The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the classification of general medical devices. The document describes in detail the applicable classification rules and highlights the most important aspects to be taken into consideration by medical device manufacturers and other parties involved. The guidance is intended to assist the parties responsible for medical devices in determining the regulatory status of their products and ensuring compliance with the applicable regulatory requirements.
Under the general rule, the severance of regulatory control should correspond to the risks associated with the use of a medical device. Consequently, medical devices with higher risk levels should be subject to additional regulatory requirements reasonably necessary to ensure their safety and effectiveness. Hence, the approach to be applied to the classification of medical devices should be based on risks associated thereto. As further explained by the HSA, the risk presented by a particular medical device depends substantially on its intended purpose and the effectiveness of the risk management techniques applied during design, manufacture, and use. The authority also acknowledges the rapid development of novel technologies and their increasing use in medical devices. In this respect, the applicable classification rules should consider the current state-of-art and provide a relevant approach allowing to establish the proper balance between ensuring the safety of medical devices allowed for marketing and use, and also ensuring the medical devices based on novel technologies could be placed on the market without undue delay.
The scope of the guidance covers any products that meet the definition of a medical device as set forth by the applicable legislation – the First Schedule of the Health Products Act, apart from in vitro diagnostic ones.
First of all, the HSA provides definitions of the most important terms and concepts used in the context of the guidance. It is important to mention that these definitions are not provided by existing legislation, hence, are non-binding in their legal nature and are provided solely to assist medical device manufacturers and other parties involved in interpreting respective regulatory requirements. The definitions provided in the guidance include, inter alia, the following ones:
- Accessory – an article that is intended specifically by its product owner to be used together with a particular medical device to enable or assist that device to be used for its intended purpose.
- Active therapeutic medical device – an active medical device used, whether alone or in combination with any other medical device, to support, modify, replace or restore biological functions or structures, with a view to the treatment or alleviation of any illness, injury, or handicap.
- Active diagnostic medical device – an active medical device used, whether alone or in combination with any other medical device, to supply information for detecting, diagnosing, or monitoring, or to provide support in the treatment of, any physiological condition, state of health, illness or congenital deformity.
Apart from the ones listed hereinabove, the document also provides definitions of such terms as “active implantable medical device”, “active medical device”, “body orifice”, “central circulatory system”, “central nervous system”, “derivative”, “harm”, “hazard”, “immediate danger”, “implantable medical device”, “intended purpose/intended use”, “invasive (body orifice) medical device”, “invasive medical device”, “life-supporting or life-sustaining”, “product owner”, “non-invasive medical device”, “non-viable”, “primary intention”, “reusable surgical instrument”, “risk”, “sterile state”, and “surgically invasive medical device”.
The document explains in detail one of the most important concepts used in the context of the classification of medical devices – the duration of use. According to the guidance, the following categories could be applied:
- Transient use – a medical device is used up to 1 hour;
- Short-term use – a medical device is used from 1 hour to 30 days;
- Long-term use – a medical device is used for more than 30 days.
In all the cases the guidance refers to “continuous use”, which stands for either uninterrupted use or accumulated use when the device is being immediately replaced with the similar one by the respective instructions for use.
The HSA further outlines the key factors to be taken into consideration when determining the applicable classification of a medical device. These factors include, inter alia, such aspects as invasiveness, the duration of use, the way the device is intended to contact the human body, and also the effect it could cause. The authority additionally emphasizes that in case the device falls within the scope of two classification rules simultaneously, the one with the higher class should be applied. In case the medical device in question tends to be used with another medical device, the applicable class should be determined for each device separately.
Special rules should be also applied in case of medical devices intended to be used in combination, namely:
- Should a product created as a result of such a combination constitute a product intended to be used for a purpose that is different from the purposes of initial medical devices, such product should be construed as a medical device itself,
- Should a combined product be intended for the same purpose as initial medical devices, its classification should be the same (in case the devices it is composed of are assigned to different classes, the highest one should be applied).
Software that is not incorporated in a medical device (standalone software application) should be treated as a separate product, and the following rules should be applied:
- Where it drives or influences the use of a separate medical device, it should be classified according to the intended purpose of the combination;
- Where it is independent of any other medical devices, it is classified in its own right using the rules;
- Standalone software is deemed to be an active medical device.
General Classification System
Under the general rules, all medical devices are divided into four classes based on the risks associated thereto, namely:
- Class A – Low risk;
- Class B – Low-moderate risk;
- Class C – Moderate-high risk;
- Class D – High risk.
In summary, the present HSA guidance provides an overview of the applicable classification rules to be applied depending on the intended purpose of a medical device, its functions, and features, duration of use, and way it should be applied. The document highlights the most important aspects to be considered when determining the class of the device and also provides specific rules to be applied for certain categories of products, such as combination products or medical software.
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