Ye County medical health group belongs to where the management

Medical devices belong to the management of health supervision. Local people's governments at or above the county level should strengthen the leadership of the supervision and management of medical devices in the administrative region, organize and coordinate the supervision and management of medical devices in the administrative region as well as the response to emergencies, strengthen the supervision and management of medical devices and capacity building for medical device safety work to provide security.

I. Engaged in the production of medical devices, should have the following conditions

(a) with the production of medical devices and production sites, environmental conditions, production equipment and professional and technical personnel;

(b) the production of medical devices to carry out quality inspection of the institution or full-time inspectors and inspection equipment;

(c) to ensure the quality of medical devices Management system;

(D) with the production of medical devices compatible with the after-sales service capabilities;

(E) in line with the product development, production process documentation requirements.

II. Record matters include:

(a) the name, model, specifications, quantity of medical devices;

(b) the production lot number of medical devices, the use of the period or expiration date, the date of sale;

(c) the name of the registrant of the medical device, the filing of the name of the registrar and commissioned production enterprises;

(d) the name of the supplier or buyer, address and Contact information;

(E) the number of relevant licensing documents.

Three. Class I medical device products for the record and apply for Class II, Class III medical device product registration, the following information should be submitted:

(a) product risk analysis information;

(b) product technical requirements;

(c) product inspection reports;

(d) clinical evaluation information;

(e) product specifications and labeling samples

(F) and product development, production and quality management system documents;

(G) to prove that the product is safe, effective and other information required.

Legal basis:

"Regulations for the Supervision and Administration of Medical Devices"

Article 1

In order to ensure the safety and efficacy of medical devices, to protect human health and life safety, and to promote the development of the medical device industry, the enactment of these regulations.

Article 2

These regulations shall apply to the development, production, operation and use of medical devices and their supervision and management within the territory of the People's Republic of China*** and the People's Republic of China.

Article 3

The Drug Administration of the State Council is responsible for the supervision and management of medical devices throughout the country.