Post-Market Overview
DGDA · Drug and Cosmetics Act 2023 · AR post-market obligations
The AR's Ongoing Responsibilities
Once a device is registered with the DGDA, the Authorized Representative (AR) assumes a continuing set of post-market obligations. These do not expire between registration renewals — they are ongoing throughout the device's commercial life in Bangladesh.
Summary of Post-Market Obligations
| Obligation | Responsible Party | Key Detail |
|---|---|---|
| Adverse event reporting | AR (in conjunction with manufacturer) | Report to DGDA within applicable timeframes |
| FSCAs and recalls | AR (initiated with manufacturer) | Notify DGDA before or concurrently with user notification |
| Post-market surveillance | AR + Manufacturer | Systematic collection and analysis of post-market safety data |
| Distribution records | AR/Importer | Maintain records enabling device traceability |
| Complaint handling | AR | Documented complaint handling system required |
| Registration renewal | AR | Submit renewal at least 6 months before 5-year expiry |
| Change notification | AR | Notify DGDA of significant product, labelling, or AR changes |
| Price compliance | AR | Comply with DGDA price-fixing determinations |
| Licence transfer | AR | Manage AR change process with DGDA |
| Cooperation with DGDA | AR | Assist inspections, provide records on request |
Adverse Event Reporting
Any adverse event involving a registered device that resulted — or could result — in death or serious injury must be reported to the DGDA. See Adverse Event Reporting & Recalls for full details.
Post-Market Surveillance (PMS)
The AR is expected to have a systematic process for collecting and analysing post-market safety information, including:
- Complaints from users and healthcare facilities
- Adverse event reports from users
- Published literature on device performance
- Field safety corrective actions initiated in other markets (which may indicate risks relevant to Bangladesh)
PMS data feeds into the AR's complaint handling system and informs decisions about whether an FSCA is needed.
Distribution Record-Keeping
The AR/importer must maintain distribution records sufficient to enable traceability of devices to the customer (hospital, clinic, or distributor) level. These records are critical for effective recall management. In the event of an FSCA, DGDA may request distribution records to identify affected devices.
Cooperation with DGDA Inspections
The DGDA has authority to inspect establishments and request records. The AR must:
- Cooperate fully with DGDA inspectors
- Provide access to distribution records, complaint files, and registration documentation
- Respond to DGDA queries promptly
Failure to cooperate with DGDA inspections is a serious regulatory violation subject to enforcement under the Drug and Cosmetics Act 2023, including potential Drug Court proceedings.