The article outlines the key points associated with the classification rules for medical devices.
Table of content
The South African Health Products Regulatory Authority (SAHPRA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the classification of medical devices, including the in vitro diagnostic ones. The document provides an overview of the applicable regulatory requirements, 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 thereto.
Introduction
The SAHPRA provides this guideline to assist manufacturers, importers, distributors, and wholesalers in classifying medical devices and in vitro diagnostic (IVD) devices. The classification rules ensure that devices meet the required safety, quality, and performance standards in compliance with the Medicines and Related Substances Act, 1965 (Act 101 of 1965).
According to the document, medical devices and IVDs are classified based on risk levels associated with their intended use. The guideline reflects the latest regulatory thinking and aligns with international best practices for medical device regulation. The document also provides a structured approach to licensing manufacturers and registering medical devices and IVDs.
Key objectives of the guideline are to:
- outline classification rules for medical devices and IVDs.
- clarify how devices should be assessed for risk.
- ensure regulatory compliance and patient safety.
- guide stakeholders on licensing and registration procedures.
Furthermore, the authority explicitly states that medical device manufacturers must consult the latest version of the guideline before submitting their applications to avoid regulatory delays.
Legal Provisions
The classification of medical devices and IVDs falls under the authority of SAHPRA and aligns with the General Regulations of the Medicines and Related Substances Act, 1965. Compliance with these regulations is essential for obtaining approval to manufacture, distribute, or sell medical devices in South Africa.
Manufacturers must ensure that their products comply with both local and international standards, including sterility assurance levels and quality control measures. The guideline could be subject to further updates to reflect ongoing changes in medical technology and regulatory requirements.
Classification of Medical Devices (Non-IVDs)
Medical devices are categorized based on their level of risk and intended use. The classification framework consists of four classes:
- Class A – Low risk;
- Class B – Low–moderate risk;
- Class C – Moderate–high risk; and
- Class D – High risk.
As further explained by the authority, the key factors for classification include, inter alia, the following ones:
- Intended Use: The purpose for which the device is designed.
- Level of Risk: The probability of harm and its severity.
- Invasiveness: Whether the device penetrates the body.
- Duration of Use: Whether the device is transient (less than 60 minutes), short-term (up to 30 days), or long-term (more than 30 days).
- Measuring Function: Whether the device is used for quantitative measurements.
- Sterility Requirements: Devices that require sterilization are subject to additional regulatory controls.
It is also mentioned that identical devices may be classified differently based on variations in intended use or risk profile.
Application of Classification Rules
Medical devices are classified into several categories based on their function and level of invasiveness.
Non-Invasive Medical Devices:
- Devices that only come into contact with intact skin.
- Devices that store or channel body fluids.
- Devices that modify biological or chemical compositions before delivery into the body.
- Examples: Bandages, syringes, and urine collection bottles.
Invasive Medical Devices – the devices that penetrate the body through natural orifices or surgically created pathways. Examples of such products would generally include endoscopes, catheters, stents, and surgical implants.
Active Medical Devices – the devices that rely on an external energy source for operation. Examples are MRI machines, ventilators, pacemakers, and infusion pumps.
Additional Classification Considerations:
- Devices incorporating medicines (e.g., drug-eluting stents) are automatically classified as Class D.
- Devices containing animal or human tissues must be assessed based on their viability and level of risk.
- Devices used for sterilization or disinfection of other medical devices are subject to specialized rules.
Classification of In Vitro Diagnostic (IVD) Medical Devices
In accordance with the applicable regulatory requirements, IVDs are classified according to their potential risk to public health and individuals:
- Class A – No public health risk or low personal risk;
- Class B – Low public health risk or moderate personal risk;
- Class C – Moderate public health risk or high personal risk;
- Class D – High public health risk.
Key classification rules for IVDs include the following ones:
- Rule 1: Detecting transmissible agents posing a high public health risk (Class D).
- Rule 2: Detecting blood group antigens and antibodies (Class C or D).
- Rule 3: Detecting transmissible agents of moderate public health risk (Class C).
- Rule 4: IVD devices for self-testing (Class C, with exceptions for non-serious conditions).
- Rule 5: Non-assay specific quality control materials (Class B).
- Rule 6: Reagents, instruments, and specimen receptacles (Class A).
- Rule 7: Other IVDs not covered in previous rules (Class B).
Compliance and Regulatory Requirements
The authority additionally reminds that in order to comply with the relevant regulatory requirements medical device manufacturers and distributors must adhere to the classification rules and provide supporting documentation, including:
- Evidence of compliance with Essential Principles.
- Documentation of risk assessment procedures.
- Technical specifications, labeling, and instructions for use.
- Justifications for any deviations from standard classification rules.
In case of disputes regarding classification, SAHPRA has the final authority to determine the appropriate category for a medical device or IVD.
References and Validity
The guideline incorporates standards such as:
- ISO 11135: Ethylene oxide sterilization requirements.
- ISO 17665: Moist heat sterilization.
- ISO 13408: Aseptic processing of healthcare products.
- ISO 14937: Characterization of sterilizing agents.
Furthermore, medical device manufacturers should regularly check for guideline updates to ensure compliance with the latest regulatory requirements.
Conclusion
In summary, the present SAHPRA guideline provides a structured approach to classifying medical devices and IVDs, ensuring compliance with safety and performance standards. Manufacturers and distributors must carefully apply the classification rules and consult SAHPRA when necessary to meet regulatory expectations and protect public health.
How Can RegDesk Help?
RegDesk is an AI-powered Regulatory Information Management System that provides medical device companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Global expansion has never been this simple.
