Two-Year Recall History Declaration: Required for Registration and Renewal

1. Key takeaways

Bangladesh requires the submission of recall history covering the past 2 years, and the declaration must be signed by the manufacturer on company letterhead. The same document is required again at renewal. A recall history does not by itself lead to refusal, but concealment directly damages the trust the rest of the file depends on. Where there has been no recall, the right answer is a written declaration stating that there has been none, not a blank field.

The item is small and is routinely under-prepared. It is one page, it costs almost nothing to produce properly, and it is one of the few documents in the dossier that a reviewer can check against public regulatory databases in a few minutes. That combination, low cost and high verifiability, is why it is worth treating as a substantive item rather than an administrative formality.

• Window: the past 2 years, counted back from the submission date.
• Form: signed on the manufacturer’s letterhead, not on agent letterhead.
• Renewal: the declaration is required again, not carried forward from the initial registration.
• Nil returns: a written statement that no recall occurred, rather than an empty section.
• Scope: all markets where the product is sold, not only the country of manufacture.

2. Legal basis

The recall declaration is a submission requirement described in the practical list as details regarding recall history of the past 2 years, duly signed on the letterhead pad of the manufacturer. It sits within a wider post-market framework in the guideline: §5 requires systematic post-market surveillance for Class B, C and D devices and the analysis and reporting of serious adverse events to the DGDA-designated body, and §9 gives DGDA the power to withdraw, prohibit or restrict marketing where a device may endanger health or safety. The declaration is the historical end of that framework.

Nothing in these provisions turns a recall into a bar to registration. What they do is establish that the regulator takes the safety record seriously and has continuing powers after approval, which is precisely why a truthful historical declaration is more valuable to the applicant than a clean one.

3. Expert insights

Insight 1: 2 years is a lookback window, not a commitment period. The requirement looks back over the 24 months preceding submission; it does not ask the manufacturer to promise that no recall will occur in the next 2 years. The distinction matters because declarations are sometimes drafted as forward-looking assurances, which is both unverifiable and outside what is asked. The document should state a start date and an end date, and the window should be aligned to the submission date: 24 months back from the day of filing. That is the calculation. Where a filing slips by a quarter, the window moves with it, and the declaration has to be reissued rather than left at its original dates.

Insight 2: the recall statement and post-market surveillance are two ends of one chain. Section 5 requires the manufacturer or importer to monitor device performance systematically after marketing, to analyse serious adverse events and to submit vigilance reports. The recall history filed at registration is the opening record of that chain; the vigilance and recall activity after approval is its continuation. The two must be consistent. A file that declares no history and a post-market record that shows a field correction in the first year is not a documentation error but a contradiction, and it invites questions about the accuracy of the original submission. Building the declaration from the same quality records that feed the post-market system keeps the two aligned by construction.

Insight 3: the cost of concealment is far higher than the cost of disclosure. A recall history does not in itself lead to refusal, because what DGDA is assessing is the safety record, not the absence of one. But if registration declares no recall and a recall is later discovered, the character of the problem changes from a historical issue into the provision of false information, and the consequences connect to the penalty framework discussed in article 46 of this series. A disclosed recall invites questions about cause and corrective action, which are answerable. An undisclosed recall invites questions about the applicant, which are not.

Insight 4: the scope of the search is part of the declaration. Because the list of countries of sale and the CFS name the markets where the product is available, a declaration that searched only one market is inconsistent with the rest of the file. The search has to cover the markets the dossier itself claims.

4. Practical recommendations

Before issuing a recall declaration, GRZAN runs a global search to establish whether the product was subject to a recall, a field correction or a regulatory notice in any market during the preceding 24 months. The search is not limited to China, because every market named in the CFS and in the list of countries of sale counts. Where a record exists, the declaration lists the event, the cause, the corrective action and the current status. Where no record exists, we issue a written statement that there was no recall in the past 2 years. We do not recommend partial formulations such as a statement that no recall occurred in the Chinese market, because once the scope is questioned the credibility of the whole document is affected, and the reviewer’s doubt tends to extend to the rest of the dossier.

• Fix the window in writing. State both dates and tie them to the filing date.
• Search every market in the file. CFS markets and listed countries of sale define the perimeter.
• Record all three event types. Recalls, field corrections and regulatory notices all belong in the declaration.
• Use the quality system as the source. Draw the answer from complaint and CAPA records, not from memory.
• Reissue at renewal. Do not reuse the initial declaration; regenerate it on the new window.

5. Verification checklist

• □ Lookback window calculated as 24 months before the filing date, with start and end dates stated in the document
• □ Search scope covers all markets where the product is sold, not only the country of origin
• □ Where recalls exist, event, cause, corrective action and current status are listed
• □ Where no recall exists, a formal no-recall declaration is issued
• □ Document signed by the manufacturer on company letterhead
• □ At renewal, a current version issued rather than the initial registration version reused

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