For the first time in 2018, NMPA (formerly CFDA) issued clinical trial incompliant companies report. In this Medical Device Clinical Audit Notice on September 12th, Siemens and Medtronic, along with 7 domestic manufacturers, have been found incompliance in clinical audit. This means that registration applications of these companies are to be reevaluated and run the risk of being rejected.
Please contact info@ChinaMedDevice.com to see if your CFDA registration experience long delays or the risk of being rejected.
Incompliant Companies:
· Siemens: thyrotropin receptor antibody
Reason: Inconsistent SOP regarding Blinding and Allocation Concealment in user facility; Medical history of 10 participants failed to provide
· Medtronic: drug-coated balloon
Reason: Inconsistent efficacy endpoints; Lab analysis failed to cover all participants
· 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 colum
· Tianjin H&J: disposable medicated cervical dilatation stick
· Nanjing Zhentai: multi-frequency microwave acupuncture and moxibustion therapy apparatus
· Guangdong Zhongneng: medical electron linear accelerator
For the complete list of trial hospitals and reasons, please email info@ChinaMedDevice.com.
NMPA (formerly CFDA) announced the total number of Voluntary Registration Withdrawals that happened from December 15th, 2017 to June 25th, 2018. There are 139 medical devices and IVDs registrations that have been voluntarily withdrawn due to inconsistent clinical data or other incompliance issues. Registrations from Beckman Coulter, Roche, Boston Scientific, Smith & Nephew and St. Jude were on the list.
For do’s and don’ts in the clinical audit, please click https://chinameddevice.com/problems-and-suggestions-for-medical-device-clinical-auditing-in-china/.
For webinar on NMPA (formerly CFDA) clinical trial & CER, please visit https://chinameddevice.com/clinical-trial-and-cer/
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About China Med Device, LLC
China Med Device, LLC (www.ChinaMedDevice.com) provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, RA, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. 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 250+ companies’ success.