The new article highlights the aspects related to the classification rules to be applied with respect to invasive medical devices.
Table of Contents
The South African Health Products Regulatory Authority (SAHPRA), a country’s agency responsible for ensuring the safety and proper performance of medical devices allowed for marketing and use in the country, has published a guidance document dedicated to the classification of general and in vitro diagnostic medical devices. The document provides an overview of the existing classification rules, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance with the applicable regulatory requirements. Provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
The scope of the guidance covers, inter alia, the aspects related to the classification of invasive medical devices.
First of all, the authority provides a flowchart illustrating the approach to be applied when determining the class of an invasive medical device based on the key criteria to be considered. According to the document, the applicable classification would greatly depend on the duration of use. For the purpose of classification, the applicable rules distinguish the following categories:
- Transient use (less than 60 minutes);
- Short-term use (at least 60 mins and not more than 30 days);
- Long-term use (more than 30 days).
As a separate category, the authority distinguishes products intended to be connected to an active medical device of Class B or higher – such products should also be classified as Class B medical devices.
As further described in the guidance, additional factors to be taken into consideration when determining the class of an invasive medical device in question include, inter alia, the following:
- Whether the product is a reusable surgical instrument (then it will be a Class A medical device);
- Whether the use of the device is associated with the supply of energy or ionizing radiation (Class C applies);
- Whether the device is intended to be used in direct contact with the central nervous system or diagnose/monitor control defects of the heart/central circulatory system (then it will be a Class D product).
Devices Penetrating Body Orifices
According to the guidance, Rule 5 applies to invasive medical devices intended to be used to penetrate body orifices – as explained by the authority, this rule covers devices that enter the body through existing body orifices (for example, ear, mouth, nose, eye), and surgically created stomas; devices covered by this rule tend to be for diagnostic and therapeutic use in particular specialties.
The rule covers various invasive medical devices, including the ones intended or not intended to be used in connection with other medical devices, different in terms of duration of use and principal mode of action – the way the device achieves its intended purpose.
Surgically Invasive Devices
Another rule described in the guidance – Rule 6 – applies to surgically invasive devices intended for transient use. According to the guidance, this rule covers devices that are to be used continuously for less than 60 minutes and are used to create a conduit through the skin (needles, cannulae), surgical instruments (scalpels, saws), and various types of catheters, suckers. The aspects to be taken into consideration with respect to such devices include, inter alia, the following:
- Whether they are reusable surgical instruments (as it was mentioned before, should it be the case, Class A will apply);
- Whether they are intended to supply energy in the form of ionizing radiation (then the product will be a Class C medical device);
- Whether they are intended to have a biological effect or to be wholly or mainly absorbed;
- Whether they are intended to administer medicines;
- Whether they are intended to be used in direct contact with the central nervous system;
- Whether they are intended for transient use to diagnose, monitor, control, or correct a defect of the heart or central circulatory system through direct contact (in this or previous provision applies, such products are Class D medical devices).
Surgically Invasive Devices for Short-Term Use
The scope of the guidance also covers surgically invasive medical devices intended to be used from 60 minutes to 30 days, which is considered short-term use in the context of surgery or post-operative care. This category covers infusion devices and catheters of various types. Some of these products are intended to administer medicines or undergo a chemical change when being in the human body. These products could also have a biological effect or be absorbed (partially or in full) by the human body. In general, the factors to be considered with respect to such devices are similar to the ones that apply to other products described in the present guidance.
Long-Term Use and Implantable Products
The document also describes the approach to be applied with respect to implantable medical devices, as well as the ones intended for long-term use. In particular, the respective rule covers implants used in orthopaedic, dental, ophthalmic, and cardiovascular fields; and also soft tissue implants used in plastic surgery. In addition to the general factors applicable to other invasive medical devices, this category also covers products that could be life-supporting or life-sustaining.
In summary, the present SAHPRA guidance describes in detail the regulatory approach to be applied with respect to invasive medical devices intended to be marketed and used in the country. The document addresses the most important aspects related to various invasive devices depending on the duration of use and other factors.
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