China’s National Medical Products Administration (NMPA) announced on April 15 that it has suspended the import, sale, and use of artificial intraocular lenses produced by Indonesia’s Rohto Laboratories due to significant quality and safety concerns.

Policy Breakdown

• Deficiencies Identified: During a remote inspection, the NMPA found severe flaws in the company’s quality management system, particularly in change control, product testing, and validation processes.
• Regulatory Basis: The decision aligns with the Medical Device Supervision and Administration Regulations and the Medical Device Production Supervision and Administration Measures.
• Public Safety Priority: The move underscores China’s commitment to safeguarding public health amid increasing medical device scrutiny.

Market Implications
The suspension could disrupt supply chains for intraocular lenses, a critical component in cataract surgeries. Analysts at China Healthcare Market Research suggest that domestic producers and alternative international suppliers may see short-term demand increases.

Industry Impact
This serves as a warning to medical device manufacturers on the importance of adhering to China’s stringent quality standards. Companies are urged to strengthen quality management systems to avoid similar restrictions.

Looking Ahead
Stakeholders should monitor whether the suspension prompts broader quality audits of imported medical devices. The incident highlights the need for robust compliance strategies in China’s medical device market.-China Health Reform Pulse

Policy Source: https://www.nmpa.gov.cn/ylqx/ylqxggtg/20250417153039134.html