POCT national regulatory norms

Legal analysis: POCT is a new mode of development of laboratory medicine, new fields, its rapid development thanks to the development of today's high-tech and integrated application, but also in line with the current efficient and fast-paced mode of operation of the community, to meet the physician and the patient's needs in time, which allows patients to get diagnosed and treated as soon as possible, but also to the traditional model of health care has brought opportunities. POCT with portable instruments and reagents to report results within a few minutes can bring convenience for patients to timely diagnosis and treatment. POCT with portable instruments and reagents in a few minutes to report the results, can be timely diagnosis and treatment for patients to bring convenience, by virtue of its experimental technology miniaturization, easy to operate, the test results of the immediate report, etc., favored by doctors and patients, the current in the test of medicine appeared in the large-scale automated instruments and small POCT poles of development of the new trend.

Legal basis: "Chinese People's *** and State Regulations on the Administration of Medical Institutions" Article 16 Application for registration of medical institutions shall have the following conditions: (a) have set up a medical institution approval; (b) in line with the basic standards of the medical institutions; (c) have the appropriate name, organization and premises; (d) have its business to carry out the appropriate funding, facilities, equipment and professional and technical personnel; (e) have the appropriate name, organization and premises; (f) have its business to carry out the funds, facilities, equipment and professional and technical staff. (E) have the appropriate rules and regulations; (F) can independently assume civil liability.