Bangladesh Medical Device Regulation

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

 Updated on 19/01/24 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:

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.

 Registration Fee:As of October 2023, the total fees for a first-time registration in Bangladesh amount to approximately US$600. For amendments to existing registrations, the fees stand at US$120.
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, and a renewal fee of approximately USD 120 is applicable.

 Who should make this communication:

• Manufacturer
• Authorized Representative

When to make this communication: Before placing a medical device into the market.

How OMC Medical can assist you with the process

• Act as your Authorized representative

Why Choose Us

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: [email protected] https://www.worldexindia.com/medhealthexpos/bdmhve/assets/pdf/medica-device-guideline-annexure.pdf https://www.regdesk.co/resource-library/bangladesh/