CE Certificate and Declaration of Conformity for Medical Device Registration in Bangladesh

CE certification and the manufacturer’s Declaration of Conformity can be important supporting evidence in a medical device registration file in Bangladesh. However, the documents serve different purposes and should be reviewed according to the device class and the current DGDA requirements.

Declaration of Conformity

A Declaration of Conformity is issued by the manufacturer to declare that the device complies with the applicable regulatory requirements and standards. DGDA’s medical device guideline states that for Class A devices, conformity assessment can generally be carried out under the manufacturer’s responsibility, and the manufacturer informs DGDA about compliance through a Declaration of Conformity.

Certification for higher-risk devices

For Classes B, C and D, DGDA applies a higher level of regulatory control. The guideline provides for notified-body certification relating to the quality management system, and for Class D, design certification is also required. Manufacturers that already have QMS, product certification or marketing authorization from a national regulatory authority or notified body outside Bangladesh should provide those documents for DGDA’s consideration.

What should be checked before submission?

The legal manufacturer name, address, device name, model or family scope and certificate validity should be checked carefully. The Declaration of Conformity and CE/notified-body documentation should correspond with the products listed in the Bangladesh application. Where certificate scope is broad, the dossier should still make the relationship to the submitted device clear.

Manufacturers should not rely on a CE mark alone without reviewing the underlying documentation. The correct combination of conformity evidence depends on the device and classification, and DGDA can request additional information during evaluation.

MedTech reviews CE, Declaration of Conformity and related certification as part of a Bangladesh registration gap assessment, helping manufacturers identify inconsistencies before submission.