Since 28 August, the Comprehensive Department of the NMPA has been publicly soliciting opinions on the ‘Law of the People’s Republic of China on the Administration of Medical Devices (Draft for Opinion)’ (hereinafter referred to as the ‘Draft for Opinion’), with a deadline of 28 September 2024 for feedback. more…
On July 19, 2024, China NMPA published an announcement on imported medical devices. In this announcement, imported medical devices needed for prevention and treatment of life-threatening diseases now are allowed to apply for sales in designated hospitals without obtaining NMPA registration certificates.
| Submission type | Product classification | Average review time (days) | Average time of expert consultation (days) | Average time of deficiency response (days) | Total time (days) |
| Product registration | Class Il | 75 | 1 | 236 | 312 |
| Class III | 98 | 1 | 175 | 274 | |
| Class Il and III | 96 | 1 | 181 | 279 | |
| Change of registration | Class Il | 47 | 0 | 68 | 115 |
| Class Ill | 71 | 0 | 67 | 139 | |
| Class Il and III | 65 | 0 | 67 | 132 | |
| Renewal of registration | Class II | 21 | 0 | 3 | 24 |
| Class Ill | 24 | 0 | 3 | 27 | |
| Class Il and III | 23 | 0 | 3 | 26 |
On July 12, 2024, Guangzhou SIDECE released the world’s first capsule mobile gastroscope, which is the world’s first mobile capsule gastroscope system without a host, wearable devices, and can be applied in multiple scenarios on a large scale, filling the international gap. more…
Summary and statistics of H1 registration and filing information in the first half of 2024:
– Number of registered approved medical devices 12,363 items
– Number of medical devices approved for filing 16941 items
– Priority approval of 58 registered medical devices
– Innovative Approval of Registered Medical Devices 82 items more…
