1, medical device business, refers to the purchase and sale of medical equipment products to provide the behavior of the purchase and sale of medical equipment products, including procurement, acceptance, storage, sales, transportation, after-sales service.
2, medical device wholesale, refers to the sale of medical devices to qualified business enterprises or the use of medical equipment business behavior.
3, medical device retail, refers to the medical device sales directly to consumers of medical equipment business behavior.
"Supervision and Administration of Medical Devices" is to strengthen the supervision and management of medical devices, standardize the operation of medical devices, to ensure the safety and efficacy of medical devices, according to the "supervision and management of medical devices regulations".
Medical device registrant, filer or manufacturer of medical devices in its residence or production address sales of medical devices, do not need to apply for business licensing or filing; in other places of storage and spot sales of medical devices, should be in accordance with the provisions of the business license or filing.
Expanded
Medical device business enterprise for its office or sales personnel in the name of the enterprise engaged in the purchase and sale of medical devices bear legal responsibility. Medical device business enterprise sales personnel sales of medical devices, should provide the official seal stamped with the authorization of the enterprise. The authorization shall contain the authorized sales of varieties, geographic area, period, indicating the salesperson's identity card number.
Enterprises engaged in the wholesale business of medical devices, its purchase, storage, sales and other records should meet the requirements of traceability. Purchase inspection records and sales records should be kept until 2 years after the expiration date of the medical device; no expiration date, not less than 5 years. Implantable medical devices purchase inspection records and sales records should be kept permanently. Encourage other medical device business enterprises to establish sales record system.
Baidu Encyclopedia - Medical Device Business Supervision and Management Measures