The rigorous control of ophthalmic health products in China is centralized under the National Medical Products Administration (NMPA), which oversees the classification, registration, and post-market surveillance of drugs, medical devices, and health supplements. For supplements, the NMPA defines strict standards for ingredient usage, dose limits, and efficacy claims, classifying them distinctly from regulated pharmaceuticals or medical devices. Products must undergo a comprehensive registration or filing process, depending on their risk level and claimed function.

The registration dossier requires extensive technical documentation, including the Product Technical Requirement (PTR) and detailed test reports to demonstrate compliance with compulsory national and industry standards. A core focus of the regulatory body is ensuring the integrity and safety of the supply chain through mandatory Quality Management System (QMS) audits, which examine the manufacturer's facilities, processes, and quality control capabilities. Furthermore, all claims of efficacy must be substantiated by scientific evidence, with increasing scrutiny applied to the verification of ingredient purity and stability. This stringent regulatory environment is designed to build consumer trust and ensure that products meet defined, evidence-based performance thresholds, as explored in regulatory analysis reports, such as the China Eye Health Supplements Market Analysis.