Starting from 2 April 2024, the Medical Device Division (MDD) accepts the marketing approvals obtained from the Health Sciences Authority (HSA) of Singapore as a support of compliance of medical device to the "Essential Principles of Safety and Performance of Medical Devices" (Technical Reference: TR-004) under MDACS.
The following updated Guidance Notes and application forms in response to the above changes are uploaded to our website (www.mdd.gov.hk):