Xinmin Evening News (Reporter Qiu Yingqiong) Recently, Wei Kai, the registration regulatory manager of Philips Ultrasound (Shanghai) Co., Ltd., obtained the “medical device registration certificate” in the business hall of Shanghai Drug Administration. This is also the first “import-to-local” product in Shanghai after the State Food and Drug Administration issued the “Announcement of the State Food and Drug Administration on Matters Concerning the Production of Imported Medical Device Products in Chinese Enterprises” in September last year.
“This is of great significance to the realization of localized production of imported medical devices. In the past, if Hongyu imported medical devices were to be transferred to domestic production, it may be necessary to initiate local clinical trials, from designing clinical trials to recruiting clinical trial subjects and summarizing data in hospitals. The process has taken at least half a year, and now the national medical device registration policy gives Hongyu more choices,” Wei Kai said.
The “dividends” of Circular 104 have attracted many companies. Xu Bin, the quality director of Boston Scientific, told reporters that Poco is currently holding more than 300 imported equipment registration certificates. It is very beneficial for imported products to irradiate Chinese patients as soon as possible. Therefore, Hongyu am very looking forward to the innovative services of the Shanghai Drug Administration in the New Policy of the State Drug Administration.