Export epidemic prevention materials: temperature gun export declaration required information and process A full temperature gun product by the shell, internal circuit board, battery (system power) three parts, including LED display, infrared temperature sensor, battery, button, buzzer and so on。The temperature gun is actually a single-chip processing system, and the most important is the infrared temperature sensor module, which also determines the measurement accuracy。
The infrared sensor installed on the temperature gun is usually a thermopile sensor。Thermal sensors convert temperature differences and electrical energy into electricity。After feeling the heat radiation from the body surface, a weak potential signal is generated and transmitted to the MCU, and the temperature is displayed on the screen。Thermal guns have a medical rating of 0 per manufacturing specification.2 degrees, and the temperature gun used to measure human temperature must use 0.2 degree medical grade sensor chip。
At present, most of the main products of the temperature measuring gun are domestic, while the core infrared sensor is limited to imports。
Product code 9025199010(Infrared human thermometer) Temperature gun (infrared human thermometer), export tax refund 13%。
Qualifications of the manufacturer concerned。
Temperature gun manufacturing enterprises need to be produced in clean factories above 100,000 level, from purification production, clean installation to injection packaging sterilization, must strictly comply with national standards。
The temperature gun is the second type of medical device, according to the "Medical Device Classification Catalogue" issued in August 2017, approved by the provincial Food and Drug Administration of the manufacturer。Enterprises manufacturing this product, by the provincial food and drug supervision and administration department to implement licensing management, respectively issued medical device registration certificate "medical device production license"。According to the Metrology Law of the People's Republic of China, in order to ensure the accuracy and fairness of inspection data, quality inspection institutions that issue notarial inspection reports to the public must obtain metrology certification。To this end, it is necessary to apply for metrological certification to the Market Supervision Administration。
1.Provincial medical device inspection institutions entrust CNAS certification to carry out product inspection according to product technical requirements。
2.Prepare registration documents, combined with the company's actual production and model test report。The catalogue of exempt clinical products (latest number 353) is included in thermometers but requires an accurate validation report (GB/T21417-1:2008)
3.Complete registration documents, declare to the provincial food and Drug Administration, the provincial food and drug administration accepts。
4.The drug Administration accepts the registration documents simultaneously and sends the manufacturer to conduct on-site quality system review。
5.After obtaining the registration certificate, the manufacturer should prepare the application materials for the production license and apply for the production license to the Municipal Market Supervision Administration。
Temperature gun export declaration domestic export trade enterprises required materials
1.Business license (business scope includes relevant business content)
2.Enterprise production license
3.Product inspection report
4.Medical device registration certificate
5.Product description (product) and label (product tracking)
6.Product lot/lot number (packaged outside the product)
7.Product quality safety certificate or certificate (according to the product)
8.Product picture and outer packing picture
9.Chinese list
10.Chinese invoice
11.Chinese declaration form
12.Chinese contract
14.Certificate of origin
15.Medical materials export declaration