As a class III medical device, for the first time PGT-A kit has been enlisted for the national mandatory medical industry standards.
According to the announcement of the State Drug Administration, seven IVD related industry standards will be implemented beginning from August 1st, 2020 (No. 60 in 2019). From October 1st, 2020, IVD related industry standards will be implemented (No. 84 of 2019).China will have enlisted PGT - A kit into as the class-III medical device regulation.
Class 3 represents those devices with the highest amount of risk in their use, these must be properly and rigorously examined by the FDA. It refers to the medical devices implanted into the human body to support and maintain life, which could have potential risks to the human body, safety and effectiveness must be strictly controlled.
According to the compulsory provisions of relevant national medical device laws, any medical institution (including hospitals, medical laboratories, medical test centers, etc.) shall use medical devices with registered certifications. When carrying out clinical application projects, and the platform used for the product development and must be able to obtain class-III medical device registration certificate.
In February 2014, the State Food and Drug Administration and the Health Commission jointly issued a notice on strengthening the management of products and technologies related to gene sequencing in clinical use, which made it clear that gene sequencing diagnostic products belong to medical devices, and required them to apply for product registration according to regulations, and stressed that "medical devices are not registered shall not be produced, import, sell or use". The notice clearly requires that products; such as: detection instruments, diagnostic reagents and relevant medical software needed for gene sequencing should be approved and registered by the food and drug regulatory department and approved by the health and family planning administrative department.