Local Responsible Person (LRP)
HK-unique framework · LRP is the key accountability holder
Who Can Be an LRP?
Any Hong Kong-registered company or sole proprietorship, including:
- The HK distributor appointed as LRP
- A dedicated regulatory affairs service provider
- A locally registered subsidiary of the manufacturer
Requirements: HK registered business address; technical capacity to fulfil LRP obligations.
Pre-Market Obligations
| Obligation | Detail |
|---|---|
| Listing application | Submit and manage MDACS listing via MDIS |
| Documentation | Compile and hold technical dossier |
| Labelling | Ensure HK labelling (bilingual where required) is compliant |
| MDD queries | Respond to queries during MDD review |
Post-Market Obligations
| Obligation | Detail |
|---|---|
| Adverse event reporting | Report within 10 or 30 days as applicable |
| FSCA coordination | Initiate and coordinate FSCAs |
| Complaint handling | Maintain documented complaint handling system |
| Device tracking | Track specified devices to user level |
| Change notification | Notify MDD of significant changes |
| MDD cooperation | Assist MDD-initiated investigations |