Class A Exemption from Establishment Licensing under Position Statement 9.106

1. Key takeaways

Not every device in South Africa requires an establishment licence. Under SAHPRA Position Statement 9.106 on Class A medical devices, manufacturers, distributors and wholesalers of Class A medical devices that are non-sterile and non-measuring are exempt from the establishment licence requirement. This is a narrow exemption, and all three conditions must hold simultaneously: the device must be Class A, non-sterile and non-measuring. What is exempted is the licence, not the other obligations — vigilance, labelling, instructions for use and compliance requirements all continue to apply. The exemption is therefore best understood as a licence-scope carve-out rather than a general deregulation of low-risk products. Companies should document each of the three conditions with evidence at the point of assessment, because a decision that rests on an undocumented assumption can unravel during inspection, tender participation or a future classification review, and the operational consequences then arrive at the worst possible moment.

2. Legal basis

3. Expert insights

Insight one: the three conditions are conjunctive, and failing any one removes the exemption. Class A, non-sterile, non-measuring — all three must be satisfied together. A pack of sterile gauze (sterile) does not qualify; a thermometer with graduations (measuring function) does not qualify; a product that is both sterile and graduated certainly does not. When making the exemption determination, companies must document each condition with evidence rather than concluding from the single assertion that the product is low risk. A one-page memorandum recording the class, sterilisation status and measuring assessment, with the supporting annexes cited, costs little now and prevents expensive disputes later.

Insight two: the assessment of a measuring function has its own dedicated rules. Section 3.3 of SAHPGL-MD-04 v5 provides that where the manufacturer intends the device to have a measuring function, it is deemed to have one, and Section 3.4 gives worked examples for comparison. This means that whether a device measures depends on the intended purpose, not on technical precision — a gauge that gives only rough indications still falls within the category if it is described as measuring in the instructions for use. Marketing and regulatory wording must therefore be reconciled before the exemption decision is finalised.

Insight three: exemption from licensing is not exemption from vigilance and labelling duties. The labelling (Regulation 22), instructions for use (Regulations 23 and 24) and vigilance (Regulation 17) requirements of Notice 1515 do not presuppose holding a licence. Unlicensed companies must still establish an adverse event reporting mechanism. The most common gap in practice is precisely this: a company concludes that it needs no licence and, on that basis, builds no vigilance process at all, leaving it exposed on an obligation that was never exempted and is enforceable against any establishment operating in the market.

Insight four: the exemption affects tender eligibility. SAHPRA states expressly that participation in national and provincial tenders requires presentation of a valid SAHPRA establishment licence. Companies relying on the exemption are directly excluded from public procurement scenarios — for businesses targeting the public market, voluntarily applying for a licence is a necessary move even though the law does not force it. The licence then functions as a commercial qualification document, and its renewal timeline should be aligned with tender cycles.

Insight five: a classification change carries the exemption status with it. If a product rises to Class B because of an adjusted intended purpose, repackaging into a kit, or a change in the applicable rule, the exemption lapses and the company must apply under the licensing requirements afresh. Classification should therefore be reviewed annually as a standing exercise, not treated as a one-time conclusion, and any change in instructions, claims or pack composition should trigger an immediate reclassification check before the product continues to be supplied.

4. Practical recommendations

1. Document the exemption determination condition by condition: record written conclusions separately for class, sterilisation status and measuring function.
2. Never omit the vigilance mechanism because of the exemption: adverse event reporting obligations still apply.
3. Apply voluntarily for a licence if targeting public markets: tenders require presentation of a licence.
4. Review classification annually: classification changes carry the exemption status with them.
5. Assess kits separately: after classification at the highest class, the exemption may be lost.
6. Retain the current text of Position Statement 9.106: the basis for the exemption must be presentable on demand.

5. Verification checklist

• □ Verify that the product is classified Class A (per SAHPGL-MD-04 v5)
• □ Verify that the product is supplied non-sterile
• □ Verify that the product has no measuring function (per Section 3.3)
• □ Verify that the assessment of the three conditions is recorded in writing
• □ Verify that vigilance and labelling obligations continue to apply
• □ Verify the hard requirement of an establishment licence for public tenders
• □ Verify that an annual classification review mechanism is in place
• □ Verify that the current text of Position Statement 9.106 is retained on file

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.