The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published revised guidance on the classification of general medical devices. The document is intended to provide additional clarifications concerning the risk-based classification of medical devices applied in the country, as well as recommendations to be considered by medical device manufacturers when determining the class of the product before applying for registration and placing it on the market. It is important to mention that provisions of the guidance are non-binding, so the document is not intended to introduce new rules and requirements to be followed.
Risk Class Determination
The guidance describes in detail the approach to be applied by medical device manufacturers and other parties involved when determining the class of a medical device under the risk-based classification. According to the document, a party responsible for the product should:
- Decide if the product concerned is a medical device, using the appropriate definition;
- Document the intended purpose of the medical device; and
- Take into consideration all the rules that follow to establish the proper risk classification for the device, noting that where a medical device has features that place it into more than one risk class, risk classification should be based on the highest risk class applicable.
The authority also mentions that in vitro diagnostic medical devices are falling outside the scope of the present guidance since the approach to be applied to such products is slightly different.
Risk-Based Classification Rules
Under the general rule, the classification of a medical device should be based on its design, and also on the functionality and intended purpose indicated by its manufacturer (i.e., the claims made by the manufacturer in documentation accompanying a device). To assist medical device manufacturers and other parties involved in applying the respective classification rules, the HSA provides a table covering the main classification rules and the way they should be applied. However, the authority also states that each case should be considered separately.
- Non-invasive medical devices. The first group of classification rules applies to non-invasive medical devices.
- Depending on the intended use, non-invasive devices contacting injured skin could be either Class A devices (in case they are used as a barrier), or Class B – in case they are intended to manage the microenvironment of the wound; while the products intended to treat the wound are Class C medical devices.
- Devices intended for administering medicines or channeling or storing body liquids are Class A medical devices; unless they are intended to be connected to an active medical device in Class B or a higher class, in which case they are in Class B. For instance, this rule applies to administration sets for infusion pumps.
- Non-invasive devices intended for channeling blood or its components or storing organs or their parts, are Class B medical devices; except the blood bags, which are Class C devices.
- Non-invasive devices intended to modify the composition of the blood or other body liquids are Class C medical devices; except the cases when these modifications are achieved by filtration or centrifugation, as then they will be Class B devices.
- All non-invasive medical devices that are not intended to contact injured skin are Class A medical devices.
- Invasive devices. The guidance further provides an overview of the classification rules to be applied in the case of invasive medical devices.
- Invasive devices using body orifices (the ones that are not surgically invasive), and are not intended to be connected to an active medical device or are intended to be connected to a Class A medical device only, are Class A medical devices, except certain specific cases when they are Class B devices. Another criterion to be taken into consideration is the duration of use, as this also impacts the classification: products intended for transient use are Class A medical devices, the ones intended for short-term use are mostly Class B devices, and the products intended for long-term use are Class C devices (except certain exclusions when they are Class B products).
- All invasive devices that are intended to be connected to an active medical device assigned to Class B or higher, are Class B medical devices themselves.
- All surgically invasive devices intended for transient use are in Class B. According to the guidance, this rule applies to several groups of medical devices, including surgical instruments, surgical staplers, surgical gloves and also catheters, and other similar products. The authority also mentions that reusable surgical instruments are Class A medical devices, while the single-use ones (supplied sterile) are Class B devices. Should the product in question contain medicinal substances, a different rule should be applied.
- Medical devices intended to administer medicines in a way that could create hazards to the patient are Class C medical devices. This rule applies, inter alia, to insulin pens for self-administration. As further explained by the HSA, for this rule, the term “administration of medicines” implies storage and/or influencing the rate/volume of medicine delivered, not just channeling.
- Medical devices intended to contact the central nervous system, as well as the ones intended to diagnose or impact the central circulatory system are Class D medical devices.
- Most of the surgically invasive medical devices intended for short-term use are Class B medical devices, except for certain exclusions described in the guidance. For example, should these devices be intended to administer medicinal products, they should be considered Class C devices. The same class should be applied in case the device in question is intended to undergo chemical change in the body. Should the device be intended to have a biological effect, such a device should be assigned to Class D.
Apart from invasive and non-invasive medical devices, the document also describes in detail the classification rules to be applied in the case of active devices; and also covers additional rules addressing certain specific cases.
Additionally, the document provides several flowcharts and diagrams illustrating the way the approach described hereinabove should be applied when determining the class of the product subject to review. However, the authority also mentions that these diagrams should not be considered exhaustive, and are provided merely to assist medical device manufacturers in interpreting existing classification rules and their main principles.
In summary, the present HSA guidance covers the most important aspects related to the existing risk-based classification system for medical devices. The document provides a brief overview of the applicable classification rules and emphasizes the key points to be considered about each of the rules.
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