Medical Device and Cosmetics Act 2023 — Bangladesh's New Regulatory Framework
Bangladesh enacted the Medical Device and Cosmetics Act 2023, establishing a dedicated legislative framework for medical device regulation administered by the Directorate General of Drug Administration (DGDA) under the Ministry of Health and Family Welfare. Prior to this Act, medical devices were regulated under the Drugs Act 1940, which was poorly suited to the regulatory complexity of modern medical devices.
Key features of the 2023 framework:
- Mandatory registration: All medical devices above the lowest-risk category require DGDA registration before import or sale in Bangladesh.
- Risk-based classification: Devices are classified into risk tiers broadly aligned with IMDRF/GHTF principles.
- Local Authorised Representative: Foreign manufacturers must appoint a Bangladesh-based entity to hold the DGDA registration.
- Quality system requirements: GMP evidence or equivalent quality system certification required for higher-risk device classes.
- Post-market surveillance: Adverse event reporting and field safety corrective action obligations introduced.
📅 Effective / published: 2023 (subsidiary regulations and implementation timeline pending full commencement)
The 2023 Act represents a significant modernisation of Bangladesh's medical device regulatory landscape. However, subsidiary regulations and full implementation infrastructure are still being developed. Foreign manufacturers planning market entry should monitor DGDA announcements for implementing regulations and commencement orders, and engage a local representative who can track regulatory developments in-country.
View official source (DGDA Bangladesh) ↗