Mandatory medical devices to be registered in DGDA Bangladesh

Directorate General of Drug Administration (DGDA), Bangladesh controls and regulates the medical devices, equipment, software as medical device, IVD reagent and instrument by the Drug and cosmetics act 2023 and the Medical device guideline of Bangladesh 2015:

1. Adhesive surgical dressing
2. Ablation device
3. Balloon dilatation catheter
4. BiPAP machine
5. Biopsy needle
6. Bilirubin Perfusion Adsorption Column
7. Blood line
8. Blood bag
9. Blood glucose monitoring system, Glucometer
10. Coronary stents
11. Cardiac Pacemaker
12. Catheter
13. cPAP machine
14. CT Scan machine – Computed Tomography imaging system
15. Dialyzer – Haemodialyzer
16. Diagnostic ultrasound system
17. Dialysis equipment
18. Hematology analyzer
19. Hemorrhoid stapler
20. MRI Machine
21. Needle
22. Ophthalmic lens
23. Orthopedic implants
24. Robotic surgical equipment
25. Surgical suture
26. Surgical tape
27. Surgical stapler, cutter
28. Syringe
29. Urine Bag
30. X-Ray Machine
31. X-Ray film