The GCP requirements on medical devices have intensified. On June 25, CFDA issued the first notification in 2018 for the upcoming clinical inspections for 9 medical devices and an IVD. Siemens and Medtronic are on the list. The inspections will be conducted at 46 hospitals over China where the devices are undergoing clinical trial.
For information on clinical sites, please email info@ChinaMedDevice.com.
Siemens: thyrotropin receptor antibody
Medtronic: drug-coated balloon
Zhejiang Canwell Medical: hip prosthesis
Shenyang Shangxian: capsule endoscope system
Beijing Percutek: thoracic aortic covered stent system
Beijing Datsing: absorbable hemostatic membrane
Guangzhou Koncen Bioscience: disposable Bilirubin adsorption column
Tianjin H&J: disposable medicated cervical dilatation stick
Nanjing Zhentai: multi-frequency microwave acupuncture and moxibustion therapy apparatus
Guangdong Zhongneng: medical electron linear accelerator
China's State Council announced Medical Device Amendment on June 25. For GCP requirements in the Decree, please email info@ChinaMedDevice.com.
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About China Med Device, LLC
China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, QA and post market compliance. We are certified as legal agent. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 200+ companies' success.
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Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------