Skip to main content

Post-Registration Changes

DGDA · Variation · AR change · BD-Unique

Overview​

Any significant change to a DGDA-registered medical device must be reviewed and approved by the DGDA before implementation. Implementing changes without DGDA approval is a regulatory violation and may lead to enforcement action.

What Constitutes a Significant Change​

The following changes generally require a variation application to DGDA:

Change TypeVariation Required
Device design or specification change✅ Yes
Change in intended use / indications✅ Yes
New contraindication or warning✅ Yes
Manufacturing site change✅ Yes
Change of manufacturer✅ Yes
Labelling change (safety-critical)✅ Yes
Change of Authorized Representative✅ Yes — see below
ISO 13485 certificate change (new CB)Notify DGDA
Administrative / contact detail changeNotify DGDA

Minor changes with no impact on safety or performance may be handled by notification rather than full variation — confirm with DGDA for your specific change.

Variation Application Process​

  1. Prepare variation documentation — description of the change, reason, supporting evidence (updated technical documentation, risk assessment, updated dossier sections)
  2. Submit the variation application to DGDA (through the AR)
  3. DGDA reviews the variation — timeline depends on the nature and complexity of the change
  4. DGDA approves or rejects the variation; may request additional information
  5. Implement the change only after DGDA approval is received

Do not implement a significant change before DGDA approval — even if a change is clearly an improvement, proceeding without approval is a compliance violation.

Changing the Authorized Representative​

If the AR changes (due to business reasons, termination of AR relationship, or AR company dissolution):

  1. The new AR must be a DGDA-licensed entity with a valid trade licence and import licence
  2. The outgoing and incoming ARs must cooperate to transfer all registration documentation and post-market records
  3. A formal variation/transfer application is submitted to DGDA by the incoming AR
  4. DGDA updates the registration to reflect the new AR
  5. The incoming AR assumes all regulatory obligations from the transfer date

Avoid gaps in AR coverage — a device without a valid AR in Bangladesh cannot be legally distributed. Plan AR transitions with sufficient lead time.

Labelling Changes​

Labelling changes that affect safety information (new warnings, changed contraindications, revised intended use) require variation approval. Administrative labelling changes (updated distributor address, formatting) may be handled by notification — confirm with DGDA.

Implement approved labelling changes promptly. Continuing to distribute devices with superseded labelling after an approved change is in force is a compliance issue.

Changes Driven by Other Markets​

If a major regulatory authority (FDA, EMA, TGA) requires a labelling change or design change for safety reasons, assess whether the same change is required for the Bangladesh registration. Safety-driven changes required in major markets should generally be applied to the Bangladesh-registered device as well, with a variation application submitted to DGDA.

FSCA-Triggered Changes​

If a post-market safety event leads to a product modification or labelling change, the FSCA process and the variation process run in parallel:

  • Implement the FSCA as required to address the immediate safety risk
  • Submit a variation application to formalise the change in the DGDA registration

See Adverse Event Reporting & Recalls for the FSCA process.