The Singapore classification system is based on GHTF guidance. Risk can be dependent on the intended use, effectiveness of risk management during the design and manufacturing process, degree of invasiveness, delivery method, duration of contact, intended users, and technologies.
Products are classified into one of the following, from lowest to highest risk:
IVD products are also classified into one of the following, from lowest to highest risk:
Risk is determined by intended use, the expertise of the intended user, the importance of the resulting information of the diagnostic, and the impact of the test results. For example, a pregnancy test is Class B whereas an HIV Blood Test is Class D.
The HSA has an online tool to help determine the risk classification for your general MD or IVD.
If stand-alone software can be defined as a medical device, then it will be classified depending on the following:
If it influences the use of another medical device, then the classification will be determined by the intended use of the combined products
If it is independent from any medical device, then it will be classified according to the Singapore classification rules
Stand-alone software is considered an active device and this can also affect its classification
To learn more about Singapore’s software requirements, please review our blog on the subject.
Medical devices intended for telehealth or modification of appearance/anatomy (aesthetic-related intended purpose) has different regulatory requirements.
For telehealth, risk can range from A to C, and it is dependent on the intended purpose. A Class A device could be a software or app that does not monitor patient parameters and only displays physiological factors recorded from another device, such as a patient monitor. A Class B device could measure single parameters such as heart rate, ECG, blood glucose level, etc. A Class C device is used for apps/software that can be used to live and/or continuous measurement such as an irregular heart rate.
For devices meant for modification of appearance or anatomy, only high-risk products will be regulated. These devices are listed in Annex A positive list and will updated over time. The current list is the following:
Any implant for the modification of fixation of any body part
Any injectable dermal filler or mucous membrane filler
Any instrument, apparatus, implement, machine, or appliance intended to be used for the removal or degradation of fat by invasive means
Contact Asia Actual for more information about the Singapore classification system.