On May 31, National Medical Products Administration (NMPA) officially issued the "2018 Medical Device Registration Work Report". The report details the acceptance of medical device registration applications, the approval of medical device registration, and the approval of registration for innovative medical devices.
The CIRS summary report outlines the following points:
◆ By 2018, NMPA summarized the Clinical Trial Exemption Catalogues for Medical Devices, and released the newly revised version of Clinical Trial Exemption Catalogues for Medical Devices, which exempts a total of 1,254 types of medical devices from clinical trials.
◆ By 2018, the medical device registrant system will be piloted in the Shanghai, Guangdong and Tianjin free trade zones.
◆ By 2018, the medical device Marketing Authorization Holder (MAH) was piloted in the Shanghai, Guangdong and Tianjin free trade zones.
◆ A total of 2,125 imported medical devices were accepted for registration. Compared with 2017, the total number of imported medical devices increased by 3.3%. Among them, 1,144 were applications for medical device registration and 981 were applications for in vitro diagnostic reagent registration.
◆ The number of imported Class III medical devices application was 2,101, a decrease of 9.4% compared with 2017. Among them, 1,820 were applications for medical device registration and 281 were applications for registration of in vitro diagnostic reagents.
◆ In 2018, NMPA approved a total of 5,528 medical device registration, certificate renewal and certificate alternation. Compared with 2017, the total number of registration approvals decreased by 38.0%. Among them, 1,128 were registration for the first time, 2,150 were registration renewal, and 2,250 were registration alternation.
◆ The top five domestic Class III medical devices are:
1. Non-active implant devices
2. Infusion, care and protective devices
3. Medical imaging devices
4. Patient-carrying devices
5. Neurological and cardiovascular surgical instruments
◆ The top five imported medical devices are:
1. Medical imaging device
2. Clinical testing equipment
3. Non-active implanted instruments
4. Medical examination and monitoring equipment
5. Dental equipment.
◆ In 2018, medical devices from the United States, Germany, Japan, South Korea, and Switzerland ranked the top five in the number of first-time registrations of imported medical device. The number of registered products from these countries accounted for approximately 75.6% of the total number of first-registered imported medical devices in 2018. Compared with 2017, the number slightly increased.
◆ In 2018, NMPA received 316 applications for special approval as innovative medical devices, completed 310 reviews, and allowed 45 products entered the special approval path for innovative medical devices. Between those products, 21 of them were approved to enter Chinese market. Among them, there are 7 active medical devices, 5 non-active medical devices, and 9 in vitro diagnostic reagents.
China Medical Device Regulation Related Resources provided by CIRS:
China NMPA Medical Device Filing and Registration Consulting
Clinical Trial Consulting
Medical Device GMP System Assessment
China Medical Device Regulation Training
Guideline: Medical Device Registration in China
Annual Report: Medical Device Market in China