In May 2021, Hong Kong Department of Health updated the RS-01: List of Recognised Standards for Medical Devices
Medical devices listed under the Medical Device Administrative Control System (MDACS) are required to meet the Essential Principles of Safety and Performance of Medical Devices.
The Medical Device Division (MDD) believes that conformance with recognised medical device standards, in whole or in part, can provide assurance of safety and performance for those aspects of medical devices addressed by these standards. The list of recognised standards established provides a good reference for Local Responsible Persons (and their manufacturers) to demonstrate the safety, quality and performance of their products in listing applications. It also helps MDD to ensure consistency in reviewing the listing applications, and save the resources needed to review the actual test data for those aspects of the device addressed by the standards.
Nevertheless, not all requirements for listing a device may be addressed by recognised standards, especially for new types of devices and emerging technologies. In these cases, other supporting documentary evidence should be submitted for evaluation, which may involve relevant industrial or factory standards.
The updated list can be found in RS-01: List of Recognised Standards for Medical Devices, 2021