‘Same Type,’ SaMD and AI
It is also important for manufacturers to remember that their product’s application will still need to include a ‘same type’ comparison, even if the product category is found on the Exemption List. The ‘same type’ process, like the US FDA’s Predicate Device 510(k) program, requires evidence that the product’s technology, intended uses and method are all similar to an already approved product and it has been shown to be safe and effective.
When it comes to Software as Medical Devices (SaMD) and AI Software, even though the new product category, “Screening and analysis software for diagnosing diseases through analysis and calculation of clinical, biochemical and immune measurement data,” technically covers them, manufacturers will still need to show equivalence to an already registered product. This is typically where manufacturers can run into problems as companies do not usually have access to the competitive products’ specifications that are needed to make a successful substantially equivalent argument.
A Brief History of the Clinical Trial List
First released in 2014, the original list included 488 Class II and 79 Class III medical devices and in-vitro diagnostics (IVDs). The list has since risen to 1,003 product types and another 64 products are being considered for addition this year. The Exemption List is one of the many solutions the NMPA (formerly the CFDA) has implemented in recent years to help manufacturers better determine their regulatory burden up front. Foreign manufacturers had become frustrated with China’s regulatory requirements due to their inability to understand, and plan for, what will be needed during the application process. Previously, the NMPA (CFDA at the time) were more lenient with clinical requirements and would accept Clinical Evaluation Reports (CERs) in lieu of clinical trials, thus reducing the registration costs significantly. However, requirements became stricter and began to catch many manufacturers off guard causing some manufacturers to shy away from the Chinese market until more transparency could be provided. The Exemption List is applicable to foreign and domestic companies alike.
In addition to the extensive Clinical Trial Exemption List, the NMPA has also implemented an online process where manufacturers could speak with reviewers early on in their decision-making process to learn exactly what would be needed.