What manufacturers should know about the commonly referenced five-year registration validity and preparing a DGDA renewal package.
Bangladesh medical device registration is generally referenced as having a 5-year validity period. The registration holder should track the certificate expiry date and begin renewal preparation early.
Published regulatory guidance includes the Letter of Authorization and agency agreement, applicable EC/CE certificate, attested Free Sale Certificate, recall-history information, original packaging or label, existing registration certificate and warehouse-license documentation. Additional documentation may apply to Class C and D products.
Review whether the manufacturer name, product labeling, models or regulatory certificates have changed since the original registration.
MedTech supports manufacturers with regulatory documentation, registration and Bangladesh market access. Requirements may change, so confirm the current DGDA requirements for your specific product before submission.
