List! 10 medical device clinical trials will be verified
Medical Network News June 26 A number of medical device clinical trials will be spot checked by the state. The list has been published. There are 10 in total.
On June 25, the State Food and Drug Administration issued a notice stating that, according to the key work arrangement in 2018, the State Food and Drug Administration extracted 10 applications for registration of capsule endoscope systems (acceptance number: CQZ1700095), and verified the authenticity of its clinical trial data. Compliance organization conducts on-site supervision and inspection.
The specific test schedule and spot checks of clinical trial institutions shall be notified separately by the Food and Drugs Auditing and Inspection Center of the State Food and Drug Administration. Since the issuance of this circular, the application for withdrawal of the above items by the registered applicant will no longer be accepted.
On July 10 last year, the former State Food and Drug Administration issued a notice and decided to organize the trial medical instruments The authenticity of the clinical trial data in the registration application, the supervision and inspection of compliance, the investigation and punishment of violations of laws and regulations in clinical trials, and the announcement of the supervision and inspection and the results of the treatment to the public.
On June 1st this year, the Office of the State Food and Drug Administration had publicly solicited opinions on the “Regulations and Decision Principles for Medical Device Clinical Trials”. This is a enterprise , Inspectors and data clinics need to understand the documents.
This document elaborates on the principles of medical device clinical testing and the principles for the determination of liability. With thisstandard At that time, we judged that it was not far from the normal sampling test nationwide. For details, see "Medical Machinery Clinical Test Large Sample Check-ups! 8 Cases Will Be Determined to Have Problems."
As early as July 22, 3 years ago, drug The storm of clinical trial data has officially come. The industry is in a haze and many companies automatically withdraw. Drug Registration Application, the previous investment has been played.
Because if you do not take the initiative to withdraw, once the clinical data is found to be a problem, it will be sentenced to not apply for registration again, and that the company will lose more. If you take the initiative to withdraw and do it again, you will have the opportunity to pass the review.
The industry admits that prior to this, the prevalence of counterfeit clinical data for drugs seriously affected the quality of medicines and seriously threatened people's lives. After that, clinical data fraud basically did not work, and the cost of clinical trials also increased dramatically.
After the storm operation, it was normal clinical trial sampling, random inspection, and clinical trial links. It also became strictly supervised by regulators like production, circulation, and use.
Since the first two years, the State Food and Drug Administration has started training the team of inspectors. Provincial Food and Drug Administrations also have recruiting inspectors. The future is only stricter.
Attachment: The first batch of medical device supervision and spot checks in 2018
product name
applicant
Undertake clinical trial institutions
Hip prosthesis - non-cemented femoral stem assembly
Zhejiang Kehui Medical Devices Co., Ltd.
Shao Yifu Hospital, Zhejiang University School of Medicine, Taizhou Hospital, Zhejiang Province, Jinhua Central Hospital
Capsule endoscope system
Shenyang Shangxian Medical System Co., Ltd.
Renji Hospital, Shanghai Jiao Tong University School of Medicine, General Hospital of Shenyang Military Region, People's Liberation Army
Thoracic aorta covered stent system
Beijing Huamai Taike Medical Instrument Co., Ltd.
General Hospital of PLA, Shandong Provincial Hospital, First Affiliated Hospital of Zhejiang University School of Medicine, Zhongshan Hospital of Fudan University, Second Xiangya Hospital of Central South University, Second Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Sun Yat-sen University, Fujian Medical College University First Affiliated Hospital, Ningxia Medical University General Hospital, Xijing Hospital
Absorbable hemostatic film
Beijing Daqing Biotechnology Co., Ltd.
Chinese People's Armed Police Force General Hospital, Peking University Third Hospital, Tianjin People's Hospital, Jinan Central Hospital
Disposable bilirubin adsorption column
Guangzhou Kangsheng Biotechnology Co., Ltd.
The 8th People’s Hospital of Guangzhou City, the Second Xiangya Hospital of Central South University, the First People’s Hospital of Foshan City
Disposable medicine containing cervical dilator
Tianjin Hejie Medical Devices Co., Ltd.
Tianjin Medical University General Hospital, Peking University Third Hospital
Medtronic, Inc. (Attorney: Medtronic (Shanghai) Management Co., Ltd.)
Zhongshan Hospital, Fudan University, People's Liberation Army General Hospital, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Sun Yat-sen University, First Affiliated Hospital of Chongqing Medical University, Affiliated Drum Tower Hospital of Medical School of Nanjing University, Shengjing Hospital Affiliated to China Medical University , Beijing Anzhen Hospital, Capital Medical University, Xuanwu Hospital, Capital Medical University, First Hospital of Peking University, First Affiliated Hospital of Fujian Medical University, Second Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Dalian Medical University, West China Hospital of Sichuan University , Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Peking Union Medical College Hospital of Chinese Academy of Medical Sciences, the Second Hospital of Tianjin Medical University, General Hospital of Tianjin Medical University
