Clinical experts at Inspirative Medical have an in-depth understanding of global clinical requirements for registering medical devices and IVDs. After a good understanding of your product and all necessary background information, we would tabulate all clinical requirements for major markets and present all options in each of these major markets.
China NMPA might not accept a clinical study accepted by the FDA due to its specific clinical study design requirements. Inspirative Medical would help you avoid this dilemma from the beginning. Our clinical experts would help you incorporate critical requirements from major markets into the study design, thereby maximizing the global acceptability of your clinical study.
If you have run a clinical study in one country and would like to use it to support the registration in another country, Inspirative Medical would pave the road for you. Specifically, we would first prepare a gap analysis to identify all areas from your clinical study documents that are not aligned with the country-specific requirement. Then we would either provide justifications or supporting information to close all gaps, hence increasing the acceptability.
Clinical trials are usually required for high-risk devices; however, we should explore the possibility of alternative pathways, such as clinical evaluation, to support your product’s registration. A powerful and convincing clinical evaluation document could save you millions of dollars from not running a clinical trial and deliver your products to the market much faster. Clinical experts have years of clinical evaluation experience and would like to help you achieve your goal sooner.
