On March 18, 2025, the Center for the Technical Review of Medical Devices of the State Drug Administration (CMDE) published the latest "Master File Registration Information Public Notice", which shows that Acres Bio's independently developed Pro Taq HS pre-mixed probe-based qPCR kit, one-step RT-PCR kit Successfully filed through the master file registry!
CMDE master file registration is an important system for the supervision of medical device raw materials, through the filing of raw material data can be directly referenced by downstream IVD enterprises, avoiding the duplication of submission and review of relevant technical information, optimizing the registration and reporting process, and significantly shortening the time to market.
After the completion of the filing of the two core reagent kits, the partner companies only need to obtain authorization (provide the product corresponding to the master file number), you can call the filing data with one key, to achieve the whole chain of ”raw material procurement - reagent production - registration and reporting”, to help partners to seize the golden window period of the market.