2025 Recap: Innovation, AI And Evolving Compliance In The Medical Device Landscape

Medical devices are a crucial component in the life sciences industry, with ongoing research and innovation in the medical device field driving new solutions to enhance accessibility and quality of healthcare. The South African Health Products Regulatory Authority ("SAHPRA") has published notable communications in 2025 regarding the evolving regulatory landscape for medical devices in South Africa. Furthermore, as artificial intelligence ("AI") becomes increasingly prevalent and more widely accepted, SAHPRA has acknowledged its rapid advancement and transformative potential and is now actively addressing how best to regulate the use of AI. These developments are particularly beneficial for the healthcare sector, where insufficient regulation or guidance could have a direct impact on accessibility and quality of healthcare.

Manufacturers, distributors and wholesalers of medical devices are required to be licensed with SAHPRA in terms of section 22C(1)(b) of the Medicines and Related Substance Act 101 of 1995 ("Medicines Act"). SAHPRA is mandated, in the public interest, to monitor, evaluate, regulate, investigate, inspect, register and control medical devices, in vitro diagnostics ("IVDs") and related matters.

Registration of medical devices: Section 14 of the Medicines Act prohibits the sale of medical devices that have not been registered if SAHPRA has issued a declaration requiring registration for those medical devices or classes thereof ("Call-Up Notice"). As at November 2025, SAHPRA has not yet issued any Call-Up Notices for medical device registration under the Medicines Act. However, there have been signs of progress towards preparing and planning for the registration of medical devices. In May 2024, the Medical Devices Unit, SAHPRA's medical device registration subunit, invited interested parties to submit an Expression of Interest ("EOI") to participate voluntarily in a medical device registration feasibility study ("Medical Device Registration Feasibility Study"). The Medical Device Registration Feasibility Study aims to validate the proposed process for medical device registration. In October 2025, SAHPRA reported that the Medical Device Registration Feasibility Study is ongoing with 15 applicants voluntarily participating in the project. Although 32 products were targeted for the Medical Device Registration Feasibility Study, only 22 products have been received from the participants. In Quarter 4 of the 2024/2025 FY, SAHPRA has reported that 18 product applications were received from 12 applicants, in which the products are categorised under the product risk classification Class C (moderate-high risk) and Class D (high risk) IVDs and non-IVD products for Human Immunodeficiency Virus (HIV) and Tuberculosis (TB). SAHPRA expects to finalise and publish the preliminary report on the Medical Device Registration Feasibility Study in the 2025/26 FY. The Medical Device Registration Feasibility Study is a critical preliminary step before the publication of a Call-Up Notice for a pilot Class D update.

ISO 13485 Communication: SAHPRA published the 'ISO 13485 Certificate as a prerequisite for the approval of a Medical Device Establishment Licence' (18 September 2025) ("ISO 13485 Certificate Communication"). The ISO 13485 Certificate Communication provides that effective from 1 June 2025, manufacturers and distributors (importers) of medical devices and IVDs who hold a medical device establishment licence under section 22C(1)(b) of the Medicines Act and are due for renewal, must comply with regulatory requirements and possess valid documentary proof of certification to the international standard ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for regulatory purposes ("ISO 13485 certificate"), or its latest version. Accordingly, upon renewal, manufacturers and distributors (importers) of medical devices and IVDs will be required to provide a valid ISO 13485 certificate issued in the name of the South African licensed medical device establishment, at the same address, and from a SAHPRA-recognised conformity assessment body ("CAB"). If manufacturers and distributors (importers) are currently in the process of obtaining ISO 13485 certification, they must provide documentary proof of such an agreement from a CAB. Once the ISO 13485 certificate is acquired, it must be submitted to SAHPRA for verification.The ISO 13485 Certificate Communication outlines SAHPRA's phased approach to ensure that by April 2028, all manufacturers, distributors (importers), and applicants for new medical device establishment licences comply with and are certified to ISO 13485 standards. ISO 13485 is a globally recognised quality management system (QMS). It addresses minimum regulatory requirements for medical devices and IVDs by outlining requirements for manufacturers and suppliers. ISO 13485 establishes a minimum quality assurance framework to ensure medical devices and IVDs are appropriately managed, are safe, and perform as intended by the manufacturer.

