Hong Kong’s Medical Device Control Office (MDCO) issued two regulatory documents on January 4, 2010. One document is the Guidance Notes GN-00: Definitions and Abbreviations for the Medical Device Administration Control System (MDACS). The other document is Technical Reference TR-003: Classification Rules for Medical Devices. TR-003 replaces Appendix I of the Guidance Notes GN-01.
TR-003 is adapted from the GHTF/SG1-N15:2005 document where medical devices are classified according to risk. A Class I medical device will have the lowest risk while a Class IV medical device will have the highest risk.
If, based on the manufacturer’s intended purpose, two or more classification rules apply to the device, then the product will be given the highest classification level. Medical devices used with each other will be classified depending on the purpose. For example, if the combination serves a different purpose than that of the individual devices, then the combination is a new medical device in its own right and should be classified according to its new intended use. If the combination is for the convenience of the user but does not change the intended use of the individual medical devices, then the classification will be given based on the highest classified device in the combination.
Accessories to be used together with a ‘parent’ medical device will be classified as though it is a medical device in its own right. Standalone medical software will also be classified accordingly, depending on whether it is independent of any other medical device or influences the use of a separate medical device.
The MDCO has provided a chart in document TR-003 to help manufacturers determine their medical device classification.
GN-00 is primarily an updated list of terms and definitions used throughout the MDACS guidance documents.