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On January 17, the State Food and Drug Administration issued 6 guidelines for medical device registration review, involving disposable high-pressure imaging syringes and accessories, degradable magnesium metal orthopedic implants, intraocular lenses,
etc.
The details are as follows: Notice of the State Food and Drug Administration on Issuing 6 Guidelines for Registration Review of Disposable High-Pressure Contrast Syringe and Accessory Products (No.
4 of 2022) In order to strengthen the supervision and guidance of medical device product registration, and further improve registration review Quality, the State Drug Administration organized and formulated the "Guidelines for the Registration and Review of Disposable High-Pressure Angiography Syringes and Accessories", "Guidelines for the Registration and Review of Metal Bone Plate Internal Fixation System Products (Revised in 2021)", "Degradable Magnesium Metal Orthopaedic Implants" The Guidelines for Registration and Review of Entry, the Guidelines for Registration and Review of Microcatheter, the Guidelines for Registration and Review of Disposable Endoscopic Injection Needles, and the Guidelines for Registration and Review of Intraocular Lenses are hereby issued
.
Attachments: 1.
Guidelines for the registration review of disposable high-pressure angiography syringes and accessories 2.
Guidelines for the registration review of metal bone plate internal fixation system products (revised in 2021) 3.
Guidelines for the registration review of degradable magnesium metal orthopaedic implants 4 .
Guidelines for registration review of microcatheter 5.
Guidelines for registration review of disposable endoscopic injection needles 6.
Guidelines for registration review of intraocular lens