2017 Annual Report for Medical Deivce Registration in China

China Food and Drug Administration (known as CFDA) has issued the Medical Device Registration Report in 2017 on March 28th 2018.

In 2017, CFDA conscientiously implements the Regulations on the Supervision and Administration of Medical Devices, and Continue to deepen the reform of the medical device review for technical review and approval system, further strengthen the supervision and management of the medical device registration, strengthen clinical trials register on-site inspections and supervision and spot check, improve the quality and efficiency of the review of medical device registration approval.

1. Working condition of medical device registration

- Improve regulation system of medical device registration management

- Promote reform for technical review and approval system for medical device

- Strengthen the supervision and administration of medical device registration

2. Acceptance situation of medical device registration application

In 2017, CFDA has accepted 6834 applications of medical device registration, in which: 1429 first registration applications, 3306 renew registration applications, and 2099 application of licensing item change. A 23.4% reduction compared to the application number of 2016.

3. Review and approval situation of medical device registration

In 2017, CFDA has reviewed 8579 medical device registration, in which the number of first registration is 1507, the renew registration is 5218 and the licensing item change is 1854.

CFDA has approved 8923 medical device registrations in 2017, it is 3.1% rose compared to the approved total number of 2016.

4. Innovative medical devices and other products review and approval situation

CFDA has accepted 273 innovative medical device applications and approved 12 innovative medical devices in 2017.

5. Other registration management conditions.

There were 18582 domestic class II medical device registrations approved via local food and drug administrative institute, in which the number of firs registration is 6605, the renew registration is 7436 and the licensing item change is 4541. A 19.5% rose compared to the approved total number of 2016.

In 2017, CFDA has recorded 2315 imported class I medical device filling, and 13203 domestic class I medical device filing.

2017年度医疗器械注册工作报告 http://www.sfda.gov.cn/WS01/CL0845/227097.html