The South African Health Products Regulatory Authority (SAHPRA) has released an updated "Guideline for the Classification of Medical Devices and In Vitro Diagnostic (IVD) Devices". This guideline, effective 27 February 2025, provides a structured classification system for medical devices and IVDs based on risk assessment and intended use. It aligns with the Medicines and Related Substances Act, 1965 (Act 101 of 1965) and serves as a regulatory reference for manufacturers, distributors, and importers.
The Purpose of the guideline is to assist manufacturers, importers, distributors, and wholesalers in classifying medical devices (including non-IVDs and IVDs) for licensing and registration purposes in accordance with the Medicines and Related Substances Act No. 101 of 1965 in South Africa.
The guideline outlines the classification system used in South Africa for medical devices and IVDs, based on the medical device regulations of Act 101 of 1965.
The manufacturer or distributor is responsible for determining the classification of a medical device based on:
Intended use of the device
Level of risk to patients, users, and other persons
Degree of invasiveness
Duration of use and exposure
Classification System for Medical Devices
Medical devices are classified into four risk-based categories:
Class | Risk Level | Examples |
Class A | Low risk | Bandages, surgical gloves |
Class B | Low to moderate risk | Dental implants, infusion pumps |
Class C | Moderate to high risk | Blood transfusion sets, diagnostic ultrasound |
Class D | High risk | Pacemakers, heart valves, life-support devices |
Classification of IVDs
IVDs are categorized based on public health and personal risk:
Class | Risk Level | Examples |
Class A | No public health risk | General lab equipment, specimen containers |
Class B | Low public health risk | Pregnancy tests, cholesterol tests |
Class C | Moderate public health risk | HIV self-tests, genetic screening tests |
Class D | High public health risk | Blood donor screening tests for HIV, Hepatitis B/C |
The guidance also includes detailed sections on:
Principles for applying classification rules
Classification of non-IVD medical devices (including rules based on invasiveness, duration of use, and whether the device is active)
Additional classification rules
Classification of IVD medical devices (including rules and rationale)
The SAHPRA classification system ensures that medical devices and IVDs meet strict safety and quality requirements, protecting both patients and healthcare providers. 🔗 For full classification rules, visit: SAHPRA Guideline for Medical Device Classification
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