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2024 China NMPA Bluebook is here:

Four AI Software Guidelines Announced in One Day

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Guidelines for AI Software

The NMPA published four guidelines for AI software on July 10, 2023, propelling China to be the leader in the AI applications.

Full List of Guidelines for AI Software

The review key points for the following AI software are issued as follows:

  1. Ultrasound Imaging Artificial Intelligence Software (Process Optimization)
  2. Performance Evaluation on Artificial Intelligence Analysis Software for Pathological Images
  3. Clinical Evaluation on Artificial Intelligence Analysis Software for Pathological Images
  4. Performance Evaluation on Artificial Intelligence Analysis Software for Blood Disease Flow Cytometry

Read our comprehensive review of the “Key Points of Ultrasound Imaging Artificial Intelligence Software”

View the “Guideline for Artificial Intelligence Medical Devices”

About China Med Device

China Med Device 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, clinical standards, IVDs draft guidelines, eRPS, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.

Feel free to contact us by email with any questions you may have about any related items.

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