Article Source: Clinical Molecular Testing, IVD Practitioners Network
Recently, the wechat public account of Clinical Molecular Testing released an article titled "List of Nucleic Acid Testing project That Can Be Directly Filed in Shanghai", which mentioned that the official directory list of restricted medical technologies for nucleic acid testing in Shanghai has been updated again recently, with a total of 6 new project added this time.
After this addition, the number of nucleic acid testing project included in the restricted technology directory of Shanghai has reached 112. If the list of 8 gene chip diagnostic technology testing project is included, the number of molecular diagnostic project or technologies that can be directly filed for record in Shanghai has reached 120.
According to the requirements, if clinical laboratories in the Shanghai area plan to carry out relevant project listed in the directory, they only need to file with the health supervision department and do not need to be evaluated by a third-party institution. For molecular testing project not on this list, if they are to be carried out in Shanghai, they need to be evaluated by a third-party institution, that is, the Shanghai Clinical Laboratory Center, on the relevant new technologies. Only after the assessment is passed can they be included in this list and be normally filed and carried out.
