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What Are the Requirements for the Surgical Mask Operating Place and Warehouse Area?

There are five requirements for the business premises and warehouse area of surgical masks:

  1. For the operation of the Class II and Class III medical devices products, the use area of the business premises should not be less than 40 square meters, and the use area of the business premises of the branches of legal entities should not be less than 25 square meters (except for cross-districted cities) ; For hearing aids, the operating area should be no less than 25 square meters; for contact lenses and nursing fluids, the operating area should be no less than 10 square meters.

  1. Those dealing in Class II and Class III medical devices (except hearing aids, contact lenses and nursing fluids, in vitro diagnostic reagents for single-use sterile medical device products, 6846 implant materials and artificial organs, 6877 interventional devices), the usable area of warehouses should be no less than 30 square meters; the warehouses for single-use sterile medical devices, such as surgical mask machines, should be in the same building, and the usable area should be no less than 200 square meters.

  1. Branches of legal entities (except those established across districts and cities) and specialized medical equipment and equipment such as medical mask machines do not need to set up separate warehouses, but they should have a legal entity or authorized product manufacturer (including import general agent) and commitments related to unified procurement and distribution, unified quality management, installation and after-sales service with the original seal, as well as the registration certificate and authorization documents of the franchised products.

  1. Those dealing in hearing aids or contact lenses and their nursing fluids may not have a warehouse, but there should be special counters for storage.

  1. In principle, the declared business premises and warehouses shall be set up nearby within the same administrative area, and they shall not be located in residential, military, public security or armed police camps.

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