Clinical Exemptions for SaMD in China

In the China National Medical Products Administration (NMPA) Classification Catalog, SaMD can be Class II and III; it cannot be Class I.  This means that not all SaMD will require clinical trials and may fit into clinical exemptions for SaMD in China.  According to Medical Device Clinical Trial Exemption Catalog issued on September 30, 2018, seven SaMDs are exempted from clinical trial:

  1. Medical image storage and transmission system software
  2. Medical image processing software
  3. Data processing software
  4. Trace analysis software
  5. Allergen semi-quantitative analysis software
  6. Radiotherapy record and verification system software
  7. Radiotherapy contour delineation software

Keep in mind that China NMPA classification is based on clinical indications instead of device type, which leaves space for negotiation with NMPA.  China NMPA can review your IFU and your home-country-approval documents to determine the classification, clinical exemption status and regulatory pathway in China.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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