Bangladesh Medical Device Regulations

Agency
All medical devices are regulated by the Directorate General of Drug Administration (DGDA).
Medical Device Definition
Medical deviceTM means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury, investigation, replacement, modification, or support of the anatomy or of a physiological process, supporting or sustaining life, control of conception, disinfection of medical devices, providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means shall be deemed to be a Device under the meaning of Section (3)b (ii), (iii) and (v) of the Drugs Act 1940
Classification of Medical Device
International Classification Examples Risk Level
A Surgical retractors / tongue depressors Low
B Hypodermic Needles / suction equipment Low - Moderate
C Lung ventilator / bone fixation plate High - Moderate
D Heart valves / implantable defibrillator High
Premarket Approval Process
A B C D
Appoint an authorized representative (AR) in Bangladesh
Pay application fee
Fill out application form and submit all required documents including information about device, marketing details, combination information, etc
If approved, applicant will receive a registration certificate
Additional Information
Postmarket Surveillance Implementation of post market surveillance systems, adverse incident reporting programs and vigilance activities.
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