Samples and Testing: Quantities, Laboratories and Timelines

1. Key takeaways

The sample requirement commonly applied in Bangladesh is 2 samples or a colour catalogue; for Class A, 1 piece may be requested where the product is uncommon. Before the samples can be imported, a DGDA sample NOC must be obtained, with the purpose stated as Testing and Registration Purposes. Where testing is involved it may be carried out by the National Control Laboratory (NCL); if the NCL lacks the capability, the DGDA technical committee may accept a method validation report or an ISO/IEC 17025 accredited report from the manufacturer’s own laboratory. Sample quantities and testing timelines vary between sources and are recorded as pending verification.

The item looks administrative and is not. Samples cannot be shipped as ordinary goods, cannot be released without a NOC, and cannot be substituted after arrival if the quantity turns out to be wrong. The sequence is short but strictly ordered, and each step depends on the one before it.

• Default quantity: 2 samples or a colour catalogue.
• Class A exception: 1 piece, for uncommon products only.
• Pre-shipment step: DGDA sample NOC for Testing and Registration Purposes.
• Testing route: NCL where capable; method validation or ISO/IEC 17025 report where not.
• Open variables: quantity and testing time differ by source, pending verification.

2. Legal basis

The legal anchor is §4.9 of the DGDA medical device registration guideline, which directs that sampling be carried out according to the procedure of the Drug Act 1940 as far as possible, and provides that where the nature of the device makes that procedure inapplicable, DGDA may take other verification measures. The remaining entries in the table come from submission practice and from single-source reports, and are marked accordingly so that their evidentiary weight is clear.

The structure of §4.9 explains why alternative evidence is arguable at all. The provision states a preferred method and then expressly contemplates that the method may not fit, leaving DGDA a discretion to use another. It does not name the alternatives, and it does not describe how they are to be assessed, which is why the alternatives are documented in practice rather than in the text.

3. Expert insights

Insight 1: §4.9 is a method-open clause. The provision says, in substance, that where sampling can follow the drug law procedure it should, and where it cannot, DGDA may take other measures. That opening is the institutional space in which method validation reports and ISO 17025 reports become acceptable. The provision does not expressly recognise alternative evidence, and it does not prohibit it. Our documents describe the alternative route as arguable on that basis, and mark its status as pending verification, because a discretion exercised in practice is not the same as a right conferred by text. The practical value is still real: an applicant who arrives with a validation report and an accredited laboratory report gives the committee a documented option rather than a request.

Insight 2: the sample NOC is an easily overlooked precondition. Companies often assume that a sample is not a commercial good and can simply be couriered. Samples imported for registration purposes in fact require a DGDA sample NOC obtained in advance, which is what gives the consignment a basis at customs. Without it, the samples can be held at customs, or treated as goods and required to hold a registration certificate, which is a circular requirement: the samples are needed to complete the registration that the samples are said to require. The delay is not measured in days, because the consignment has to be re-characterised rather than re-documented.

Insight 3: three positions on sample quantity coexist. The main position is 2 pieces. A second position is 1 piece for uncommon Class A products. A third, from a single source, is 3 pieces sent to BSTI. The differences are not necessarily contradictions: they may reflect different product families, different testing routes or different points in time. Our approach is to prepare on the basis of 2 pieces and to confirm the current requirement with the local partner before shipment, because the cost of one extra unit is trivial and the cost of a short shipment is a second consignment.

Insight 4: the timeline question has no stable answer. Testing duration depends on the laboratory’s queue and on whether the device needs testing at all. Since the sources differ, the only safe planning assumption is that testing is on the critical path until the local partner confirms otherwise.

4. Practical recommendations

GRZAN asks clients to reserve samples at an early stage and to run the sample workstream alongside the attestation chain. The samples themselves do not require attestation, but the import NOC must be applied for in advance. Our sequence is to confirm the quantity and specification first, then apply for the sample NOC, then arrange shipment, and never to ship before the NOC is in hand. For products such as Class D devices that may require in-country testing, we prepare, in parallel, a method validation report and copies of ISO/IEC 17025 reports, so that the file already contains the alternative evidence if the NCL reports that it lacks the capability.

• Confirm quantity in writing. Default to 2 pieces, adjust if the local partner reports otherwise.
• Apply for the NOC before booking freight. The consignment has no customs basis without it.
• Describe the purpose exactly. Testing and Registration Purposes is the formulation that is recognised.
• Prepare the fallback evidence early. Method validation and accredited laboratory reports for products likely to need testing.
• Keep the colour catalogue ready. It can serve as a substitute or a supplement where physical samples are impractical.

5. Verification checklist

• □ Sample quantity confirmed with the local partner for the current cycle, with 2 pieces as the default
• □ 1 piece prepared for uncommon Class A products where applicable
• □ Sample NOC for Testing and Registration Purposes obtained before shipment
• □ Colour catalogue prepared as a substitute or supplement for the samples
• □ Method validation report or ISO/IEC 17025 report prepared where in-country testing is possible
• □ Differences in sample quantity and testing time recorded as pending verification items

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