Challenges in entering LMIC markets

Several challenges also exist for exports to LMICs. For example, Chinese suppliers, in general, still lack information on LMIC demand, needs and opportunities given the language barrier and the lack of available information. Chinese assistive product manufacturers are relatively small, so few have a dedicated sales team specifically targeting the LMIC markets. Also, the suppliers face fierce domestic and international competition with homogeneous products.

The expansion of assistive product exports faces several technical and procedural challenges related to standards, certification, and verification processes. In China, some assistive products are subject to compulsory national standards (GB), while others follow voluntary standards (GB/T), allowing for broader market access but resulting in varying degrees of adherence [27]. Product inspection mechanisms, such as spot checks, are in place but may not always reflect the full scale of production. Internationally, while certifications like CE and ISO are widely used, the credibility of certification bodies can vary, and there may be gaps between certified distributors and their upstream manufacturers. Differences in technical standards, classification systems, and certification expectations between China and other countries—particularly regarding medical device designation—can also create complexities for export, often requiring

16

suppliers to obtain additional documentation such as ““Certificate of Free Sale 4” or certification tailored to each market.