Class A Medical Device Declaration in Bangladesh

Class A medical devices are generally low-risk products. In Bangladesh, the Directorate General of Drug Administration (DGDA) uses a risk-based system that divides medical devices into Classes A, B, C and D. Correct classification should be confirmed before preparing a declaration or registration file because the regulatory route depends on the device risk and intended use.

How Class A devices are handled

Under the DGDA medical device guideline, conformity assessment for a Class A device can generally be carried out under the manufacturer’s responsibility because of the lower risk involved. The manufacturer informs DGDA about compliance through a Declaration of Conformity. This differs from Classes B, C and D, where registration and additional conformity evidence are required.

Documents commonly prepared

For an imported Class A device, the submission should be prepared according to the current DGDA checklist and the specific product. Typical supporting documents may include the manufacturer’s authorization for the Bangladesh representative, Free Sale Certificate from the manufacturing country, Declaration of Conformity, product catalogue and relevant product information. DGDA may request additional evidence depending on the device and its classification.

Before submitting

Do not assume a device is Class A only because it appears simple. Classification considers intended use, duration of contact, invasiveness, whether the device is active, and other risk factors. A wrong classification can lead to an incorrect submission route and unnecessary delay.

Foreign manufacturers should also ensure that the manufacturer name, product identity, models and supporting certificates are consistent throughout the dossier. Where a local representative is used, the authorization documents should clearly cover the products being submitted.

MedTech supports manufacturers with classification review, document gap assessment and preparation of Class A medical device submissions in Bangladesh. For a product-specific assessment, contact us before finalizing the dossier.