PGT-A kits are the first to be included in the national mandatory pharmaceutical industry standards as Class III medical devices.

PGT-A kits are included in the mandatory pharmaceutical industry standardS The State Drug Administration issued a document to further strengthen the management of mandatory industry standards for medical devices Recently, the State Drug Administration, in accordance with the Standardization Law of the People's Republic of China, the Regulations on the Supervision and Administration of Medical Devices, the Mandatory National Standards Management Measures and the Measures for the Administration of Medical Device Standards, issued a statement saying that it will focus on effectively maintaining the legal status of the mandatory industry standards from 12Further improve the mandatory industry standard system 3Improve the drafting and implementation of mandatory industry standards 4Strengthen mandatory industry standards of the public training 5Standardize the implementation of mandatory industry standards 6Strengthen the implementation and evaluation of mandatory industry standards these six aspects, further unify the understanding of mandatory industry standards, and effectively promote the mandatory industry standards for medical devices norms, effective implementationArticle 6 of the Regulations on the Supervision and Administration of Medical Devices,, stipulates that "medical device products shall comply with mandatory national standards for medical devices; "All relevant units should fully understand the legal status of mandatory industry standards, effectively safeguard the authority of mandatory industry standards, and ensure the effective implementation of mandatory industry standards."The state will be PGT-A kit into Class III medical device supervision Class III medical device is the highest level of medical devices, but also must strictly control the medical device, refers to implanted in the human body, to support, maintain life, potential lying to the human body, its safety, effectiveness must be strictly controlledPGT-A kits belong to Class III medical devices, in accordance with the mandatory provisions of the relevant laws on national medical devices, any medical institutions (including hospitals, medical testing institutes, medical testing centers, etc.) in the development of clinical applications, should use a registered medical device, product development on the platform must also obtain three types of medical device registration certificateIn February 2014, the State Drug Administration and the Health and Care Commission jointly issued the Notice on Strengthening the Management of Products and Technologies Related to The Clinical Use of Gene Sequencing, which clarified that gene sequencing diagnostic products are medical devices and required them to apply for product registration in accordance with the regulations, stressing that "medical device products that are not approved for registration shall not be produced, imported, sold or used"The notice also clearly requires that genetic sequencing needs to be applied testing instruments, diagnostic reagents and related medical software and other products, need to be approved and registered by the food and drug regulatory authorities, and approved by the health and family planning administrative departments of technical accessThe first three-generation test tube PGT-A kit approved for listing According to the official website of the State Drug Administration, the public notice shows that the current domestic PGT-A kit has been approved for listingIn February this year, Suzhou Beikang Medical Devices Co., Ltddeveloped the PGT-A three-generation test ingeuch test kit has been recognized at the national regulatory level, obtained the listing approval (National Firearms Injection: 20203400181)The kit is the first approved PGT-A testing products in China, filling the technical gap in China's three-generation test tube application, marking the three generations of test tube PGT-A testing officially entered the era of certification, but also to make up for the domestic non-legitimate three-generation test tube productsClinical trial data show that PGT-A products were able to increase the average pregnancy rate of IVF to 72% and the average abortion rate to 6.9%