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China’s current nmpa medical device classification system specifies that classifications should be based on the device category, subcategory. The nmpa issued the “guideline on inspection of quality management system for medical device registration” on october 10, 2022, implementing from the day of release. What is china nmpa registration and classification system for medical device and ivd
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The classification of medical device determines documentation required for china nmpa registration. These standards were revised or newly. China med device (cmd) has brought a great deal of knowledge and understanding to our team to help us navigate the complexities of bringing a product to market in china
Nmpa published the new draft “medical device manufacturing quality management standards” on january 15, 2025, for feedback.
Class i, class ii, and class iii Nmpa issued the “2025 medical device industry standards revisions plan” The nmpa released 49 national standards and 90 industry standards for medical devices and in vitro diagnostics (ivds) in 2024