3. Prostheses

According to the most recent estimates, there are currently over 600 various types of prostheses and orthoses manufacturing, assembly and fitting institutions in China [37]. In 2023, China’s prostheses sales market size in China is RMB787 million (~US$110 mn), with an annual production volume of approximately 130,000 units and around 70 per cent are lower limb products [38].

China’s prostheses are known for their price competitiveness and responsiveness. For example, according to a supplier, the price of their comparable hydraulic knee joints can be 20 to 60 per cent of those from global brands. This is primarily due to China’s advanced supply chain and high production efficiency. Required materials can be sourced locally at low cost, resulting in shorter lead times for global procurement.

In China prostheses used to be classified as medical devices. However, certain below- knee (BK) prostheses were removed from the national medical device list in 2015, and certain above-knee (AK) prostheses were removed in 2020 [39] [40]. As a result, relevant products are no longer regulated or monitored by NMPA. Quality control for prostheses is now regulated only by the SAMR.

The National Rehabilitation Technical Aids Quality Supervision and Test Centre, under the Ministry of Civil Affairs, is assigned by SAMR to issue quality certifications and to conduct mandatory spot inspections [41]. For lower limb prostheses, the centre has established the national standard GB/T 18375, which leverages global prostheses standards, such as ISO 10328, and is used as the gold standard certification in domestic sales.