Illumaxbio received a notice from the CMDE (Center For Medical Device Evaluation) of Sichuan Medical Prouducts Administration on November 11th, agreeing that the Automatic Multiplex Immunoassay System of Illumaxbio can be reviewed in accordance with the special review procedure for in vitro diagnostics (IVD). It is reported that Illumaxbio is the first IVD company in Sichuan province to enter the special review procedure for medical devices in 2021. The worldwide first single automatic multiplex Immunoassay System that is launched by Illumaxbio, with ingenious design for clinical needs, breaking through the technological blockade of many core components, and the whole chain is independent and controllable.
Inclusion in the list of national innovative medical devices is highly demanding, with an approval rate of just 5.2% in 2021. Requirements are as follows:
·Patented – The applicant has the patent right or the right to use the core technology of the product in China according to law
·Innovation – the main working principle of the product is initiative domestically by the applicant , and the technology belongs to the international leading level, which has obvious clinical value.
·Product – The product has been basically finalized. The research process is truly controlled, and the research data is completely traceable.
The special approval procedure is the fast track for medical devices; The National Medical Products Administration will give priority to review and approval on the premise that standards are not lowered and procedures are not reduced. According to the statistics of the National Medical Products Administration (NMPA), the product that enters into the special approval procedure obtains the registration certificate of NMPA 83 days earlier than other similar products, which is significantly shorten the certification cycle and increase the competitiveness. The earlier the registration certificate get, the better chance to capture market share.
Post time: Sep-07-2021