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 |
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Hong Kong Approval Process for Medical Devices
Medical devices in Hong Kong are regulated by the Medical Device Control Office (MDCO).Though the decision to register devices in Hong Kong is volu
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Hong Kong Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for Hong Kong.
read more