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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 devices
  • 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​

ClassAdditional Documentation
BISO 13485 certificate sufficient; shorter clinical evaluation acceptable
CMore detailed clinical evaluation expected; design history documentation
DComprehensive 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 TypeEligibility
Same manufacturer + same intended purpose + shared design principlesMay qualify for single application
Systems (devices used together as an integrated system)May qualify
Procedure packsMay 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.