Bangladesh Medical Device Registration: Two-Step DGDA Approval and Validity
Medical device registration in Bangladesh is overseen by the Directorate General of Drug Administration (DGDA), operating under the Ministry of Health. This process was formally established and strengthened by the Drugs and Cosmetics Act, 2023 (effective September 18, 2023), which includes software and IVD reagents in its definition of a medical device.
Classification and Required Documentation
Medical devices are classified into four risk categories (A, B, C, D), closely aligning with ASEAN MDD guidelines. The required documentation varies significantly by class:
| Device Class | Risk Level | Required Documentation | Validity |
|---|
| Class A | Low | Certificate of Free Sale (CFS) from country of origin | No Expiry |
| Class B | Medium-Low | CFS from country of origin | 5 Years |
| Class C/D | Medium-High/High | CFS + EC Certificate from a Reference Country (EU, USA, Canada, Japan, Australia) | 5 Years |
Note: ISO 13485 certification is required for all Class B, C, and D devices.
The Mandatory Two-Step Registration Process
Applications for new Market Authorization Certificates for Class B, C, and D devices follow a two-step approval process with the DGDA, typically requiring 4–6 months for completion.
Step 1: Primary Review (Recipe Approval)
- Purpose: To confirm the completeness of the application with all required technical and administrative documents (submitted as PDF/Xerox copies).
- Duration: 3–4 months.
- Outcome: Issuance of a 'Recipe Approval' letter by the DGDA.
Step 2: Final Registration
- Purpose: Full review of the application and submission of original documents.
- Key Submission: Original Certificate of Free Sale (FSC) attested by the Bangladesh Embassy, and the original empty product box/label.
- Duration: 30–40 days after Step 1 completion.
- Outcome: DGDA issues the final “Registration Certificate – Medical Device/IVD Import.”
Local Representation and Labeling
Foreign manufacturers must appoint a Local Authorized Representative or Distributor to act as the License Holder. Crucially:
- Only one License Holder is permitted per device at a time.
- All devices require local labeling after customs clearance, which must prominently display the Maximum Retail Price (MRP) in Bangladeshi Taka (BDT), along with the Importer's Name, Expiry Date, and Batch/Lot number.
Benny
Our high-risk Class D cardiac stents require mandatory laboratory testing in Bangladesh as part of the registration process. How do we legally ship these samples before we have a Registration Certificate? Also, if the National Control Laboratory (NCL) does not have the specific equipment to test our specific stent coating, will DGDA accept our in-house test reports or require us to pay for a foreign lab audit?