Medical network November 15th hearing November 14th, China Medical Equipment Association issued a notice, to select the fourth batch of excellent domestic medical equipment, which is for domestic medical equipment, is a big positive.
It is understood that there are 13 items in this selection, including:
vital signs monitor
Portable color Doppler ultrasonic diagnostic instrument
3.0T magnetic resonance
Mobile digital X-ray machine
Microbial culture, identification and drug sensitivity system
Blood coagulation instrument
Extracorporeal shock wave therapeutic apparatus
Endoscopic stapler
Laser treatment instrument
Photon therapeutic apparatus
Artificial joint
Spinal materials in Department of orthopedics
Overall solution for grassroots inspection
At the same time, we will dynamically adjust digital X-ray machine, desktop color Doppler ultrasound diagnostic instrument, automatic biochemical analyzer three products.
The Institute said that the selected products need to meet the needs of clinical work, ensure medical safety, good performance, medical institutions recognized, production and operation enterprises have a good reputation, complete after-sales service system and quality standards and specifications.
The list of excellent domestic medical equipment products is valid for three years in a single batch. After expiration, it is necessary to conduct a selection review, submit the product registration certificate and fill out the product declaration form. After the review, the product catalogue of excellent domestic medical equipment is put into effect.
In case of any of the following circumstances, no reexamination shall be applied:
1) obsolete and ready to be eliminated products, including enterprises for "brand protection" but not production;
2) product design, structure, performance has been backward, the style has been obsolete;
3) medical accidents or units in use in the past two years strongly reflect the quality of the products;
4) within the period of validity, the national and local food and drug administration departments have two or more unqualified samples (including two times).
In the selection criteria, mainly by the technical parameters, the basic situation of the enterprise and clinical application evaluation of three parts. The technical standards, clinical application evaluation and the basic situation of the enterprise are not less than 80% of the full marks of the excellent medical equipment catalogue, which is included in the three parts.
Among them, the main components of the equipment technical parameters, key technology, advanced, performance and clinical requirements, software and other aspects of detailed evaluation.
The basic situation of the enterprise is mainly a comprehensive evaluation of the company's size, financial status and after-sales service stations, points and other aspects.
Clinical application evaluation mainly from clinical application safety, effectiveness, convenience, failure rate, after-sales service time and adverse events and other aspects of quantitative scoring, by clinical application experts on-site evaluation and third party telephone follow-up two parts.
Concerning the selection process and other information, attention should be paid to the China Medical equipment network, and the selection activities are not charged to enterprises in any name.
