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3. Clinical Evaluation Strategies Clinical studies are the decisive point for the registration of innovative Class III devices. The NMPA reports provide clear examples of
Patent Background One of the patents for medium-term corneal preservation solution (Application No. CN200410091007.5, filed on November 15, 2004) was submitted by Shandong Eye Institute.
On June 27, 2025 NMPA approved the corneal preservation solution, developed by the team at Shandong First Medical University Affiliated Ophthalmic Hospital (Shandong Eye Hospital)
NMPA released the Guideline for Classification of Medical Devices for Myopia Control and Amblyopia Treatment Involving Light Sources on July 16, 2025. The new guideline
II. Regulatory Landscape and Global Market Integration NMPA The NMPA classifies punctal plugs as Class III medical devices under the code 16-07-05, denoting the highest
Devices and Equipment for Cataract Treatment The success of cataract surgeries hinges on the use of advanced surgical equipment. The main technology driving cataract surgeries
Introduction China’s healthcare market, one of the largest and most rapidly growing in the world, presents numerous opportunities for foreign manufacturers, particularly in specialized fields
China’s ophthalmology market is on the cusp of transformation, presenting lucrative opportunities for global device manufacturers. As one of the fastest-growing healthcare sectors in the
NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” on June 16, 2022. The document suggests manufacturers how to choose clinical evaluation
The NMPA issued the “Optimizing Mandatory Standards for Medical Devices (Draft)” on January 5, 2022 for feedback. Feedbacks need to be submitted by February 10.
The NMPA published the “Catalog of Medical Devices Prohibiting of Entrusted Production” on November 17, 2021, providing the scope of 22 devices which are not allowed for contract manufacturing.
NMPA issued the “Artificial Intelligence Medical Software Classification Guideline” on July 8, 2021, to direct manufacturers for the classification and the corresponding clinical data and