Local Authorised Representative (LAR) Eligibility: Drug Import Licence and Trade Licence

1. Key takeaways

A company that acts as the local authorised representative (LAR) for a medical device in Bangladesh must be a Bangladeshi company registered in the country, and it must hold both a Drug Import Licence (DIL) and a trade licence. An overseas manufacturer is required to appoint such a company as its authorised agent or importer, and that company submits the registration application and carries the legal responsibility attached to the product. The eligibility threshold is therefore not a formality. It removes the option of asking a friendly company to sign on the manufacturer’s behalf, because the signing entity must itself be licensed to import drugs before it can hold anything on the manufacturer’s account.

• The LAR must be a locally registered Bangladeshi company, not a branch, a representative office or an individual consultant.
• Two licences are required together: the DIL and the trade licence. One without the other does not satisfy the threshold.
• The manufacturer cannot file in its own name; the application is submitted by the appointed local company, which is also the party that answers for the product afterwards.
• The DIL is a drug import licence. Because devices are regulated as drugs in Bangladesh, a device importer uses the drug instrument.
• The obligation is drafted on both ends of the chain, manufacturer or importer, but only the local end is reachable in practice.
• Licence status should be verified before commercial terms are discussed, since a partner without a valid DIL cannot carry a registration through to grant.

2. Legal basis

The requirement is built in two layers, and both matter when a partner is being assessed. The first layer is the parent statute, whose long title defines the activities that fall inside the regulatory perimeter. The second layer is the registration guideline issued by the Directorate General of Drug Administration (DGDA), which attaches the application and post-market obligations to a named party. The table below sets out each element against its source.

Two points in the drafting carry most of the weight. The statute is dated 18 September 2023, which means the framework described here is recent and should be read as the current baseline rather than as an amendment to an older instrument. The guideline then does not create a separate device licensing system for foreign applicants; it routes the obligation through the manufacturer or the importer, and the importer is the only one of the two that exists as a legal person inside Bangladesh. That is why a document check on the local company is a legal question and not only a commercial one.

3. Expert insights

Insight one: the title of the Act is itself a list of regulated steps. The full name of the Drug and Cosmetics Act, 2023 places manufacture, import, export, buying and selling, storage, display, distribution and quality control side by side. Because a device is defined as a drug, all eight activities apply to devices. This single drafting choice explains a great deal of what follows in practice: it is why a warehouse needs its own licence, why a distribution entity needs its own licence, and why a display space falls inside the perimeter. Nothing in the Act carves devices out of those eight steps, and nothing in the guideline restores an exemption that the parent statute does not give.

Insight two: the guideline hangs the duty on both ends, and the LAR is the end where the duty lands. Sections 4.6 and 5 both name the manufacturer or importer. An overseas manufacturer has no enforceable presence in Bangladesh, so the party DGDA can actually reach is the local importer. That asymmetry is the fundamental reason the LAR eligibility threshold exists. It is not a documentary preference or a filing convention; it is the mechanism through which responsibility becomes enforceable. Reading the two sections together also explains why the appointment cannot be informal. A letter of authorisation that names a company without a DIL produces an application that no one is able to defend at the point of inspection.

Insight three: the DIL is a drug import licence, not a device import licence. Because devices are treated as drugs, device import runs on the drug instrument. For a local company that works only in devices, this is a real threshold: it must first obtain a DIL within the drug system before it can hold a device registration at all. The consequence for a manufacturer is that the shortlist of credible partners is narrower than the number of companies that describe themselves as medical device distributors. A partner that has never held a DIL has no route to the licence simply by being interested in the product.

Insight four: eligibility is a point-in-time test, and the licence has an expiry date. Holding a DIL is not a permanent attribute of a company. It is a licence with a validity period, and a partner whose licence lapses during the registration cycle leaves the application without a sponsor. This is why the eligibility question is asked twice: once when the partner is selected, and again before each submission that depends on the partner’s standing. The same logic applies to the trade licence, which is the instrument that establishes the company may trade at all.

4. Practical recommendations

• Verify three documents before a partner enters the shortlist: the certificate of incorporation, the DIL and the trade licence. All three must be in the name of the same legal entity.
• Check the DIL original rather than a copy, confirm the expiry date, and diarise a review date well before that expiry so that a renewal is not discovered during a submission.
• Search the company’s record for violations in the current year, since a clean licence and an adverse record can coexist and both are relevant to how the partner will behave under inspection.
• Do not accept a partner whose paperwork is described as being in process. If the DIL is not granted, applications already filed become void, and the cost is measured in a quarterly committee cycle rather than in days.
• Write three obligations into the appointment agreement: submission, vigilance and market inspection support, so that the responsibilities the guideline places on the importer are contracted back to the party that will perform them.
• Confirm in writing which entity will appear on the registration certificate, because the name on the certificate determines who can release the product later.

5. Verification checklist

• □ The candidate LAR is a Bangladeshi company registered in the country
• □ The DIL original has been inspected and is within its validity period
• □ The trade licence has been inspected
• □ The company’s violation record has been searched
• □ The agreement assigns the LAR the three duties of submission, vigilance and market inspection
• □ No partner whose licences are described as in process has been accepted

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