Second Overseas Innovative Medical Device in 2020 Approved via Green Channel

On 14.05.2020, the NMPA (National Medical Products Administration) granted the fast-track approval to the global oncology firm Novocure for the registration of Optune, the first tumor-treating fields device to be approved in China to treat glioblastoma.

Optune is only applicable to treat patients, aged 22 or over, with histologically-confirmed glioblastoma multiforme (GBM). Also, it is the first device in China to utilize electric fields for cancer therapy by tuning specific frequencies to disrupt cell division, whilst causing minimal damage to healthy cells.

After the fast-track approval of this new innovative medical device in China, the NMPA will continue to strengthen its measures for post-market surveillance.

On 23.04.2020, the CMDE (Center for Medical Device Evaluation) of NMPA (National Medical Products Administration) announced (No.5-2020) the fast-track approval for Edwards Lifesciences’ transcatheter valve repair clip device, utilizing the special review procedure.

There are three types of fast track channels to encourage innovation and deal with unmet medical needs in China: Innovation Approval, Priority Review, and Emergency Approval. Feel free to request a quotation from us to check if your product qualifies for NMPA registration via a fast track channel.

By Jacky Li. Contact Cisema to learn more.