Four Risk Classes: Classification from Class A to Class D

1. Key takeaways

South Africa applies a four-tier risk classification aligned with IMDRF principles: Class A (low risk), Class B (low to moderate risk), Class C (moderate to high risk) and Class D (high risk), with risk directed at patients, users or public health. The classification rules are set out in SAHPGL-MD-04, the Guideline on the Classification of Medical Devices and IVDs, of which the current version is v5, dated 27 February 2025. Non-IVD devices are governed by 16 classification rules, and IVDs by 7 rules. Where multiple rules apply simultaneously or the outcome is unclear, the higher risk class applies; classification disputes are decided by SAHPRA. Classification is not an administrative formality in South Africa: it drives the establishment licence scope, the registration expectations under any future call-up notice, and the depth of technical documentation. Getting it wrong at the start propagates through every downstream submission, so companies should treat classification as a documented engineering decision with traceable reasoning rather than a one-line form entry.

2. Legal basis

3. Expert insights

Insight one: the decisive factor in classification is the intended purpose, not the product name. The guideline makes clear that classification is based on the intended purpose assigned by the manufacturer or distributor, the level of risk to patients and users (the probability and severity of harm), the degree of invasiveness and the duration of use and exposure. The same device applied to different body sites may fall into different classes; the intended purpose can be drawn from the instructions for use, labelling, the original manufacturer’s advertising materials and technical files. This explains why identically named products can receive different classification outcomes in different companies’ hands, and why marketing language needs to be written with regulatory consequences in mind.

Insight two: the 7 IVD rules and the 16 non-IVD rules are two independent systems. The IVD rules divide by analyte and use: Rule 1 covers high-risk pathogens (Class D); Rule 2 covers blood grouping (Class C and D); Rule 3 covers Class C; Rule 4 covers self-testing (Class C); Rule 5 covers control materials (Class B); Rule 6 covers reagents and instruments (Class A); and Rule 7 is the residual rule (Class B). Companies cannot extrapolate IVD classifications from non-IVD reasoning, and this is the single most common error GRZAN sees when reviewing submission pipelines for first-time South African entrants with combined diagnostic portfolios.

Insight three: Rules 13, 14, 15 and 16 are South African additional rules that may not align internationally. The guideline specifically flags that manufacturers and distributors should pay close attention to Rules 13 to 16 (additional rules), because their application may not be consistent across jurisdictions. Practical estimate: for products touched by these rules, it is advisable to confirm classification with SAHPRA through a procedural enquiry or in writing before submission, so that the recorded class is not challenged at review when timelines matter most.

Insight four: combinations, systems and procedure packs take the highest class. Where a device is intended for use with other devices, the classification rules must be applied to each device individually; for device groups, systems or procedure packs, the overall classification is the highest classification of any single device in the combination. The inclusion of a registered medicine in a procedure pack does not affect the classification. This rule directly determines how finely a product list must be built: a pack containing one Class C device is managed as Class C as a whole, and under-specifying the pack contents invites rework at review.

Insight five: software is treated as an active device, but accessories are classified separately. The guideline states that software meeting the device definition also qualifies as an active medical device (because its operation depends on an energy source); software intended to drive, control or influence the functioning of a device generally falls in the same class as that device; software that is an accessory to a device is classified separately; and software not necessary for the device to operate is treated as an accessory. AI and ML software is classified within this same framework (see also MD08-2025/2026), so algorithmic products should not assume a special pathway.

4. Practical recommendations

1. Fix the intended purpose before applying the rules: extract it from the instructions for use and labelling, not from the product name.
2. Use the 7 rules for IVDs and the 16 rules for non-IVDs: the two systems must never be mixed.
3. Where in doubt, take the higher class: this is an explicit regulatory rule and also the safest choice.
4. Manage combinations at the highest class: annotate this when building the product list.
5. Confirm Rule 13 to 16 products early: consult SAHPRA in writing where necessary.
6. Record the outcome in GLF-MD-14A: the classification matrix is the common baseline for later submissions and inspections.

5. Verification checklist

• □ Verify the four-tier class definitions against Regulation 11(1)
• □ Verify that the current text of SAHPGL-MD-04 v5 (2025-02-27) has been obtained
• □ Verify whether the product is an IVD (7 rules) or a non-IVD (16 rules)
• □ Verify that the intended purpose has been extracted and locked from the instructions for use and labelling
• □ Verify that each applicable rule has been assessed and the higher class taken where unclear
• □ Verify that the applicability of Rules 13 to 16 has been assessed separately
• □ Verify that combinations, systems and procedure packs are classified at the highest class
• □ Verify that the classification outcome has been recorded in the GLF-MD-14A matrix

Regulatory information verified as of 29 October 2026. The instruments, guidelines and effective dates described in this article are limited to the content published by the official sources listed under the legal basis above as at that date; where official documents are updated, the latest published version prevails.

• South Africa local support: GRZAN assists manufacturers in the Chinese mainland and abroad with SAHPRA Medical Device Establishment Licence (MDEL) applications and product registration preparation, including Authorised Representative (AR) arrangements, ISO 13485 certification pathway planning and CAB selection, GMDN coding and classification decisions, technical documentation, and the setup of vigilance and adverse event reporting mechanisms.
• Service capabilities: product attribute determination and risk classification (Class A, B, C, D), establishment licence applications and renewals, reliance pathway arguments, technical documentation and essential principles conformity arguments, labelling and instructions for use localisation in English, and post-market vigilance and annual compliance submissions.
• Contact: info@grzanglobal.com; hito.lin@grzan.cn; website www.grzan.cn.