Outstanding domestic medical equipment, the fourth batch of selection began

Pharmaceutical Network November 15 hearing November 14, China Medical Equipment Association issued a public notice to select the first batch of 4 outstanding domestic medical equipment, which for the domestic medical equipment, but also a good day.

Multi-parameter monitor

Portable color Doppler ultrasound diagnostic apparatus

3.0T magnetic resonance

Mobile digital X-ray machine

Microbial Identification and Drug Sensitive System

Blood coagulation instrument

Extracorporeal shock wave therapy device

Endoscopic cutting stapler

Laser treatment instrument

Photon therapy device

Artificial joints

Orthopedic spine material

Primary inspection overall solution

At the same time, it will dynamically adjust the digital X-ray machine, desktop color Doppler ultrasound diagnostic apparatus, automatic biochemical analyzer three products.

The Institute said the selected products need to meet the needs of clinical work, to ensure medical safety, excellent performance, recognized by medical institutions, production and operation of enterprises have a good reputation, and complete after-sales service system and quality standards and norms.

The catalog of excellent domestic medical equipment shall be valid for three years in a single batch. After expiration, it shall carry out the selection and review, submit the product registration certificate, fill in the product declaration form, and review and pass it into the Catalog of Outstanding Domestic Medical Equipment.

Under any of the following circumstances, no application for review may be made:

1) Products that have been phased out and are to be phased out, including enterprises that are 'Bao Bo' without production;

2) product design, structure, performance has lagged behind, the style is old;

3) In the past two years, medical malpractice or use units product quality Strongly reflected;

4) Within the validity period, there are more than two times of unqualified (including twice) in spot checks and routine inspections by the State Food and Drug Administration.

In the selection standard On the main technical parameters, enterprise Basic conditions and clinical application of three parts.Entry into the excellent medical equipment product catalog standards for the technical parameters, clinical evaluation, the basic situation of the enterprise are not less than 80% of such scores.

Among them, the main components of the device's technical parameters, advanced technology, performance and clinical requirements, software, detailed evaluation.

The basic situation of the enterprise is mainly to make a comprehensive evaluation on the scale, financial status and after-sales service stations and points of the company.

Clinical evaluation mainly from the clinical application of safety, effectiveness, convenience, failure rate, service life and adverse events and other aspects of the quantitative score by the clinical application of expert on-site evaluation and third-party telephone follow-up of two parts.

Information about the selection process, etc., can be concerned about the Chinese medical equipment network, the selection activity does not charge fees to businesses in any name.