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2025 China NMPA Bluebook is here:
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 is the phacoemulsification system, which
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 such as ophthalmology. With a
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 country, ophthalmology is driven by
Case Study: Percutaneous Coronary Intervention (PCI) The centralized procurement reforms under the DRG/DIP framework have significantly impacted the costs associated with Percutaneous Coronary Intervention (PCI) procedures. While there have been
Under China’s regulatory framework for medical devices, innovative neurosurgical devices, due to their technical complexity and high application risks, must undergo stringent approval processes. This article, using three specific examples—neurosurgical
China’s NMPA issued a notice titled “Information Collection from Enterprises and Institutions Related to the Preparation of the Guideline for Intracranial Coils and Guideline for Stent Retrievers” on May 17,
The NMPA released the final version of “Registration Guideline for Radiofrequency Aesthetic Devices” on April 12, 2023. The draft document was released on August 26, 2022, for feedback. The radiofrequency
The NMPA issued a notice summarizing device approvals in January 2023. In total of 23 imported Class II and III were approved, among them are two implantable cardiac resynchronization cardioverter
The NMPA granted innovation approval to Boston Scientific for the Sentinel Cerebral Protection System on November 2, 2022. The device belongs to “first-of-its-kind in China” scenario. CMDE released the review
The NMPA released the “Draft Guideline on Continuous Glucose Monitoring System” on September 28, 2022, for feedback. Feedback needs to be submitted by October 14, 2022. Highlights of the NMPA
The NMPA reclassified 27 medical devices and modified intended use for some with an announcement on March 30, 2022. Among them, 16 devices are applied in cosmetic surgery. From April
The NMPA issued the “Guideline of Drug-coated Balloon Dilatation Catheter (draft)” today on June 22, 2022, collecting public opinions. Feedbacks need to be submitted by July 22, 2022. Referring to
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