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.
This approval is significant because of its rarity: it is difficult for a product to even be considered for the approval process, let alone be approved. The announcement provided no further detail about why the product was able to utilise the special review procedure (announcements by the CMDE generally don’t).
Set out below are some statistics relating to approvals via the Green Channel for the last few years. For comparison, the NMPA accepted a total of 3,511 domestic and 5,593 overseas registration applications in 2019.
NMPA Registered Innovative Medical Devices via the Green Channel
As of 31.12.2019, a total of 73 innovative medical devices had been registered via the Green Channel by NMPA.
| Year | Local Innovative Medical Device Registered | Overseas Innovative Medical Device Registered |
| 2014 | 1 | 0 |
| 2015 | 9 | 0 |
| 2016 | 11 | 0 |
| 2017 | 12 | 0 |
| 2018 | 21 | 0 |
| 2019 | 18 | 1 |
Approved Innovative Medical Devices to apply for NMPA registration via the Green Channel
As of 31.12.2019, a total of 233 innovative medical devices had been approved to apply for NMPA registration via the Green Channel.
| Year | Local Innovative Medical Device Approved | Overseas Innovative Medical Device Approved |
| 2019 | 21 | 8 |
| 2020 | 11 | 1 |
By Jacky Li. Contact Cisema to learn more.
