The technical arm of the CFDA has announced the first successful applicant going through the Innovative Device Pathway. The lucky first is an absorbable dural sealant developed by a domestic manufacturer.
As part of the criteria for the Innovative Device Pathway, this device must be first of its kind in China with an approved Chinese patent or an application passed preliminary assessment. This public announcement allows any competitors or interest parties to challenge the decision of its qualification as an innovative device. Should there be no objections submitted by 24 May 2014, we would expect this dural sealant to become what Chinese calls “the first person to take crabs for food”, meaning the first to try something untried before.
June 2014 update:
A second batch of 6 has been announced by CFDA here, including:
- Impermeable medical coating system for Endocranium use
- Reagent kit for detecting trisomy 21, trisomy 18 and trisomy 13
- Gene sequencing equiment
- Dual-channel implantable neural stimulator programmable through radio signal
- Occluder system for the left atrial appendage
- Artificial heart valve system via percutaneous access
CFDA will be finalising the above applications if their innovative status are not challenged by 3 July 2014.