The document highlights the key points related to the current classification rules for different types of medical devices.
Table of Contents
The South African Health Products Regulatory Authority (SAHPRA), the country’s national regulator agency, has published a guidance document dedicated to the classification of medical devices, including both general and in vitro diagnostic ones. The document provides an overview of the classification rules set forth under the existing regulatory framework, as well as additional recommendations and clarifications to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, it is important to mention that provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes thereto, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations. Furthermore, the authority states that the approach described in the document is not exhaustive, so a case-by-case assessment could be required. Should it be reasonably necessary to assess a specific case, the authority will be entitled to request additional documentation or information to be provided by the manufacturer or another party responsible for a medical device in question.
While the overall goal of the authority is to ensure the safety and proper quality of all the devices allowed to be marketed and used in the country, it encourages the parties applying for marketing approval to comply with any and all applicable regulatory requirements and follow the appropriate procedures to facilitate and streamline the appropriate processes.
The initial version of the guidelines described herein has been published by the authority earlier in August 2016.
Regulatory Background
First of all, the authority mentions that the country’s existing regulatory framework is established by the Medicines and Related Substances Control Act No. 101 of 1965 together with the respective Regulations and Guidelines associated thereto, accessible online via the authority’s website.
According to the document, the aim of this guidance is to assist manufacturers, importers, distributors, and wholesalers of medical devices and IVDs in the classification of medical devices and IVDs required for the licensing of manufacturers, distributors, and wholesalers and registration of medical devices or IVDs. The scope of the guidance covers any and all products regulated as medical devices.
The authority explicitly states that deviations from the approach described in the guidance could be allowed, provided such deviations are based on scientific developers and are duly justified with the appropriate justification to be included in the submission. Furthermore, in case of any concerns, applicants are encouraged to request additional consultation with respect to the forms and documents to be submitted. The authority additionally emphasizes the importance of referring to the current version of classification rules.
As it was mentioned before, the purpose of this guidance is to assist manufacturers, importers, distributors and wholesalers of medical devices and IVDs in identifying the classes of the products which they manufacture, import, export, and distribute in accordance with Act 101 of 1965.
Medical Device Classification: Overview
According to the guidance, the current regulatory framework establishes two separate sets of classification rules to be used for general and in vitro diagnostic medical devices respectively. In particular, any and all medical devices allowed to be marketed and used in the country are divided into the following classes based on the risks associated thereto:
- Class A – Low risk;
- Class B – Low-moderate risk;
- Class C – Moderate – high risk;
- Class D – High risk.
For the purpose of classification rules, the risk to be considered relates to the patient to public health.
The authority also explains that sometimes identical medical devices could be classified differently due to them being initially intended to be used in different parts of the body. Consequently, it is vitally important to ensure the intended use of the product is properly specified by the manufacturer so that the appropriate classification could be determined. Indication of the intended use of the device could be reflected in the instructions for use (IFU), label used, advertising materials created by the manufacturer, or relevant technical documentation accompanying the device.
It is also important to mention that classification rules applied in South Africa could be different from the ones applied in other countries. Should the device be intended to be supplied in South Africa, the country’s rules should be followed and should prevail in case of any discrepancies.
Principles
The document further describes in detail specific principles to be followed when applying the existing classification rules in order to ensure proper classification of a medical device in question. In particular, the authority states that the classification rules are outlined in technical rules for medical devices and technical rules for IVDs; the classification process is based on the manufacturer’s intended purpose, taking into account the design and how the medical device or IVD works. The authority also mentions that sometimes more than one rule applies – in such cases, a higher classification should be followed.
When determining the applicable classification of a medical device in question, all the classification rules should be considered. It is also stated that in case the device subject to review is initially intended to be used in combination with another device, these products should be assessed separately. The same approach applies with respect to accessories to medical devices.
In the case of a medical device group, system, or procedure pack, the overall classification should be based on the highest classification of any individual device, while any medicines present should not be considered.
Software-related Rules
The authority pays additional attention to the way classification rules should be applied with respect to the software. In particular, the document states the following:
- If the software meets the definition of a medical device, it should be considered an active medical device since an electricity supply is necessary for its operations;
- If the software is initially intended to operate a medical device or influence the way the latter operates, or controls it, the applicable classification should be the same as for the said device;
- If the software is an accessory to a medical device, it should be assessed and classified separately (the software will be considered an accessory in the case when it is not essential for the medical device to operate).
In summary, the present guidance provides a brief overview of the applicable classification principles and outlines the key points associated thereto. The document also explains the way classification rules should be applied in certain specific cases.
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