1. Definition of medical devices
According to the "Regulations on the Supervision and Administration of Medical Devices" (Order No. 650 of the State Council of the People's Republic of China) Chapter 8 Supplement: The definition of medical devices refers to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials used directly or indirectly on the human body And other similar or related items, including the required computer software; Its utility is mainly obtained through physical and other means, not through pharmacology, immunology or metabolism, or although these methods are involved but only play an auxiliary role; its purpose is:
(1) Diagnosis, prevention, monitoring, treatment or alleviation of diseases;
(2) Diagnosis, monitoring, treatment, mitigation or functional compensation of injuries;
(3) Inspection, substitution, adjustment or support of physiological structure or physiological process;
(4) Life support or maintenance;
(5) Pregnancy control;
(6) Provide information for medical or diagnostic purposes by examining samples from the human body.
2. Classification of medical devices
The state implements classified management of medical devices according to the degree of risk.
The first category is low-risk medical devices, and the implementation of routine management can ensure their safety and effectiveness.
The second category is medical devices that have moderate risks and require strict control and management to ensure their safety and effectiveness.
The third category is medical devices that have higher risks and require special measures to strictly control and manage them to ensure their safety and effectiveness.
To evaluate the risk of medical devices, factors such as the intended purpose, structural features, and use methods of the medical device should be considered.
3. the classification catalog of medical devices
The Food and Drug Administration of the State Council is responsible for formulating the classification rules and classification catalogs of medical devices, and according to the production, operation and use of medical devices, timely analyze and evaluate the risk changes of medical devices and adjust the classification catalogs. To formulate and adjust the classification catalog, the opinions of medical device manufacturers, users, and industry organizations should be fully listened to, and the practice of international medical device classification should be referred to. The classification catalog of medical devices shall be published to the public.
About Surgaid Medical：
Surgaid Medical (Xiamen) Co., Ltd has been committed to surgical product development ,production and marketing for 10 more years . In particular, minimally invasive surgical products. Minimally invasive surgery is a surgical direction of development. Such as Disposable Laparoscopic Trocar, Linear Cutter Stapler, Circular Stapler, PPH, and so on.
Manufacturing our own Surgical products allows us to have complete control over the design and evolution of our products. We are able to adapt quickly to the constantly evolving healthcare market and offer high quality, single-use, cost-effective solutions that directly compete with global market-leaders.
Surgaid products:
For more product information at https://www.surgaid-medical.com/