Criteria for Class I medical device inspection program?
In the international standard classification, a class of medical device testing involves medical equipment, laboratory medicine, disinfection and sterilization.
In China's standard classification, a class of medical device testing involves medical device synthesis, extracorporeal circulation, artificial organs, prosthetic devices, general and microsurgical instruments.
(1), YY/T1805.3-2022 Tissue-engineered medical device products collagen part 3: collagen content detection based on characteristic peptide determination - liquid chromatography-mass spectrometry
(2), YY/T1805.2-2021 Tissue-engineered medical devices Product collagen part 2: type I collagen molecular weight detection - sodium dodecyl sulfate polyacrylamide gel electrophoresis method
(3), YY/T1695-2020 human assisted reproduction technology medical devices culture fluid in the amino acid detection method
State Food and Drug Administration, on the detection of a class of medical devices standard
(4) ), YY/T1561-2017 Detection of residual α-Gal antigen in animal-derived scaffold materials for tissue engineering medical device products
Industry standard-pharmaceuticals, standard on the testing of class I medical devices
(5), YY/T1454-2016 Basic requirements for in vitro diagnostic medical devices for self-testing
(6), YY/ T0681.11-2014 sterile medical device packaging test methods Part 11: visual inspection of medical packaging seal integrity
(7), YY/T0681.5-2010 sterile medical device packaging test methods Part 5: internal pressure method to detect gross leakage (bubble method).
Can general trading companies sell medical masks?
First of all, you need to have the business scope of the business scope of selling masks, and then the import and export business rights, and then is to apply for Class II medical device license. For the second class medical device license need enterprise digital certificate, a copy of the business license and legal person's ID card copy and phone number, the second class medical device license cost is about 1000 yuan. If you are exporting to the United States and the European Union, you need FDA U.S. medical record, CE EU medical record.