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Bangladesh Medical Device Regulation

Regulatory authority: Directorate General of Drug Administration (DGDA), Ministry of Health & Family Welfare | Primary law: Drug and Cosmetics Act, 2023 | Last reviewed: May 2026 | For reference only — not legal advice.

Bangladesh regulates medical devices through the Directorate General of Drug Administration (DGDA), operating under the Ministry of Health and Family Welfare. The primary legal framework is the Drug and Cosmetics Act, 2023 (effective 18 September 2023), which replaced the legacy Drugs Act 1940 and significantly modernised Bangladesh's approach — most notably by explicitly including software within the medical device definition.

Regulatory Pathway Map​

Click a phase to expand — each card links to the relevant section of this guide.

Getting Started
What is a Medical Device?
DGDA definition under the Drug Control Ordinance and Bangladesh medical device rules.
Read definition →
Getting Started
Regulatory Framework
How DGDA oversees medical devices — legal basis, organisational structure, and key obligations.
View framework →
Getting StartedKey step
Who Must Comply?
Registration and licensing obligations for manufacturers, importers, traders, and distributors.
Check obligations →

Key Facts​

Regulatory bodyDGDA, Ministry of Health & Family Welfare
Primary lawDrug and Cosmetics Act, 2023 (effective 18 Sep 2023)
ClassificationClass A (low) · B · C · D (high) — GHTF-based
Registration requiredClass B, C, D — mandatory · Class A — not required
Local rep requiredYes — Authorized Representative (local Bangladesh entity must hold the registration)
Registration validityClass A: perpetual · Class B/C/D: 5 years
QMS requiredISO 13485 mandatory for Class B, C, D
Review cycleQuarterly completeness review — not rolling
Average timeline4–6 months from submission

What This Site Covers​

  • Getting Started — definitions, DGDA framework, software as a device, who must comply
  • Classification — GHTF Class A–D rules, IVD classification, software, combination products
  • Registration Pathway — AR appointment, dossier requirements, quarterly review, timelines, validity
  • Pre-Market — clinical evidence by class, special device types (combination, sterile, implantable, IVDs)
  • Quality System — ISO 13485, GMP for local manufacturers, DGDA inspections
  • Digital Health — MDSW/SaMD framework, AI/ML, cybersecurity, IEC 62304
  • Post-Market — vigilance, adverse event reporting, recalls, FSCAs, PMS plan, labelling, change notifications
  • Import Licensing & Local Rep — AR framework, import licence, manufacturing licence, DGDA certificates, enforcement
  • Legislation — Drug and Cosmetics Act 2023, registration guidelines, GHTF instruments
  • Guidance & Resources — QMS requirements, essential principles, grouping rules, DGDA documents
Software is a medical device in Bangladesh

The Drug and Cosmetics Act 2023 explicitly classifies **softwa