NMPA definition of software as a medical product (SaMD)
Software as a Medical Device (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device, and operate on general purpose computing platform, according to NMPA guidance “Medical device software registration technical review guidance” (released in 08-05-2015). Examples of SaMD includes PACS, the Central Patient Monitoring Software, the Holter Analysis Software, and the Ophthalmic Microscope Image Processing Software, etc.
NMPA regulates the way the manufacturer publishes their software version. Manufacturer should clearly state the software naming convention and include the Released Version in the IFU, PTR and test reports. Please note that a software Released Version does not have to be the Complete Version. For example, a Complete Version scheme may be X.Y.Z.B which correspond to major changes, minor changes, maintenance (patches), and the revision number; while the Released Version could just be X.Y.
The Released Version is required to be documented in the registration as well as displayed in the software start screen, any changes to the released version would trigger a change submission. However, when changes only affect the Complete Version but do not alter the Released Version, manufacturers will only need to manage changes through its internal quality system and report changes next time along with a renewal application or together with other big changes.
Determine classification of a software using NMPA Medical Device Classification Catalog is the first step. In general, if a software has clinical data auto-analysis ability based on deep learning or artificial intelligence algorithm, or aids in diagnosis for medical decision, it is likely to be classified as class 3. However, if it only transfers and processes data without clinical data analysis or its analyzed data is only for clinical reference, there is a high likelihood it will be labeled as a class 2 device. If the manufacturer cannot identify appropriate classification from the catalog, they will need to submit an application to NMPA for a formal determination on device classification.
SaMD Type Testing
Similar to other types of medical devices, software as a Medical Device also needs to conduct type testing during the pre-market registration process. In addition to regular deliverables (e.g IFU, PTR, label) that are required to be submitted to NMPA test centers for the testing application, applicants should also provide a “SaMD testing instruction”, in which software modules, functionalities, principles, etc. are clearly stated.
SaMD Clinical Evaluation
Clinical evaluation is another essential part of the registration process. Whether the product is a SaMD or software as a part of a medical device, it needs an appropriate clinical evaluation path based on NMPA Medical Device Clinical Evaluation Guidance. For SaMD that aid in making a definitive diagnosis or has utilized brand-new core algorithm or functionalities, it is possible that NMPA would require a local clinical trial. We recommend applicants seek professional advice for clinical considerations and the least burdensome clinical approach if possible.
NMPA SaMD Guidance
As we see software technologies are rapidly changing, NMPA is working in a progressive way to better align regulations with development needs. NMPA has issued many rules outlines their recommended way of developing and maintenance of software medical devices, including meeting Chinese standards GB/T 25000.51 “Systems and software engineering — Systems and software Quality Requirements and Evaluation (SQuaRE) — Part 51: Requirements for quality of Ready to Use Software Product (RUSP) and instructions for testing.” Due to the unique features that Software as a Medical Device has, regulators across the world need to make better effort to address the challenges with regulating SaMD.
The FDA and IMDRF have developed several guidelines in an effort to make more universal, consistent rules for standalone software. However, those guidelines do not always apply to China as NMPA has demonstrated increasing considerations for software evaluation methods and requires applicants to submit a standalone software description report, a cybersecurity description report, and a software external environment assessment report. Device manufacturers should be in constant contact with NMPA and experienced consultants about the software regulations, and ensure that they have proper processes in place to meet NMPA’s regulatory expectation continuously.
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