Selling medical equipment qualification requirements depends on which category you are: Class III medical devices need to obtain business license strong>, Class II only need to operate for the record, a class of what is not needed.
Sale of medical equipment qualification specific requirements:
Business license or record vouchers are in the provincial government service centers for processing, licensing and filing of the difference is that the three types of permits are required to go on-site inspection, specifically to see whether your facilities and equipment, personnel site to meet the licensing requirements, the two types of filing is only to provide information and commitment to meet the conditions, and then the record. Issuance of filing vouchers and then post-filing review.
Hardware facilities, operating temperature control requirements of the product requirements are relatively high, such as part of the requirements of the entire cold chain of in vitro diagnostic reagents, the need to operate the enterprise to build their own cold storage.
At present, buying and selling medical devices on the Internet is required to obtain the Internet trading record, the general principle is that the online and offline conditions are consistent, that is, offline to have an entity, and obtain the appropriate business license or record.
Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly in the human body, including the required computer software.
Medical devices include medical equipment and medical consumables.
Utility is obtained primarily by physical and other means, not by pharmacological, immunological or metabolic means, or is involved but only in an ancillary manner.
The purpose is the diagnosis, prevention, monitoring, treatment or alleviation of disease; the diagnosis, monitoring, treatment, alleviation or functional compensation of injury; the examination, substitution, regulation or support of physiological structures or processes; the support or maintenance of life; the control of pregnancy; and the provision of information for medical or diagnostic purposes through the examination of specimens derived from the human body.
Refer to Baidu Encyclopedia - Medical Devices for the above