Bangladesh Medical Device Registration

Navigating the Regulatory Landscape: An Insight into Medical Device Regulations in Bangladesh

Overview of Medical Device Status in Bangladesh

Starting from September 18, 2023, the Drug and Cosmetics Act, 2023, introduced by the Government of Bangladesh, has officially outlined the stipulations for medical devices and in vitro diagnostic (IVD) reagents. Notably, the definition of medical devices has been expanded to include software, which is now categorized under Drugs in the regulations.

Regulatory Authority

Directorate General of Drug Administration (DGDA)

The Directorate General of Drug Administration (DGDA) is responsible for ensuring the quality, safety, efficacy, and safety of pharmaceutical products through the implementation of relevant legislation. Its responsibilities include ensuring the availability and affordability of essential drugs, evaluating new projects, issuing, and renewing drug manufacturing licenses, and registering and renewing drug products.

They also fix and certification prices for drug products, inspect pharmaceutical establishments, approve block lists for import of raw and packaging materials, and indent for import of finished drugs.

Surveillance and pharmacovigilance activities are also carried out.

The DGDA also prosecutes cases in drug courts and other courts, and issues export licenses, FSC (Free Sales Certificate), GMP (Good Manufacturing Practices) Certificate, and CPP (Certificate for Pharmaceutical Products).The organization aims to meet the needs of the people by ensuring the safety, efficacy, and quality of medicines.

Link for Regulatory Authority

Home (dgda.gov.bd)

Local Regulation

Drugs Act, 1940

Classification of Medical Devices Class Risk-Level Example Class A Low Surgical retractors / tongue depressors Class B Low-Moderate Hypodermic Needles / suction equipment Class C Moderate- High Lung ventilator / bone fixation plate Class D High Heart valves / implantable defibrillator

Documents Required for Registration

Agency agreement or nomination of local agent
Details Company Profile 3. Complete Product Dossier including:

Manufacturing Procedure
QC & QA procedure with the name of technical personnel
Sterilization procedure
Clinical trial documents
Product recall procedure
Plant lay with floor plan etc. documents.

Attested copies of CPP/FSC of Country of Origin attested by Bangladeshi Embassy
English and Bengali version of the printed packaging materials and Dossier
Test protocol and analytical certificate
Complete packaging materials of the devices mentioning manufacturers name & address, batch/lot no., specification & size, Manufacturing date, expiry date, Sterility status
Required blister packing/ribbon packing for disposable syringe
Complete Annexure 3 form (to be completed after getting the above-mentioned documents)
EC Certificate
Declaration of Conformity/Conformity assessment.

License Validity

Class A Licenses do not expire, Licenses of Class B, C, and D are initially valid for a period of 5 years. Renewal of these licenses can be processed within approximately 2 to 3 months.