On May 11th, 2018, the China National Health Commission, together with other 5 authorities including CFDA, published the first catalog of total number of 121 rare diseases. This is the first time in China to define the rare diseases. 21-Hydroxyulase…
Category: News
A Brief Summary of CFDA Registration in 2017
In 2017, CFDA approved 5993 domestic Class II initial registrations and 867 domestic Class III initial registrations. In contrast, CFDA only approved 389 imported Class II initial registrations and 189 imported Class II initial registrations. Imported Class III initial registration…
None CFDA registered but clinically urgent-need medical devices are allowed to be used in Hanan China
On May 9, 2018, the government of Hainan Province China issued the notice and guidance on the importation and use of none CFDA registered but clinically urgent-need medical devices in Hannan Boao Lecheng International Medical Tourism Pilot Zone. This guidance…
CFDA Issued Two Guidiance for Coronary Artery Drug Eluting Stents
On May 11, 2018 CFDA issued two guidiance for industry (CFDA Annoucement No. 21 in 2018). One is Preclinical Study Guidelines for Coronary Artery Drug Eluting Stents (DES). It guides industry on DES functional study and preclinical study. The other…
General Manager of J MedTec participates the Sino-Israel Technology Innovation Cooperation Forum as a round-table speaker
Shenzhen, China – Sino-Israel Technology Innovation Cooperation Forum in Shenzhen on May 15th, 2018 attracted more than Chinese and Israeli 300 entrepreneurs to promote the communication and collaboration between both countries. The general manager of J MedTec Dr. Zhaohui Li…
J MedTec forms strategic partnership with HQ Plus Idea Park in Shenzhen
Shenzhen, China – J MedTec and HQ Plus Idea Park are teaming up to meet the needs of a rapidly growing healthcare industry in Shenzhen through a targeted partnership. J MedTec will be the exclusive regulatory and clinical consulting service…