Only need to ensure that the enterprise is equipped with production equipment, process equipment, etc. that matches the products and scale of production, and ensure effective operation. Specifically, against the production process flow chart, check the list of equipment and process equipment, the equipment listed should meet the production needs, that is, with the production of medical devices related to all parts or components, semi-finished products, finished products are equipped with production equipment, process equipment. The need for outsourcing, outsourcing or commissioned processing should be in line with the provisions. Production equipment and process equipment processing technology, process parameters, processing accuracy should be suitable and meet the production of medical devices parts or components, semi-finished products, finished products, the quality of performance requirements.