What are the standards of the Drug Administration on the layout of medical device companies

Reference to the "Code for the Quality Management of Medical Device Manufacturing"

Chapter III Plant and Facilities

Article XII of the plant and facilities should be in line with the production requirements, production, administrative and auxiliary areas of the overall layout should be reasonable, and shall not interfere with each other.

Article XIII of the plant and facilities should be based on the characteristics of the products produced, the process and the corresponding clean level requirements for rational design, layout and use. Production environment should be clean, in line with product quality needs and relevant technical standards. Products have special requirements, should ensure that the external environment of the plant can not have an impact on product quality, if necessary, should be verified.

Article XIV of the plant should ensure that the production and storage of product quality and related equipment performance will not be directly or indirectly affected, the plant should have appropriate lighting, temperature, humidity and ventilation control conditions.

Article XV of the design and installation of plant and facilities should be based on product characteristics to take the necessary measures to effectively prevent insects or other animals from entering. Maintenance and repair of plant and facilities shall not affect product quality.

Article XVI of the production area should have enough space, and the scale of production of its products, varieties appropriate.

Article XVII of the storage area should be able to meet the raw materials, packaging materials, intermediate products, products and other storage conditions and requirements, in accordance with the pending inspection, qualified, unqualified, returned or recalled, etc., partitioned storage, easy to check and monitor.

Article XVIII of the enterprise should be equipped with product production scale, variety, inspection requirements are appropriate for the inspection site and facilities.