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NMPA Announcement on the Issuance of 13 Guidelines for Technical Review of the Registration of Augmented Extremity Compression Therapy Equipment and Others

Updated: 2019-11-15

To strengthen the supervision and guidance over the registration of medical device products and further improve the quality of registration review, NMPA has organized the formulation of and released on November 15, 2019 the Guidelines for Technical Review of the Registration of Augmented Extremity Compression Therapy Equipment, Guidelines for Technical Review of the Registration of Medical Device Products Under Benefits-Risk Assessment, Guidelines for Technical Review of the Registration of Direct Ophthalmoscopes, Guidelines for Technical Review of the Registration of Medical Diagnostic X-Ray Tube Assembly, Guidelines for Technical Review of the Registration of Electromyographic Biofeedback Therapy Device, Guidelines for Technical Review of the Registration of Surgery Drills for Dental Implant, Guidelines for Technical Review of the Registration of Artificial Resuscitators, Guidelines for Technical Review of the Registration of Active and Passive Rehabilitation Training Equipment for Upper and Lower Limbs, Guidelines for Technical Review of the Registration of Single-use Endoscopic Biopsy Forceps, Guidelines for Technical Review of the Registration of Plasma Quick Freezer, Guidelines for Technical Review of the Registration of Enteral Feeding Pump, Guidelines for Technical Review of the Registration of Apex Locator, and the Guidelines for Technical Review of the Registration of Urodynamic Analyzer.