Directorate General of Drug Administration (DGDA) - Bangladesh

The Directorate General of Drug Administration (DGDA) is the national regulatory authority (NRA) under the Ministry of Health and Family Welfare of Bangladesh. It is responsible for the regulation of all health products, including drugs, vaccines, and medical devices.

1. Regulatory Role

DGDA oversees the import, manufacture, sale, and distribution of medical devices in Bangladesh. Its primary goal is to ensure that all medical devices are safe, effective, and meet international quality standards before they reach the public.

2. Legal Framework

Medical device regulation in Bangladesh is primarily governed by:

• The Drugs Act, 1940
• The Drugs (Control) Ordinance, 1982
• Registration of Medical Device Guidelines, 2015: These guidelines provide the specific procedures for the registration and classification of medical devices based on risk.

3. Key Functions

• Product Registration: DGDA maintains a registered list of medical devices. No device can be imported or manufactured without prior registration or a No Objection Certificate (NOC).
• Licensing: Issuing licenses to manufacturers and importers.
• Quality Control: Monitoring quality through inspections and laboratory testing.
• Vigilance: Tracking adverse events and managing product recalls when safety issues arise.

4. Classification

Bangladesh follows a risk-based classification system (Classes A, B, C, and D), aligning with Global Harmonization Task Force (GHTF) principles, where Class A represents low risk and Class D represents high risk.