NMPA report on the registration of medical devices in China
On April 1, 2016, the China Food and Drug Administration (NMPA) published its report on the registration of medical devices in 2013, 2014 and 2015.
In 2015, the NMPA approved a total of 7,530 registrations for Class II and III products. This is a significant decline compared to previous years 2013 (7,875) and 2014 (8,834). In addition, 1,297 applications were rejected by the NMPA in 2015.
The decline is due to the following causes:
- Overhaul of the framework conditions for approval
- Stricter review of medical technology requirements
- Higher fees for the registration of Class II and III devices
- Extension of clinical trials and thus extension of registration time
In 2015, approvals were divided between 64% medical devices and 36% IVD. There were 2,707 new registrations, 4,072 renewals and 751 extensions. In addition, the NMPA officially listed 2,488 Class I products from foreign manufacturers in 2015.
China continues to focus on the supply of high-end, high-cost medical devices from abroad. The top five product groups for the registration of Class II and III foreign medical devices in 2015 were:
- Optical and endoscopic instruments (474)
- Implants and artificial organs (448)
- Dental equipment and instruments (298)
- Electronic equipment for hospitals (238)
- Medical polymers and products thereof (200)
- According to the NMPA report 2015, the USA, Germany, Japan, Great Britain and Korea were the leaders in the registration of Class II and III foreign products in China (including IVD).
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