Since the release of the Action Plan for Promoting Large scale Equipment Renewal and Consumer Goods Trade in (hereinafter referred to as Trade in in March this year, various regions across the country have responded by launching and approving large-scale medical equipment trade in projects. more…
According to data provided by the General Administration of Customs, the import quantity and amount of electron microscopes in China showed a significant growth trend in the first half of 2024. The data in this more…
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 |
