Medical equipment company operating range
Medical equipment company operating range 43 major items:
"Medical device classification directory" description
1.6801 basic surgical instruments
Microsurgical instruments
Surgical Instruments
Eye Surgery Instruments
5.6805 ENT surgical instruments
6.6806 Stomatology surgical instruments
7.6807 Thoracic Cardiovascular Surgical Instruments
8.6808 Abdominal Surgical Instruments
9.6809 Urinary anorectal surgery
Orthopedic surgery (orthopedic) surgical instruments
Surgical Instruments for Obstetrics and Gynecology
12.6813 Family planning surgical instruments
13.6815 injection puncture device
14.6816 Burns (Surgery) Surgery Instruments
15.6820 General examination equipment
Medical electronic equipment and equipment
Medical optics, instruments and endoscopic equipment
Medical ultrasound equipment and related equipment
Medical laser equipment
Medical high - frequency equipment
Physical therapy and rehabilitation equipment
22.6827 Chinese medicine equipment
Medical magnetic resonance equipment
Medical X - ray equipment
Medical X - ray ancillary equipment and components
Medical high - energy radiation equipment
Medical radionuclide equipment
286834 Medical radiographic protective equipment, devices
Clinical examination and analysis equipment
Medical laboratory and basic equipment
Cardiopulmonary Bypass and Blood Treatment Equipment
32.6846 Implanted materials and artificial organs
33.6854 operating room, emergency room, treatment room equipment and apparatus
Stomatology equipment and apparatus
35.6856 Ward care equipment and apparatus
Disinfection and sterilization equipment and apparatus
Medical cold therapy, low temperature, refrigeration equipment and equipment
38.6863 Stomatological Materials
Medical hygiene materials and dressings
Medical suture materials and adhesives
Medical polymer materials and products
42.6870 software
43.6877 Intervention equipment
Business scope is the business scope of business activities, should be approved within the scope of business activities. According to the provisions of the State Administration for Industry and Commerce, "the scope of business registration management," the provisions of the company's scope of business should refer to the national economic industry classification standards and the relevant provisions. 4, apply for general business projects, the applicant should refer to the "national economic industry classification" and the relevant provisions of the choice of one or more types of business, according to the law directly to the enterprise registration authority for registration. The business scope of the business scope of the business should be consistent with the industry name of the enterprise name. The business scope of the enterprise shall be registered by the enterprise registration authority according to the application of the investor or the enterprise. The scope of business shall be consistent with the provisions of the articles of association or the partnership agreement. The applicant shall apply to the examination and approval authority in accordance with the laws, administrative regulations and the State Council, and upon application, it shall apply to the enterprise registration authority for approval through the approval documents and documents. The enterprise registration authority shall, in accordance with the approval documents, documents and registration of the examination and approval authority, operate the project.
Medical equipment company business scope in two cases:
One is the medical device manufacturing enterprises, its business scope is the enterprise has been registered license and production license products.
The other is specialized in the operation of medical equipment business.They are required to obtain the scope of business license or permit.If you are operating only a class of medical equipment, you do not need to record or permit.If you are operating two types of medical equipment, The Bureau of the Bureau of the record, through the latter can operate two types of medical equipment.Three types of medical equipment are required to get the local Provincial Food and Drug Administration permission, and should apply for the corresponding business license to operate three types of medical equipment.
So that the operation of medical equipment also determines the scope of your business.Other key point is that the medical equipment must be operated with the relevant production license and registration certificate can be carried out. Purely operating enterprises should provide suppliers to provide Corresponding information.
For details, please refer to the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision and Management of Medical Devices, both of which can be obtained from the website of the State Food and Drug Administration.