Establishment Licence: Local Manufacturing Plants, Warehouses and Distribution Entities

1. Key takeaways

The establishment licensing requirement in Bangladesh comes from the parent statute itself. The legislative purpose of the Drug and Cosmetics Act, 2023 (Act No. 29 of 2023) covers manufacture, buying and selling, storage, display and distribution, so local manufacturing plants, warehouses and distribution entities each need the corresponding establishment licence. The only explicit exemption is the Class A manufacturer, which does not need to obtain a manufacturing licence from DGDA under §4.5 of the registration guideline.

• Establishment licensing is not a device-specific invention; it follows from the activities named in the statute.
• A manufacturing plant, a warehouse and a distribution entity are three different premises with three different licence positions.
• The Class A exemption in §4.5 is limited to the manufacturing licence and does not extend to any other licence.
• Class A manufacturers still carry a notification duty and must submit a declaration of conformity.
• Class B, C and D manufacturers need quality management system certification from a notified body under §4.6.
• Storage and display appear in the statute, which is why warehouses and display spaces fall inside the licensing perimeter.

2. Legal basis

Two provisions do the work here, and they sit in different instruments. The statute defines the perimeter by naming the activities it regulates; the guideline then narrows one specific requirement for the lowest risk class. The table below sets out each element and its source, keeping the guideline wording in place so that the scope of the exemption can be read exactly as drafted.

The structure of the two provisions explains why confusion is common. Section 4.5 addresses one class and one licence, and it says so in a single sentence. The statute, by contrast, addresses every activity in a list and says nothing about class at all. A reader who starts from §4.5 and stops there will conclude that Class A is lightly regulated across the board. A reader who starts from the statute will conclude that every premises where a regulated activity happens needs a licence, and will then ask which class exemption applies to which of those premises. The second reading is the one that survives an inspection.

3. Expert insights

Insight one: the §4.5 exemption is precise, not general. What the provision removes is the manufacturing licence for Class A, and nothing else. It does not remove the warehouse licence, it does not remove the distribution licence, and it does not remove the Class A notification duty, under which a declaration of conformity must still be submitted. Reading §4.5 as meaning that Class A needs no licence of any kind is the most common misreading of the guideline, and it usually surfaces at the worst moment: when a market inspection asks for the establishment paperwork of a warehouse storing Class A product.

Insight two: storage and display being named in the statute is the direct basis for warehouse licensing. In many markets a warehouse does not need a device-specific permit. In Bangladesh the statute expressly covers storage and display, so a warehouse and a display space fall inside the licensing perimeter as a matter of course rather than by administrative interpretation. This has an immediate consequence for importers choosing third-party logistics: whether the provider’s warehouse holds a licence is a compliance question, not a service-quality question. The goods sit in a licensed activity, and the party answerable for that activity is the licensed importer.

Insight three: the distribution step can be separated from the licensing step, and that is where structural design begins. The statute lists distribution as its own activity, which means the distribution licence is its own certificate. A registration holder does not have to hold a distribution licence, and a distributor does not have to hold the registration certificate. The two functions are legally separable, and that separability is the legal foundation for appointing an independent holder and a separate channel partner. Without the statute naming distribution as a distinct step, the separation would be a commercial preference; with it, the separation is a lawful structure.

Insight four: a site list is a regulatory document, not an internal inventory. Because each premises maps to a licence class, the number of sites determines the number of licences and the number of inspection points. A manufacturer that adds a second warehouse without adding the corresponding licence has created an unlicensed activity rather than extra capacity. The same applies to a display area inside a distributor’s showroom, which is easy to overlook precisely because it looks like a sales facility rather than a regulated premises.

4. Practical recommendations

When a client establishes a local entity in Bangladesh, GRZAN starts with a premises list: whether there is a manufacturing plant, how many warehouses exist, whether there is a display or demonstration space, and whether distribution is handled in-house. Each site maps to one licence class, and a missing licence at any one of them becomes visible during a DGDA market inspection. We place particular emphasis on checking the warehouse credentials of third-party logistics providers, because goods held in an unlicensed warehouse create a liability for the licensed importer, not for the warehouse operator.

• Build the premises list before the entity is incorporated, so that licence applications run in parallel with company registration rather than after it.
• Map each site to its licence class and record the mapping in the quality system, so that a new site triggers a licence review automatically.
• For a Class A plant, document the §4.5 exemption and the declaration of conformity separately, since the two are often confused in internal files.
• For Class B, C and D plants, confirm that the QMS certification is issued by a notified body and that its scope covers the device families concerned.
• Obtain the warehouse licence of every third-party logistics provider and keep a copy in the supplier file, with an expiry date that is monitored.
• Keep the distribution licence and the registration in separate names where the structure allows, so that a change of channel does not disturb the registration.

5. Verification checklist

• □ All premises are listed: manufacturing plant, warehouses, display space and distribution points
• □ Each premises has been mapped to its establishment licence requirement
• □ The Class A plant is confirmed as covered by the §4.5 exemption, with the notification duty still performed
• □ Class B, C and D plants hold QMS certification from a notified body
• □ The credentials of third-party logistics warehouses have been verified
• □ The distribution licence and the registration are confirmed as separable arrangements

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