Bangladesh Medical Device Regulations

Regulatory Agency

The Directorate General of Drug Administration (DGDA) regulates medical devices in Bangladesh.

Medical Device Definition

Medical Device: 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.

Active medical device: Any medical device, operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patients, without any significant change, are not considered to be active medical devices. Standalone software that fulfills the attributes of the definition of “medical device” above is deemed to be an active medical device.

Active therapeutic device: Any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or handicap.

Active device intended for diagnosis: Any active medical device, whether used alone or in combination with other medical devices, to supply information for detecting, diagnosing, monitoring or to support in treating physiological conditions, states of health, illnesses or congenital deformities.

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

Regulatory 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: 3-4 months, Class C & D: 4-6 months
License validity period	Does not expire if the license retention fee is paid
Fees	Any Medical device registration :- $700- $800