NMPA’s UDI Requirements in China for Medical Device Manufacturers
NMPA had issued rules for Medical Device identification under Order 66, released in October 2019, which states that medical devices marketed in China shall comply with UDI regulations and implementation plan.
China New Policy Pushing Generics over Brands
On Tuesday April 3rd, 2018, the Chinese government published a new policy that promotes the usage of generics over brands in China. As an incentive, the qualified generics companies will be considered as high-tech enterprises, and therefore will be imposed a corporate tax rate of 15% instead of 25%. Additionally, generic that pass the quality […]
CFDA New Clinical Data Requirements for Foreign medical devices
CFDA has proposed changes to Order 650 that would exempt additional types of Class II and III medical devices and IVDs from clinical trial requirements, and allow greater acceptance of clinical data from foreign countries in registration applications. The main changes to CFDA foreign clinical data acceptance criteria are as follows: Foreign clinical trials must […]