MedTech in Africa

Market Potential

South Africa is one of the largest medical device markets in the Middle East and Africa region and was estimated at R21 billion in 2021 and projected to grow to R29,6 billion by 2025. (Fitch Solutions, 2021).

Public Sector
Government is the major purchaser of healthcare equipment and supplies in South Africa, associated with a public healthcare sector comprising 7,901 facilities with 85,362 registered beds (Who Owns Whom, 2019).

Private Sector
This sector comprises 524 facilities with 40,514 beds. Medical device manufacturers are not currently involved in price negotiations between medical schemes and hospitals groups. Hospitals in this sector are dominated by the big four hospital groups – Netcare Limited, Life Healthcare Group, Mediclinic Southern Africa, and the National Hospital Network.

0.3% Percentage of Global Market

Reference: The Medical Devices Landscape in South Africa. Report of a survey conducted by the South African Medical Research Council, January 2022.

Local Manufacturing Opportunity

South Africa’s current manufacturing output of medical devices is small (US$200 million to US$300 million), of which more than half is exported. This output is dominated by low-tech and low-value devices in the other medical devices and consumables product areas, with some hi-tech products for diagnostic imaging.

9.1%

SA Manufacture grew to US$211 million from 2017 to 2018, to account for about 13.5% of the total market value (Who Owns Whom, 2019).

Local manufacture was expected to grow by to US$227.8 million in 2019 (Who Owns Whom, 2019).

>50%

Medical Device Export Market

Exports are mainly to other countries in Sub-Saharan Africa.

Reference: The Medical Devices Landscape in South Africa. Report of a survey conducted by the South African Medical Research Council, January 2022.

South African Healthcare

Saddled with a triple disease burden

Communicable (HIV/AIDS, TB);
Rising non-communicable (diabetes, cardiovascular disease, hypertension, cancer); and
Trauma (interpersonal violence, such as gunshot – and stab wounds).

More advanced, high-tech products and elective procedures are more commonly found in the private sector.

Reference: https://www.trade.gov/country-commercial-guides/south-africa-healthcare-medical-devices-and-pharmaceuticals (Accessed 24/08/23)

85%

Public Sector

15%

Private Sector

Healthcare Funding in South Africa

The total market size projected for 2023 is US$1,118 billion.

Reference: https://www.trade.gov/country-commercial-guides/south-africa-healthcare-medical-devices-and-pharmaceuticals (Accessed 24/08/23)

48%

of total healthcare expenditure with funding from the state (approximately nine percent of GDP). The public sector is the biggest purchaser of healthcare equipment and supplies, particularly for primary healthcare.

MEDICAL SCHEMES

are in play in South Africa, 20 of which are open and the rest restricted.

Is there an Appetite for MedTech?

Sub-Saharan Africa

– remains the least attractive region in the world in which to commercialise a medical device based on their Medical Devices Risk/Reward Index (RRI).

Despite having a population of over 300 million, the region has the smallest market in a global context, with low per capita spend, a small elderly population and low urbanisation, with the majority of the population living in poverty.

Reference: The Medical Devices Landscape in South Africa. Report of a survey conducted by the South African Medical Research Council, January 2022.

South Africa

– is the most attractive country, with a large market, the lowest risks in SSA, a relatively strong domestic economy that is business-friendly, good healthcare access, higher levels of urbanisation which facilitate access to healthcare and an improving regulatory framework.

Reference: The Medical Devices Landscape in South Africa. Report of a survey conducted by the South African Medical Research Council, January 2022.

MedTech Regulatory Framework

South Africa

The Medicines and Related Substances Amendment Act 14 (2015) introduced a four-tier, risk-based licensing and registration system, which applies to South Africa-based companies that manufacture, sell, import, export, distribute and wholesale medical devices in the country. The Act also regulates procedures for device registration and requirements relating to advertising and labelling, and the restriction of sampling for the sale of medical devices.

Reference: The Medical Devices Landscape in South Africa. Report of a survey conducted by the South African Medical Research Council, January 2022.

MedTech Regulatory Framework

South Africa

On 21 May 2021 the proposed “Regulations Relating to Medical Devices” were published in the Government Gazette for comments by interested persons (SAHPRA, 2021c).

The proposed regulations include provisions for the supply of medical devices, the registration of medical devices, licensing of establishments to manufacture, distribute or wholesale medical devices, management of medical devices and investigations, offences and penalties related to the regulations.

Reference: The Medical Devices Landscape in South Africa. Report of a survey conducted by the South African Medical Research Council, January 2022.

MedTech Regulatory Framework

South Africa

No medical device may be manufactured, distributed, imported, exported or sold without a valid SAHPRA medical device establishment license.

This is especially important for eligibility to bid for National and Provincial tenders. An exemption has been introduced for manufacturers, distributors and wholesalers of non-sterile, non-measuring Class A medical devices (SAHPRA, 2021b).

Reference: The Medical Devices Landscape in South Africa. Report of a survey conducted by the South African Medical Research Council, January 2022.

MedTech Regulatory Framework

South Africa

As part of the application for a SAHPRA medical device establishment license, a company must appoint an Authorised Representative based in South Africa who is responsible for adherence to the law, regulations and guidelines, and must list all the medical devices that it manufactures, distributes or wholesales.

The application must also include a declaration on the quality management system in place in the company, which, upon renewal of the SAHPRA license, must include ISO 13485:2016 certification (SAHPRA, 2021b).

Reference: The Medical Devices Landscape in South Africa. Report of a survey conducted by the South African Medical Research Council, January 2022.

MedTech Regulatory Framework

South Africa

Aside from statutory regulation of medical devices, in 2011, the South African Medical Technology Industry Association (SAMED) became a member of the Marketing Code Authority (MCA), making it a signatory to a single Code of Marketing Practice, adopted by various health product associations in South Africa (Who Owns Whom, 2019). (Kiara MedTech is a member of SAMED).

The Medical Device Code of Ethical Marketing and Business Practice was published in 2018. The intention is to facilitate ethical behaviour in the industry. Healthcare practitioners, customers and patients may lodge a complaint with the MCA regarding marketing and advertising of healthcare products.

Reference: The Medical Devices Landscape in South Africa. Report of a survey conducted by the South African Medical Research Council, January 2022.