Glossary of Key Terms
DGDA · Drug and Cosmetics Act 2023 · Reference terminology
| Term | Definition |
|---|---|
| DGDA | Directorate General of Drug Administration — Bangladesh's competent authority for drugs, medical devices, and cosmetics |
| Drug and Cosmetics Act 2023 | Primary legislation (effective 18 Sep 2023) — replaces Drugs Act 1940; includes software in device definition |
| Class A | Lowest risk class — registration not required; devices may be freely imported and sold |
| Class B | Low-moderate risk — mandatory registration (5-year validity); ISO 13485 required |
| Class C | Moderate-high risk — mandatory registration (5-year validity); ISO 13485 required |
| Class D | High risk — mandatory registration (5-year validity); ISO 13485 required; most stringent documentation |
| AR | Authorized Representative — Bangladesh-registered entity that holds the DGDA registration licence on behalf of foreign manufacturers |
| GHTF | Global Harmonization Task Force — international body whose guidance forms the basis of Bangladesh's classification system |
| FSC | Free Sale Certificate — official document from the regulatory authority of the country of manufacture confirming the device is legally sold there; required for DGDA registration |
| GMP | Good Manufacturing Practice — manufacturing quality standards verified by DGDA for local manufacturers |
| ISO 13485 | International standard for QMS for medical device manufacturers — mandatory for DGDA Class B/C/D registration |
| ISO 14971 | International standard for risk management application to medical devices |
| CPP | Certificate of Pharmaceutical Products — a WHO-format certificate; may be required by some importing countries for Bangladesh-manufactured devices |
| IVD | In Vitro Diagnostic — device intended for examination of specimens from the human body |
| SaMD | Software as a Medical Device — software with a medical intended purpose; classified as a "Drug" under the 2023 Act |
| FSCA | Field Safety Corrective Action — action taken to reduce a risk from an already-marketed device |
| FSN | Field Safety Notice — communication distributed to users in connection with an FSCA |
| Drug Court | Specialised court in Bangladesh with jurisdiction over violations of drug and device laws; a DGDA enforcement mechanism |
| Drug Rules 1946 | Subsidiary legislation under the old Drugs Act; some provisions continue to apply pending new rules under the 2023 Act |
| Quarterly Review | DGDA's process of assessing application completeness on a quarterly (not rolling) basis — unique to Bangladesh |