How to apply for a Shenzhen medical device business license

Medical devices are divided into three categories，One type can be operated directly without applying for a license.，Category II requires registration and can be operated，The third category is relatively troublesome，You must obtain a medical device business license before you can operate，Let’s first talk about which medical products need to apply for a license：For implantation into the human body or to support life-sustaining，Potentially dangerous to human body，to its security、Medical devices whose effectiveness must be strictly controlled。

such as implantable pacemaker、extracorporeal shock wave lithotripsy、Patient Invasive Monitoring System、intraocular lens、Invasive endoscopy、ultrasonic scalpel、Color ultrasound imaging equipment、laser surgery equipment、High frequency electrosurgery、Microwave therapy device、Medical MRI equipment、X-ray therapy equipment、200X-ray machine above mA、Medical high energy equipment、artificial heart-lung machine、Internal fixation equipment、artificial heart valve、artificial kidney、respiratory anesthesia equipment、Disposable sterile syringe、Disposable infusion set、blood transfusion set、CT equipment, etc.。

So what are the specific conditions to apply for a medical device license?：First 1、Have a quality management organization or full-time quality management personnel that is suitable for the business scale and scope of business。

Quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state；

1. Have a relatively independent business location that is commensurate with the business scale and scope of business；
2. Have storage conditions suitable for the business scale and business scope，Including products that comply with the characteristics of medical devices

Require

storage facilities、equipment；

1. A sound product quality management system should be established，including procurement、Incoming goods acceptance、Warehousing and storage、Warehouse review、Quality tracking system and adverse event reporting system, etc.；
2. Should have technical training and after-sales service capabilities suitable for the medical device products it operates.，Or agree to have a third party provide technical support。

If anyone needs to apply for a medical device business license in Shenzhen, you can contact me for free consultation.，The company not only provides agency services，There are also ready-made license plates available for transfer，Over the years, we have helped nearly a hundred companies obtain corresponding licenses.，I believe we can also provide you with a satisfactory service。

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