| Regulatory Authority | Directorate General of Drug Administration |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | A,B,C,D |
| Medical Device Regulations | Registration Guidelines for Medical Devices Bangladesh 2015 (Same Regulations for IVD) | Click Here |
| IVD Classification | A,B,C,D |
| In Vitro Diagnostics Regulations | http://dgdagov.info/index.php/information-center/guidance-documents/1135-medical-device-registration-guideline-2015/file |
| Registration Process | Annexure 2 of Registration Guidelines for Medical Devices Bangladesh 2015 |
| Registration Timeline | For class A, it takes 1 month and other classes depends on notified body. |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in Arabic or English language |
| Additional Information | The manufacturer of a Class A device shall inform DGDA about compliance by way of Declaration of Conformity. For device(s) falling under Classes B, C and Class D certification by a notified body with regard to QMS and in case of Class D certification for the design of the device(s) is required |