Regulatory Consideration for Animal Study of Medical Device / 中国医疗器械杂志

Animal study plays a key role to evaluate the safety and effectivity of medical devices. This study aims to share evaluated consideration on the role, general principles, necessity, study design and quality management system of animal study, in order to improve the quality of animal study and reduce unnecessary study.

Evaluation of Lubrication Coatings for Intravascular Catheters, Wires, and Delivery System / 中国医疗器械杂志

Lubrication coating is widely used to reduce the friction between the interventional devices and the blood vessels, improves the surface biocompatibility of the interventional device, and also brings the coating stability problems and related risks. This paper describes the coating-related content from the equipment description, performance verification, technical requirements, etc., to reduce the risk of the coating to an acceptable level.

Bacterial Endotoxin for Intrathoracic Medical Devices Requirement Revisited / 中国医疗器械杂志

Bacterial endotoxin is considered as one of the critical risk factors in medical devices, especially implanted devices that directly or indirectly contact with blood circulating system. In that case, endotoxin limits for implanted medical devices is important in determine the safety of medical devices. According to GB/T 14233.2-2005, the requirements of endotoxin index for intrathoracic medical devices is 2.15 EU per device. However, the definition of "intrathoracic medical devices" is vague. Specifically, "for cardiovascular system application" instead of "intrathoracic application" is more reasonable. With the deeper understanding of the risk of endotoxin in medical devices and considering the internationally accepted standards, the limits of endotoxin in medical devices for cardiovascular system application is acceptable at 20 EU per device.

The Enhancement of Ultrasonic Visibility and Technical Requirements of Needles and Catheters / 中国医疗器械杂志

Ultrasound guided needle biopsy or catheterization is a rising operation in clinical diagnosis and treatment. However, poor visualization under ultrasound is the main disadvantage of this technique. This paper summarized the basic methods used to solve such problem, as well as the corresponding product technical requirements.

The research progress of transcatheter aortic valve replacement / 中国医疗器械杂志

During the past years transcatheter aortic valve replacement has evolved to a promising technique for the treatment of the patients who suffered from severe aortic stenosis, the progress and basic consideration on clinical study have been summarized in the article.

The authorized considerations on the pre-clinical study of drug-eluting coronary stent system / 中国医疗器械杂志

China Food and Drug Administration didn't issue any guideline on the pre-clinical study of drug-eluting coronary stent system, the basic requirement of the authorized administration was summarized to help manufacture prepare the document during the registration process.