Quality System Overview
DGDA · Drug and Cosmetics Act 2023 · ISO 13485 · GMP
Who Needs a QMS
| Entity | Requirement |
|---|---|
| Foreign manufacturer (Class B/C/D) | ISO 13485 certificate — mandatory for registration |
| Local manufacturer (Class B/C/D) | GMP compliance + DGDA manufacturing licence |
| Authorized Representative / importer | GDP-aligned storage and distribution system |
| Foreign manufacturer (Class A) | QMS recommended; ISO 13485 not mandated at Class A level |
ISO 13485 — The Core Requirement
ISO 13485:2016 is the mandatory QMS standard for foreign manufacturers of Class B, C, and D devices. The certificate must:
- Be issued by an internationally accredited certification body (IAF member accreditation)
- Cover the specific product category being registered — scope must match
- Be current at time of submission and throughout registration validity
- Be renewed before expiry — an expired certificate must be replaced before DGDA renewal
Certificates from bodies accredited only by local/national accreditation systems that are not IAF members may not be accepted by DGDA. Use an ILAC-recognised accreditation.
GMP for Local Manufacturers — BD-Unique
Bangladesh-based manufacturers must obtain a DGDA manufacturing licence which requires on-site GMP inspection. DGDA GMP requirements are broadly aligned with GHTF/IMDRF principles and ISO 13485 and cover:
- Facility design, environmental controls, and contamination prevention
- Equipment qualification and maintenance
- Personnel training and qualification records
- Document control and batch record systems
- Supplier qualification
- Internal audit programme
- Management review
See DGDA Inspections for the inspection process.
Key QMS Elements — All Entities
All establishments handling Class B/C/D medical devices must maintain:
| Element | AR / Importer | Manufacturer |
|---|---|---|
| Risk Management Plan (RMP) | Required | Required |
| Good Distribution Practice (storage/handling SOPs) | Required | Required |
| Complaint handling system | Required | Required |
| Product recall procedures | Required | Required |
| Adverse event reporting procedures | Required | Required |
| Document and record control | Required | Required |
| Internal audit | Recommended | Required |
| CAPA system | Recommended | Required |
These are reviewed during DGDA inspections.
QMS and Registration
The ISO 13485 certificate is submitted in the registration dossier (see Dossier Requirements). At renewal:
- Submit an updated, current ISO 13485 certificate
- If the manufacturer has changed certification body, ensure the new certificate covers the same product scope
- Notify DGDA if the ISO 13485 certificate is suspended or withdrawn during the registration period — this is a material change
GDP for Distribution
Good Distribution Practice covers:
- Temperature-controlled storage where required (cold chain for applicable devices)
- Segregation of quarantined, approved, and rejected stock
- Stock rotation (FIFO) to prevent expiry
- Distribution record maintenance sufficient for full traceability
- Handling procedures to prevent damage or deterioration
Bangladesh has not published a dedicated GDPMD guideline but DGDA expects standards equivalent to WHO GDP guidelines to be applied.