Fosun Pharma 2021 Annual Results Announcement
Fosun Pharma Announces 2021 Interim Results Innovative Products Continuously Launched with International Operation Capability Fu
On February 28, 2019, the second BodyTom® of the Chinese People's Liberation Army General Hospital (Beijing 301 Hospital) was successfully installed in our hospital area! So far, 301 Hospital has installed 2 BodyTom® and 1 CereTom®, a total of 3 mobile CT equipment.
At the beginning of the new year, the US and China Mutual Benefit successfully obtained the exclusive national agency rights for EOS. On this occasion, the company's product department, marketing department, maintenance department, and sales department formed a small team together with Didier, gene
From 2004 to 2018, as the exclusive agent of the American Intuitive Surgery Company in mainland China and Hong Kong, Sino-American Mutual Medical Co., Ltd. introduced the Da Vinci surgical robot to Hong Kong, China in 2005 and introduced it to the Chinese mainland market in 2006. At present, Da Vin
Unfortunately, it is NOT legal unless the manufacturers have branches with qualification in China to deal with the registration issues. Otherwise, it is a must-do that manufacturers overseas are required to appoint a Chinese agent for the medical device registration.
Regarding the registration fee for NMPA, as for the imported medical devices, the registration of Class II medical device needs 210,900 CNY while that of Class III costs 308,800 CNY. In addition, other kinds of possible fees should be taken into consideration such as fees of document translation, clinical trial, and so forth.
After the registration materials are accepted by NMPA, technical review for Class II medical devices takes 60 working days to process while for Class III medical devices, technical review takes 90 working days. If supplementary materials are required by NMPA, manufacturers are obliged to conduct submission within one year, otherwise the review may result in termination.
MDs with CE or FDA certificate are feasible to enter SAR without NMPA certificate. As for the Greater Bay Area and Hainan province, MDs marketed in HK or MO as a premise can enter the pilot areas if designated medical institutions in pilot areas are willing to procure medical devices out of clinical urgent needs under the approval of local government.
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