The new article addresses the aspects related to the existing classification rules for non-invasive medical devices and the way they should be applied based on the device, its intended use, and other factors.
Table of Contents
The South African Health Products Regulatory Authority (SAHPRA), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the classification of general and in vitro diagnostic (IVD) medical devices. The document describes in detail the approach to be applied when determining the class of a medical device under the existing classification rules and also provides additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved in operations with medical devices in order to ensure compliance thereto. At the same time, provisions of the guidance and recommendations provided therein are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Furthermore, the authority reserves the right to make changes thereto, should such changes be reasonably necessary to reflect corresponding changes to the underlying legislation.
In particular, the document describes in detail specific criteria to be applied when determining the class of the device and factors to be considered.
Duration of Use
According to the guidance, when determining the class of a medical device subject to review, one of the main factors to be taken into consideration is the duration of use. As the authority explained, using a medical device could be transient, short-term, and long-term. Transient stands for the use that lasts less than 1 hour; short-term applies to the use between 1 hour and 30 days, while everything above 30 days is considered a long-term use.
Non-invasive Devices: Classification
The document further describes in detail special rules to be applied with respect to non-invasive medical devices. The document also provides a flowchart illustrating the way the respective approach should be followed. The said flowchart is based on the rules and criteria reflecting the intended use of the device and the way it is expected to be used (for example, in connection to an active medical device).
The first classification rule applies to non-invasive medical devices intended to have contact with injured skin (for this rule, the wound depth is not something considered, while the technology used is well-known and is not expected to expose patients to additional hazards). For instance, according to the classification rule, non-invasive medical devices intended to be used as a mechanical barrier or for compensation or absorption of exudates are Class A medical devices. This rule applies, inter alia, to absorbent pads and cotton wool. As further explained by the authority, a non-invasive device to be used in contact with injured skin (including a device, the principal intention of which is to manage the microenvironment of a wound) is a Class B medical device. According to the guidance, the products covered by the scope of this rule are intended to assist healing by controlling the level of moisture and regulating the humidity, temperature, levels of oxygen, other gases, and pH values of the wound environment or by influencing the process by other physical means. The highest classification – Class C – applies to the products intended to be used in the context of wounds that have breached the dermis and where the wounds can only heal by secondary intent. These products are used in the context of healing severe wounds.
The second classification rule applies to non-invasive medical devices intended to channel or store body liquids or tissues. This category also covers the products intended to be used in the context of substances that are intended to be delved into the body. Under the general rule, such products are Class A medical devices, except for specific cases, namely:
- When connected to an active medical device – Class B;
- When intended to be used for blood, other body liquids, or to store organs – Class B;
- When intended to store blood – Class C.
The third rule describes the products intended to modify the biological or chemical composition of the blood or other liquids (including the ones intended to be delivered into the body). This category covers two types of medical devices, namely:
- A non-invasive device to modify the biological or chemical composition of blood, other body liquids, or other liquids to be infused in the patient – Class C;
- A non-invasive device to be used in treatment consisting of filtration, centrifugation, or exchange of gas or heat – Class B.
The document also provides examples of the products falling within both the aforementioned categories.
The last, fourth rule applies to all other non-invasive medical devices that are not covered by the scope of any other (specific) rules described hereabove, as well as the ones that are intended to be in contact with intact skin or not supposed to be in contact with the patient at all. According to the said rule, all such products will be Class A medical devices unless higher classification under specific rules such devices are subject to applies.
In summary, the present SAHPRA guidance describes in detail the approach to be followed when determining the class of a non-invasive medical device based on existing classification rules. The authority highlights the key points to be taken into consideration in this respect, as well as the most important factors the parties responsible for medical devices should pay attention to.
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