Hong Kong Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for Hong Kong.
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Classification Rules for Medical Devices | TR-003 | 1/2010 | English |
| Log in | Overview of the Hong Kong Medical Device Administrative Control System | GN-01 | 9/2005 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Conformity Assessment Framework and Conformity Assessment Bodies | GN-04 | 2006 | English |
| Log in | Code of Practice for Local Responsible Persons | COP-01 | 9/2005 | English |
| Log in | STED Format for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) | TR-002 | 10/2006 | English |
| Log in | Additional Medical Device Labelling Requirements | TR-005 | 4/2010 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Guidance Notes for Adverse Incident Reporting by Local Responsible Persons (LRP) | GN-03 | 2021 | English |
| Log in | Principles of In Vitro Diagnostic (IVD) Medical Devices Classification | TR-006 | 12/2009 | English |
| Log in | Guidance Notes for Listing Class B, C, and D In Vitro Diagnostic (IVD) Medical Devices | GN-06 | 2021 | English |
| Log in | Guidance Notes for Listing Class II-III-IV Medical Devices | GN-02 | 2021 | English |
