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.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

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