Recently, the Linyi County Maternal and Child Health Station in Hebei Province received an administrative penalty of 17.654 million yuan for using unregistered medical equipment, which sounded the alarm for other medical institutions. The huge ticket to the maternal and child health hospital not only sounded the alarm of the medical institution norm, but also sounded the third-party medical test, especially the alarm of the genetic testing industry. It has a great influence on the genetic testing instruments, reagents and testing services. As an emerging medical diagnostic science, there are still many irregularities in its own, but the state's supervision has undoubtedly accelerated the tightening. Prenatal screening does not eat roadside booth sampling agency qualifications have provisions In December 2016, a staff member of Jinhua Biotechnology Co., Ltd. collected blood samples for pregnant women at the entrance of a hospital in Dongyang City to carry out prenatal screening of fetal free DNA in pregnant women. According to the investigation by the supervisor of the Dongyang Health Supervision Institute, the company did not comply with the document issued by the Health Planning Commission on November 9th, the National Health and Welfare Office [2016] No. 45, “The Office of the National Health and Family Planning Commission, on the regular and orderly implementation of pregnant women’s periphery. Relevant provisions in the Notice of Prenatal Screening and Diagnosis of Blood Fetal Free DNA. According to relevant laws, the company has been filed for investigation. The Notice clearly stipulates that medical institutions that conduct prenatal screening and diagnosis of blood collection services for pregnant women with peripheral blood of pregnant women should be qualified prenatal screening or prenatal diagnostic institutions, and tighten institutions that have not previously had prenatal qualifications or The sampling and sampling of county-level hospitals, institutions with prenatal diagnostic qualifications will become the only sampling channel.
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Analysis of the impact of the 17.65 million large ticket on the medical device industry