Tag Archive for: hong kong

Hong Kong MDD Issues New Technical Reference Document for AI-MD

On January 3, 2024, Hong Kong’s Medical Device Division (MDD) issues the Technical Reference document TR-008: Artificial Intelligence Medical Devices (AI-MD). It provides clarity for devices using AI (AI-MD) and machine learning, including Continuous Learning Capability (CLC) and the technical requirements expected for listing these medical devices on the Medical Device Administrative Control System (MDACS).

Hong Kong MDD Issues Technical Reference for SaMD and SiMD

Hong Kong’s Medical Device Division has released a new technical reference document related to software medical devices (SaMD and SiMD). Released on December 29, 2023, TR-007: Software Medical Devices and Cybersecurity, aims to provide more clarity for Software in a Medical Device (SiMD) and standalone software (Software as a Medical Device (SaMD)), specifically related to definitions, classification and cybersecurity. 

Hong Kong Refines Medical Device Post-Market Surveillance Report Form

On December 29th, 2022, the Hong Kong Medical Device Division refined and updated their Post-Market Surveillance Report form.

MDD Issues Guidance on Making Changes to Medical Device Licenses in Hong Kong

On November 30th, the Hong Kong Medical Device Division (MDD) issued formal guidance on the requirements to make changes to medical device licenses registered in the Medical Device Administrative Control System (MDACS).

Hong Kong Government Prioritizes Purchase of Locally Registered Medical Devices

The Department of Health (DH) in Hong Kong has announced a new strategy for the procurement of medical devices (MDs), effective from June 21, 2023.


By allowing manufacturers to show conformity to the MDD’s assessment requirements by using NMPA or MFDS approvals, Chinese and Korean manufacturers would save 6-9 months during the application process.

Voluntary Medical Device Registration in Hong Kong

Medical device manufacturers that are serious about growing sales in Hong Kong/Southeast Asia should consider registration a mandatory step.