Medical Device Regulatory Requirements in Hong Kong
| Regulatory Authority |
Medical Device Division |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, II, III, IV |
| Medical Device Regulations |
Currently, there is no specific legislation that regulates the manufacture, import, export and sale of medical devices in Hong Kong. |
| IVD Classification |
A,B,C,D |
| Registration Process |
Guidance Notes for Listing Class II/III/IV General Medical Devices
| Click Here
|
| Language Requirement |
Labels must be in both English and Chinese Language |
| Database |
Medical Device Administrative Control System
| Click Here
|
| Adverse Event Reporting Form |
Download |
| Additional Information |
In order to enable traders to familiarise themselves with the future mandatory requirements, Department of Health (DH) has established the Medical Device Administrative Control System (MDACS), which includes a listing system for Class II/III/IV general MDs and B/C/D in vitro diagnostic medical devices (IVDMDs). Class I general MDs and Class A IVDMDs are not under the current scope of the MDACS. Moreover, MD traders can join MDACS as Listed Local Manufacturers, Listed Distributors and Listed Importers. More detailed information regarding MDACS is available on our website ( https://www.mdd.gov.hk/en/home/index.html ). |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025