Bangladesh Post-Market Surveillance and DGDA Market Visits

1. Key takeaways

Once a Class B, C or D device is on the Bangladesh market, the manufacturer must operate post-market surveillance (PMS) systematically, and this is an explicit obligation in the guideline rather than an expectation inferred from good practice. The counterpart action on the DGDA side is the market visit, used to check product quality, labelling and MRP compliance. Together the two form a two-layer structure: self-monitoring by the company, and verification by the regulator. A device file that satisfies only the first layer is exposed at the second, and the exposure usually appears at the shelf rather than in the dossier.

• PMS is a systematic obligation for Class B, C and D devices, and the guideline uses the word systematically in setting it.
• A PMS system that only responds to complaints does not meet the wording, because the obligation is to monitor performance during use rather than to react to reported failures.
• DGDA conducts market visits that examine product quality, labelling and MRP compliance at the point of sale.
• Labelling and MRP are determined at registration, so a market visit tests decisions taken months or years earlier.
• §4.9 allows sampling under the procedure of the Drugs Act 1940 and, where that is not applicable, allows DGDA to take other measures.
• Those other measures give DGDA a route to request documents such as instructions for use, traceability records and the vigilance log, not only physical samples.

2. Legal basis

The obligation and the verification power sit in different articles of the same guideline, which is why the two should be read together. The table sets out the obligation, the class trigger, the sampling and verification provision, and the safeguard clause.

The structure of the obligation matters as much as its content. Section 5 does not say that a manufacturer must handle complaints; it says that a manufacturer shall adhere to PMS requirements in order to monitor performance systematically while the device is in use in Bangladesh. That is a positive duty to look, expressed with an adverb that rules out a passive posture. Section 4.9 then supplies the regulator with the means of checking whether the duty has been performed, first through sampling under the Drugs Act 1940 procedure and, where that procedure does not fit, through other measures. Section 9 sits behind both as the consequence if the checks reveal a problem.

3. Expert insights

Insight one: PMS is a systematic obligation, and the guideline uses the word systematically. The text of §5 emphasises monitoring the performance of the device systematically during use. This means a company cannot limit itself to reactive complaint handling. What the wording calls for is an active, documented monitoring mechanism: scheduled follow-up with users, structured collection of performance data, and tracking of literature and of vigilance information on comparable products. The distinguishing feature of a compliant system is not the volume of records but the fact that the records exist in the absence of complaints, generated by a schedule rather than by an event.

Insight two: market visits look at labelling and MRP, and both were settled at registration. What a visiting officer can see directly is limited and concrete: whether the label carries the importer name, the expiry date and the batch number, whether the MRP is marked, and whether the selling price exceeds the approved figure. These are not new requirements created at the shelf; they are the visible end of decisions taken during registration. That is the sense in which registration compliance is ultimately tested on the shelf, and it explains why a labelling discrepancy that seemed minor in the dossier becomes a finding in the field.

Insight three: §4.9 allows DGDA to take other measures, and that opening is wider than sampling. The article provides for sampling, but it does not stop there: where the sampling procedure is not applicable, DGDA may take such other verification measures as it considers necessary. In a market visit this means the regulator is not confined to taking a product away for testing. It can request the instructions for use, the traceability record, the vigilance log and the other documents that show whether the system described in the guideline actually exists. The practical consequence is a document-location question: a file that can only be produced by asking the overseas parent company will not be produced within the timeframe of a visit.

Insight four: the two layers are not redundant, because they test different things. Self-monitoring tests whether the company knows what its device is doing in the market. A market visit tests whether what the company says about the device matches what is physically on the shelf. A company can pass the first and fail the second, which happens when the monitoring system is well documented but the label on the box was printed to an older specification. Equally, a company can pass a visit and fail the first, which is the more common situation and the more dangerous one, because the absence of a PMS record is discovered later, during renewal, when it cannot be reconstructed.

Insight five: the safeguard clause gives the visit a consequence. A market visit is not only an inspection exercise. Section 9 provides that where DGDA considers a device may endanger health or safety, it shall take all appropriate temporary measures to withdraw, prohibit or restrict marketing. A labelling or MRP finding on its own is unlikely to reach that threshold, but a file where such a finding sits alongside a missing vigilance record is harder to defend. The lesson is that smaller findings should not be left open, because they are what gives the larger provision its foothold.

4. Practical recommendations

• Build a PMS system for Class B, C and D products that goes beyond complaint handling, with scheduled activity that would still take place in a year without a single complaint.
• Document an annual PMS plan setting out monitoring frequency and methods, so that the systematic character of the obligation is visible on paper.
• Maintain a performance data collection form drawing on key hospitals or channels, which turns routine contact into structured evidence.
• Keep a vigilance log with knowledge-date entries, maintained by the local licence holder rather than held only at the manufacturer.
• Produce an annual PMS summary for submission at renewal, so that the year’s monitoring is available as a single document when it is needed.
• Hold a copy of the regulatory dossier in Bangladesh, including registration materials, label specimens and the MRP approval documents, so that a market visit does not require a request to an overseas office.
• Self-check labelling and MRP compliance at the point of sale on a regular schedule, using the same criteria a visiting officer would apply.

5. Verification checklist

• □ A PMS system is in place for Class B, C and D products, and it is not limited to complaint handling
• □ The annual PMS plan and the annual summary are both documented
• □ The vigilance log is maintained by the local licence holder
• □ A copy of the regulatory dossier is held in Bangladesh
• □ Labelling and MRP compliance are self-checked at the point of sale on a regular schedule
• □ The team is aware that §4.9 permits DGDA to take verification measures beyond sampling
• □ Findings from previous visits are closed and evidenced, rather than left open

Regulatory information verified as at 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