the party negotiating commercial terms.
• State a deadline for NOC issuance in the agreement — we require the local partner to commit to issuing the NOC within 72 hours of confirmation.
• State in the agreement the conditions and deadline for the licence holder to return the original registration certificate.
• State in the agreement that the manufacturer has the right to unilaterally replace the distributor.
• Only when all four of these clauses are in place does the manufacturer genuinely hold market control; missing any one of them, the registration certificate can become a bargaining chip in someone else’s hands.
• Evaluate the risk of the licence holder and the distributor being the same entity, record the decision basis, and seek written confirmation from DGDA on the single-holder question where applicable.

5. Verification checklist

• □ The identity of the current licence holder and the DAR number have been confirmed
• □ The agreement sets a deadline for NOC issuance (recommended ≤72 hours)
• □ The agreement sets the conditions and deadline for the licence holder to return the original registration certificate
• □ The agreement preserves the manufacturer’s right to replace the distributor
• □ The risk of the licence holder and the distributor being the same entity has been evaluated and the decision basis recorded
• □ Written confirmation has been sought from DGDA on the conflicting “one licence holder per device” account (where applicable)

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

Regulatory information verified as of October 27, 2026.