Offences, Penalties and Investigation Powers under Notice 1515

1. Key takeaways

Liability for medical device offences in South Africa is set out in Notice 1515 Regulation 19 (Offences and penalties), which is placed next to Regulation 18 (Investigation) — Regulation 18 gives SAHPRA the powers of investigation and sampling, while Regulation 19 defines the consequences of offences. In addition, the parent statute, the Medicines and Related Substances Act (Act No. 101 of 1965), contains its own framework of statutory liability in the field of medicines and related substances. For companies, the most realistic risk is not the fine itself but the knock-on effect of an offence record on the survival of the establishment licence, on tender eligibility and on import clearance. A single compliance failure can therefore ripple far beyond the administrative penalty, shaping the company’s ability to operate and to sell in the South African market for years afterwards.

2. Legal basis

3. Expert insights

Insight one: Regulations 18 and 19 together form a complete detection-and-enforcement chain. Regulation 18 governs the investigation and, during an investigation, the methods of taking samples, the certificate to be issued and the report of analysis results; Regulation 19 follows immediately with offences and penalties. This sequencing shows that the South African enforcement path is to sample and secure evidence first, then characterise the conduct and pursue liability. Every action a company takes while cooperating with an investigation — every document handed over, every sample released — will be recorded and may later be relied upon.

Insight two: Regulation 20 on compliance with requirements is a standalone provision, showing that offences are not limited to the sale stage. In the table of contents of the 2016 Regulations, Regulation 20 is titled Compliance with requirements. This means the range of offence conduct extends across labelling, instructions for use, advertising, records, vigilance and import activities, rather than being confined to unlicensed operation. A company can commit an offence without ever selling an unlicensed device, purely through lapses in documentation or reporting.

Insight three: operating without a licence is the most fundamental category of offence. SAHPRA states expressly that without a valid establishment licence, no medical device may be manufactured, distributed, imported, exported or sold. The consequence of this category of offence is that the conduct itself is invalid — affected products may have to be withdrawn from the market, recalled or destroyed, and transactions concluded during that period carry legal defects that customers and distributors will not easily forgive.

Insight four: the knock-on consequences of an offence record often exceed the direct penalty. Beyond the penalty itself, licence renewals, variation applications, tender eligibility and import clearance are all negatively affected. For companies targeting the public procurement market, a single offence record can mean years without the ability to bid — that, rather than the fine, is the true cost of non-compliance.

Insight five: advertising and exhibitions are also within the regulatory scope. The 2016 Regulations contain Regulation 21 (Advertising of medical device or IVD) and, in the 2021 draft, provisions on exhibitions or evaluation. Promotional activity directed at the South African market must comply with the advertising rules, and the online marketing channels commonly used by companies are equally bound by them.

4. Practical recommendations

1. Treat holding a valid establishment licence as the absolute precondition of doing business: no activities at all without one.
2. Manage compliance across all stages together: labelling, instructions for use, advertising, records, vigilance and import.
3. Standardise sampling and document-production procedures when cooperating with investigations: every action is recorded.
4. Assess the knock-on effects of an offence record on tenders and customs clearance.
5. Pre-clear advertising and online promotional content against Regulation 21.
6. Consult a South African admitted attorney on questions of liability characterisation: this article is not legal advice.

5. Verification checklist

• □ Regulation 19 has been confirmed as the provision governing offences and penalties
• □ Regulation 18 has been confirmed as vesting investigation and sampling powers in SAHPRA
• □ The compliance requirements of Regulation 20 have been confirmed as covering all stages
• □ All business activities are premised on a valid establishment licence
• □ Labelling, instructions for use, advertising, records, vigilance and import are covered by the compliance programme
• □ Sampling and document-production procedures for investigations have been standardised
• □ Advertising and online promotional content has been pre-cleared against Regulation 21
• □ Questions of liability characterisation have been referred to a South African admitted attorney

Regulatory information verified as of 29 October 2026. The regulations, guidance and effective dates described in this article are limited to the official sources listed in the legal basis section above as published on that date; where official documents have been updated, the most recently published version prevails.

• Local resources in South Africa: GRZAN assists manufacturers from the Chinese mainland and other markets with SAHPRA medical device establishment licence (MDEL) applications and product registration preparation, including authorised representative (AR) scheme design, ISO 13485 certification pathway planning and CAB selection, GMDN coding and classification determination, technical documentation, and the setup of vigilance and adverse event notification mechanisms.
• Service capabilities: product attribute determination and risk classification (Class A, B, C, D), establishment licence applications and renewals, reliance pathway argumentation, technical documentation and essential principles conformity argumentation, labelling and instructions for use localisation in English, and support for post-market vigilance and annual compliance submissions.
• Contact: info@grzanglobal.com; hito.lin@grzan.cn; website www.grzan.cn.