© 2025 社團法人國家生技醫療產業策進會 & 財團法人生技醫療科技政策研究中心 版權所有
2025-11-04
Over 70% of diagnoses in Africa rely on in-vitro diagnostics (IVD). This year, the 9th Healthcare+ Expo Taiwan has invited Sarah Cohen, Executive Officer of the Southern African Laboratory Diagnostics Association (SALDA)—the most important IVD industry organization in Africa—to visit Taiwan. With its extensive network and strong influence across the African continent, SALDA serves as a crucial gateway for Taiwanese companies seeking to expand into the South African market. During her visit, Cohen aims to find Taiwanese partners capable of collaborating with SALDA to establish an IVD supply chain in South Africa and across Africa.
The 9th Healthcare Expo Taiwan will be held at Taipei Nangang Exhibition Center, Hall 1 from December 4th to 7th, expecting nearly 40 overseas industry associations to visit Taiwan in search of collaboration opportunities with Taiwan’s medical and biotechnology sectors. Ahead of the event, the organizers have launched a special “International Associations Interview Series,” featuring first-time visiting representatives who share their perspectives on Taiwan’s market potential and cooperation opportunities, helping domestic companies prepare for early business matchmaking.
This interview features the SALDA, founded 24 years ago and composed of South African IVD industry players. Its members include manufacturers and suppliers of instruments, reagents, and diagnostic systems, with influence extending throughout Africa.
Over 60 Member Companies with a Pan-African Network in Healthcare
Cohen explained that SALDA currently has about 60 member companies, with partnerships that span South Africa and other African countries. Its network includes public and private healthcare sectors, regulatory authorities such as SAHPRA (South African Health Products Regulatory Authority), hospitals, laboratories, and patient organizations. The association is dedicated to ensuring the quality, safety, and accessibility of imported IVD products.
She noted that over 70% of diagnostic tests in Africa rely on IVD, leading to high demand for rapid, affordable, and easy-to-use testing products. Beyond promoting innovations such as point-of-care (POC) diagnostics, molecular diagnostics, and self-testing, SALDA also safeguards product quality to prevent the entry of substandard or counterfeit items. It further provides regulatory and technical consultation to assist companies in successfully importing their products.
Exploring Opportunities in Taiwan: Seeking High-Quality and Scalable Partners
Cohen described her Taiwan visit as an exploratory trip, aimed at learning more about Taiwan’s medical device industry and identifying high-quality, cost-effective, and scalable IVD suppliers. She is particularly interested in products suitable for licensing or technology transfer, such as rapid tests, POC diagnostics, and digital health platforms, with the goal of introducing them to South Africa and other African markets.
Currently, South Africa is prioritizing the registration of Class C and D IVD products related to HIV, malaria, and tuberculosis. Cohen hopes to use this Expo to exchange views with Taiwanese experts on rapid test products that could be prioritized for introduction to help prevent the spread of major infectious diseases.
Seeking Taiwanese Partners with R&D and Mass Production Capabilities
Cohen emphasized that SALDA is particularly focused on affordable, scalable diagnostic products and high-quality rapid test kits. It also welcomes digital solutions involving AI-based image analysis and smart laboratory automation. Given South Africa’s vast geography, remote testing and portable diagnostic devices hold significant potential.
She stressed that now is an ideal time for Taiwanese companies to enter the South African market. The South African government is actively promoting local manufacturing and supply chain resilience, while Taiwanese firms possess valuable experience producing internationally certified products with competitive manufacturing efficiency. SALDA’s members are especially open to collaboration through joint ventures, technology exchange, or talent training programs.
Products certified by CE, FDA, or WHO prequalification and companies willing to support local production and supply chain establishment will be regarded as ideal partners.
Strong Market Demand and Improving Regulatory Framework in South Africa
Cohen noted that demand for IVDs in South Africa is rapidly increasing, covering both non-communicable diseases (such as hypertension and diabetes) and infectious diseases (such as RSV, STDs, and tuberculosis). Moreover, ongoing R&D is needed for emergency response to outbreaks like Ebola and monkeypox.
She reminded that foreign companies entering South Africa must prepare import and regulatory documentation, including manufacturer and distributor licenses and ISO 13485 certification, and must comply with post-market surveillance regulations. Collaborating with local partners can often accelerate importation and approval processes. SALDA can also assist companies in liaising with regulatory authorities to ensure smooth product entry into the market.