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Bangladesh Medical Device Regulations

Agency
The Directorate General of Drug Administration (DGDA) regulates medical devices in Bangladesh.
Medical Device Definition
A medical device in Bangladesh 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;
The device must not use pharmacological, immunological, or metabolic means to perform its primary function, although it may be assisted by such means. It shall be deemed to be a Device under the meaning of Section (3)b (ii), (iii), and (v) of the Drugs Act 1940.
Medical Device Classification System
International Classification Risk Level Examples
Class A Low Risk Surgical retractors, tongue depressors
Class B Low–moderate risk Hypodermic Needles, suction equipment
Class C High- Moderate ris Lung ventilator, bone fixation plate
Class D High risk Heart valves, implantable defibrillator
Approval Process
Classification Approval procedure
Class A
  • The manufacturers are not required to obtain manufacturing license from DGDA.
  • The manufacturers shall inform DGDA about compliance by way of Declaration of Conformity.
Class B
  • An authorized representative should be appointed.
  • For Classes B, C and D, certification by a notified body with reference to QMS is required.
  • For Class D, certification for the design of the device(s) is required.
  • Manufacturers who have already gone through the Quality Management System (QMS) and have product certification and/or marketing authorization from a National Regulatory Authority or Notified body outside of Bangladesh must produce those documents.
  • A free sale certificate (FSC) for Class B (from the country of origin), Class C and Class D (from any one of the countries – EU, USA, Canada,Australia and Japan and from the country of origin) should be submitted.
  • The registration will be granted by DGDA based on these documents and any necessary inspections.
  • Manufacturers and/or importers must submit registration applications and the DGDA-required supporting documentation.
Class C
Class D
Additional Information
Approval timeline Class A:- 1 month Class B, C, & D:- 3 to 12 months Approx.
License validity period Does not expire if the license retention fee is paid (every 2 years)
Fees Any Medical device registration :- $550 - $600
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