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How are Medical Devices Classified? Here is the Summary of our Catalogs

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With the rapid development of the industry and continuous emergence of new technologies, new materials and new products, the “Medical Device Classification Catalog”, effective from August 2018, is in the process of real-time dynamic adjustment. The latest changes were that certain neurosurgical and cardiac surgery devices are down classified from Class III to Class II in March 2022.

China Med Device, LLC summarized the classification and definition of medical devices and IVDs, to direct applicants for registration application.

List of our Classification Catalogs

  1. Medical Devices Classification Catalog (August 31, 2017)
  2. Adjustment of the “Medical Device Classification Catalog” (December 18, 2020)
  3. Classification and Definition of Recombinant Collagen Medical Products (April 15, 2021)
  4. Work Procedures for the Dynamic Adjustment of the Medical Devices Classification (May 8, 2021)
  5. Classification and Definition of Artificial Intelligence Medical Software Products (July 8, 2021)
  6. Class I Medical Device Product Catalog (December 31, 2021)
  7. Adjustment of the “Medical Device Classification Catalog” (March 22, 2022)
  8. Adjustment of the “Medical Device Classification Catalog” (March 30, 2022)

About China Med Device, LLC

China Med Device, LLC provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our regulatory services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.

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