AI/ML Communication: While formal product registration for medical devices has not yet begun under the existing regulatory framework, SAHPRA is proactively engaging with industry stakeholders to ensure patient safety, compliance and responsible innovation. To this end, SAHPRA has published the 'Regulatory Requirements for Artificial Intelligence and Machine Learning (AI/ML) -enabled medical devices' (26 September 2025) ("AI/ML Communication"). The AI/ML Communication provides industry stakeholders with a comprehensive overview of the current and emerging regulatory framework for AI and machine learning ("ML") -enabled medical devices, including IVDs, within the South African context and aligns with SAHPRA's 2025–2030 Strategic Plan, which prioritises developing clear guidelines and updated legislation for AI-based health technologies and seeks to harmonise South African requirements with international best practices.

The AI/ML Communication confirms that an AI/ML-enabled medical device is defined as a product that meets the definition of a 'medical device' as defined in the Medicines Act and uses one or more AI or ML algorithms to fully or partially perform its intended medical purpose. This includes, but is not limited to, AI/ML applications in:

• medical imaging analysis (e.g. software using AI to detect tumours or fractures in radiological images);
• predictive algorithms (e.g. an ML model that forecasts the risk of patient deterioration);
• clinical decision support systems (e.g. AI-driven diagnostic aids or treatment recommendation systems for healthcare professionals); and
• wearable health monitoring technologies (e.g. wearables that pick up biosignals and alert to abnormalities).

SAHPRA expects adherence to internationally recognised best practices and responsible use of AI, which includes: patient safety and risk management, transparency and explainability, cybersecurity, data integrity, and privacy, performance monitoring and adaptability and clinical evaluation. From a regulatory compliance perspective, all AI/ML medical devices are required to comply with the current regulatory framework as outlined below:

• Regulatory authorisation and Licensing: Any person or company intending to import, manufacture, or market an AI/ML-embedded medical device must possess a medical device establishment licence issued under section 22C(1)(b) of the Medicines Act.
• Risk classification: Medical devices are classified according to a four-tier risk system (Classes A–D), with higher-risk devices (Classes C and D) subject to greater scrutiny. SAHPRA is responsible for the final classification of the risk class.
• ISO 13485 compliance: Evidence of compliance with ISO 13485 and relevant software lifecycle standards is required.
• Evidence of safety and performance: The manufacturer must be prepared to submit documentation, typically including a technical file and clinical evidence, demonstrating the medical device's safety, performance, and effectiveness for its intended use. For higher-risk medical devices, SAHPRA requires evidence of prior approval from a trusted jurisdiction or body.
• Post-market surveillance: Manufacturers must implement robust post-market monitoring, including continuous performance assessment and incident reporting in accordance with SAHPRA guidelines.

SAHPRA has also noted emerging issues with the adoption of AI/ML-enabled medical devices as follows:

• Change control: Managing software changes and algorithm updates poses a challenge for AI/ML medical devices. Significant changes to a medical device already on the market (especially those expanding usage or altering core logic) must be communicated to SAHPRA. Major updates may require regulatory review. SAHPRA is monitoring international developments regarding Predetermined Change Control Plans (PCCPs) for adaptive AI algorithms, but until formal guidance is issued, all significant changes require notification.
• Generative AI-enabled devices: Medical devices utilising generative AI (e.g. large language models) present unique regulatory challenges, such as broad intended use, inconsistent outputs, opaque training data, and validation difficulties. These medical devices will be classified according to risk and standard regulatory processes will apply. Developers unable to meet standard requirements should proactively seek guidance from SAHPRA.

The AI/ML Communication underscores SAHPRA's commitment to balancing innovation in AI/ML with patient safety and ethical standards. Importers and manufacturers are responsible for initially determining if their products qualify as medical devices and for ensuring accurate characterisation and risk classification. Early consultation with SAHPRA is recommended in cases of uncertainty.

Further guidance and updates are anticipated as SAHPRA continues to refine its regulatory approach to AI/ML-enabled medical devices. Stakeholders are encouraged to remain engaged with SAHPRA to ensure compliance and to support the safe integration of these technologies into South Africa's healthcare system.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.