Submit the application form for the production license of veterinary medical devices; provide the geographic location of the production site, the layout plan and the layout of the functional areas; provide documents proving the right of use of the production site; submit the legal representative or person in charge of the identity card; provide the original and a copy of the certificate of veterinary surgeon; provide the facilities and equipment Inventory; submit the text of the management system; provide health certificates of licensed veterinarians and service personnel.
Veterinary medical devices classification standards:
1, according to the risk level: veterinary medical devices are usually divided into three categories according to the degree of risk, the first category of the lowest risk, the third category of the highest risk;
2, according to the use of objects: divided into medical devices specifically for a certain animal, such as dogs, cats, or general-purpose medical devices for a variety of animals;
3, according to the use of parts: such as external, internal, in vitro diagnostic devices, etc.;
4, according to the principle of action: divided into physical, chemical, biological and other different principles of medical devices;
5, according to whether it is a one-time use: divided into disposable medical devices and reusable medical devices.
In summary, for veterinary medical device production license need to submit an application form, the layout of the premises and the right to use the certificate, the legal representative or person in charge of the identity card, veterinary qualification certificates and photocopies, the list of facilities and equipment, the text of the management system, as well as the veterinarians and service personnel's health certification materials.
Legal basis:
"Regulations for the Supervision and Administration of Medical Devices"
Article 30
Engaged in the production of medical devices, shall have the following conditions: (a) with the production of medical devices and the production of suitable production sites, environmental conditions, production equipment, and professional and technical personnel; (b) there are capable of the production of medical devices for quality inspection of the organization (B) the production of medical devices to carry out quality inspection of the organization or full-time inspectors and inspection equipment; (C) to ensure that 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.