China issues new IVD medical device clinical trial guidelines

Moving to standardize and improve its process of assessing clinical data of new in-vitro medical devices, China’s National Medical Products Administration (NMPA) in late November published new draft guidelines for IVD clinical trials. Firms either renewing or applying for new product registrations will be required to meet the new guidelines, once they are implemented as expected this year (2019).

Meeting the new guidelines, which require fresh samples and a statistically significant sampling size, is likely to increase clinical trial costs for firms. The new requirements mandate using only testing labs approved by the NMPA, conducting the clinical trials at a minimum of three different sites, retaining clinical data for ten years and employing fresh instead of stored samples. In addition, the new requirements mandate ensuring all samples are traceable with unique codes and are retained until the commercialization of the product, and ensuring that the sample size for each trial is statistically significant – a number that will vary.