Registration Dossier Requirements
DGDA · Registration Guidelines · Class B/C/D dossier
Common Requirements — All Class B, C, D
All Class B, C, D registrations require the following core documentation:
1. Application Form
The DGDA-prescribed application form, completed in full by the AR. Available from the DGDA website or office.
2. Company Profile and AR Documentation
- AR company registration certificate (Trade Licence, TIN, VAT registration)
- Letter of Authorization from the legal manufacturer formally appointing the AR
- Organogram/company details of the AR
3. Device Description and Specifications
- Full trade name and model name(s)
- Intended use/intended purpose as stated by the manufacturer
- Principle of operation
- Materials of construction (device and packaging)
- Physical dimensions and specifications
- Configuration/variants covered by the application
4. ISO 13485 Certificate — BD-Unique Mandatory
- Current and valid ISO 13485:2016 certificate from an accredited certification body
- Must cover the specific product category being registered
- Scope must be appropriate — a certificate for "surgical instruments" does not cover active implantable (or 2023) devices, Class D high-risk devices, or IVDs unless explicitly stated ILAC-accredited and recognised certification bodies. Certificates from unaccredited or locally-only accredited certification bodies may not be accepted.
- DGDA recognises certificates from internationally accredited CBs
5. Free Sale Certificate (FSC)
- Issued by the regulatory authority of the country of manufacture (not just a trade body)
- Confirms the device is legally marketed in its home country
- Must be current — DGDA will check validity
- If the device is manufactured in a country without a formal market authorisation system, contact the DGDA for guidance
6. Risk Management Documentation
- Summary of the ISO 14971 risk management process applied to the device
- Key hazard identification, risk estimation, risk control measures, residual risk evaluation
- Conclusion that benefits outweigh residual risks
- The full ISO 14971 risk management file is held by the manufacturer; a comprehensive summary is included in the dossier
7. Clinical / Performance Evaluation Evidence
- For Class B/C: clinical evaluation summary or equivalent data demonstrating safety and performance
- For Class D: comprehensive clinical evidence — often a Clinical Evaluation Report (CER) aligned with the reference-country dossier
- IVDs: performance evaluation data (sensitivity, specificity, precision, accuracy, stability)
- Overseas clinical data is acceptable where the device and patient population are equivalent
8. Labelling and IFU
- Proposed label and Instructions for Use (IFU) in English
- Bengali translation required where the device is intended for lay users
- Must comply with DGDA labelling requirements (see Labelling Requirements)
9. GMP Evidence
- Evidence of manufacturing site compliance with Good Manufacturing Practice
- Acceptable forms: ISO 13485 certificate covering the manufacturing site; GMP inspection report from a recognised regulatory authority
Additional Requirements by Class
| Class | Additional Documentation |
|---|---|
| B | ISO 13485 certificate sufficient; shorter clinical evaluation acceptable |
| C | More detailed clinical evaluation expected; design history documentation |
| D | Comprehensive clinical data — often aligned with FDA PMA, CE MDR, or TGA dossier; full design documentation; manufacturing process details |
Certificate of Pharmaceutical Products (CPP)
The CPP (WHO format) may be required for certain device categories, particularly where the DGDA requests confirmation of the product's pharmaceutical-adjacent regulatory status. Confirm with the DGDA whether a CPP is needed for your specific device type.
Grouping Applications — BD-Unique
Multiple devices may be included in a single DGDA application if they form a legitimate group:
| Group Type | Eligibility |
|---|---|
| Same manufacturer + same intended purpose + shared design principles | May qualify for single application |
| Systems (devices used together as an integrated system) | May qualify |
| Procedure packs | May qualify if components share a common procedure |
Confirm grouping eligibility with the DGDA or your AR before preparing a grouped application. Note that while grouping reduces the number of applications, each device in the group must meet all applicable requirements.
Supporting Documents — Practical Tips
- Notarisation and apostille: Some supporting documents from overseas may require notarisation or apostille authentication. Check with the DGDA and the relevant embassy/consulate.
- Document currency: All certificates and regulatory approvals must be current at the time of submission. An expired ISO 13485 certificate will cause the application to fail completeness review.
- Language: Documents in languages other than English require certified translation.
- Consistency: Ensure the device name, model number, and specifications are consistent across all submitted documents — inconsistencies are a common cause of completeness failures.
Confirm grouping eligibility with the DGDA before submitting a grouped application. Grouped applications must demonstrate clear linkage between devices and shared safety/performance characteristics.
Free Sale Certificate (FSC) — Acceptance Criteria:
The FSC must be:
- Issued by the regulatory authority of the country of manufacture (e.g., FDA, EMA, TGA, Health Canada, PMDA)
- Current and valid at the time of DGDA submission
- Issued within the past 2 years (confirm current DGDA requirement)
- In English or with a certified English translation
- Specifically naming the device model(s) being registered in Bangladesh
FSCs issued by trade associations, industry bodies, or non-regulatory entities are not acceptable. If the country of manufacture has no formal market authorisation system, contact the DGDA in writing to request alternative evidence of market authorisation or equivalency.
Grouping Applications — BD-Unique (continued):
Multiple devices may be included in a single DGDA application if they form a legitimate group:
| Group Type | Eligibility |
|---|---|
| Same manufacturer + same intended purpose + shared design principles | May qualify for grouped registration if devices differ only in size, material specifications, or configuration variants |
| Different manufacturers | Not eligible for grouping |
| Different intended purposes | Not eligible for grouping |
| Different risk classes | Not eligible for grouping |
Grouping must be justified in the application with a summary demonstrating why devices are sufficiently similar that a single risk management file and clinical evaluation can appropriately support all devices in the group. The highest risk device in the group determines the classification of the entire group. Contact the DGDA early if you intend to group devices to confirm eligibility.