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…
Recently, Shanghai intends to set up a total size of 89 billion yuan of three industrial pioneer mother fund. And this is the latest big contribution from a major domestic city following Beijing’s release of a new batch of industrial investment funds with a total size of 50 billion yuan. Among them, 21.5 billion yuan will be invested in the field of biomedicine – innovative drugs and high-end preparations, high-end medical devices, biotechnology, high-end pharmaceutical equipment and other fields. more…
