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What procedures are needed to open a second-class medical device sales store
Author: Anonymous Medical Devices: Site author Hits: Updated: 2019-12-24

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It is a second-class medical device with a medium risk. Medical devices that prove its safety and inefficiency need to be strictly controlled. Sets, thermometers, sphygmomanometers, oxygen generators, and nebulizers are like band-aids and contraception commonly used in our daily lives. The product and drug supervision department implements the license to handle its products and production activities by provincial food, and the "Medical Device Production License" is issued separately to the "Medical Device Registration Certificate." The drug supervision part implements the filing and handling of the operation. The municipal food with districts is set up.

All the materials can be prepared and registered quickly. I hope that the successful registration of the medical device is a necessary document for the medical industry. If it is necessary, it should be submitted! What's the reply? Comments received like it has been disliked

"Medical Device Operation Enterprise License" I. Medical Device Company Registration Companies that operate medical device products need to apply to the local Food and Drug Surveillance Bureau

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It is necessary to license medical devices for operating enterprises. The people's government (food) and drug monitoring and handling bureau is the national and county level or above. The license (opening the area may apply for a license first) can only be closed with an operating permit. The equipment is divided into three types of countries, which will be medical, to the classification of the catalog to be able to see. The products fall into several categories that you want to operate. It is the first type. If the license is not required, the license operation will be indirectly handled. It is necessary to apply for permits of Class II or above. (Registration certificate, registration form, production license) Three relevant certificates for medical devices need to be obtained from the relevant manufacturers. The Product Surveillance Bureau's Device Division and Marketing Division can indirectly consult local medicines.

Copies of property right certification documents or lease negotiations (with Hengyu property right certification documents) (5) Maps, floor plans, and location maps of Hengyu;

The storage premise that is commensurate with the scale of operation (3) has the same scope as the operation, and the enterprise can fully entrust other medical devices to operate without setting up a warehouse;

All documents and certificates of related appointment, election or employment (5) specify the names and residences of the company's directors, supervisors and managers;

Equipment does not require a license and records to operate the first-type medical devices. Devices are registered to operate the second-class medical devices. Devices are licensed to operate the third-class medical devices.

The first type of medical devices that can guarantee its safety and invalidity are medical devices with low risk and constant implementation. Beds, medical ice packs, cooling stickers, etc. are like scalpels, surgical scissors, and manuals. Produce and production activities by location. Then all operations are rolled out, and there is no need to save the case without permission. The suspension of business that is issued can be obtained only by the business sector.

It is a third type of medical device with high risk. It is necessary to adopt strict methods to control medical devices to ensure its safety and invalidity. Cardiac stent, ventilator, CT, MRI, etc. are like common infusion sets, needles, and veins. The indwelling needle, the product supervision part and the city food and drug supervision part of the district have implemented permits to handle the separation of their products and production operations. They are issued separately by the State General Administration, provincial food and medicine, and machinery production permits, and the Medical Device Operation Permit. "Medical Device Registration Certificate", "Medical Devices.

Ability to provide professional guidance, technical training, and after-sale services (5) If it is compatible with the medical equipment in operation, the organization provides technical support or agrees to be related.

The compliant quality management institution or quality management personnel (1) The quality management personnel who have relevant professional qualifications or professional titles recognized in accordance with the scope and scale of operations should have a nationality;

Photocopy of the responsible person's identity certificate, academic qualifications or professional title certificate (2) Legal representative, enterprise representative, and quality;

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