NMPA published eighteen industry recommended standards on July 6, 2022 to guide manufacturers for local type testing and regulatory approval:

• YY/T 0273-2022 Dentistry-Dental amalgam blender
• YY/T 0290.4-2022 Ophthalmic optics – Intraocular lenses – Part 4: Labeling and information
• YY/T 0299-2022 Medical ultrasonic couplant
• YY/T 0482-2022 Medical Magnetic Resonance Imaging Equipment-Determination of Main Image Quality Parameters
• YY/T 0519-2022 Dentistry-Testing of bonding with tooth structure
• YY/T 0612-2022 Disposable human arterial blood sample collector (arterial blood gas needle)
• YY/T 0634-2022 Ophthalmic instruments Fundus camera
• YY/T 0793.1-2022 Preparation and quality management of fluids for hemodialysis and related treatments – Part 1: Water treatment equipment for hemodialysis and related treatments
• YY/T 0793.4-2022 Preparation and quality management of fluids for hemodialysis and related treatments – Part 4: Dialysate quality for hemodialysis and related treatments
• YY/T 0821-2022 Disposable Dispensing Syringes
• YY/T 1789.3-2022 In vitro diagnostic test system-performance evaluation method-Part 3: detection limit and quantification limit
• YY/T 1789.4-2022 In-vitro diagnostic test system-performance evaluation method-Part 4: Linear interval and reportable interval
• YY/T 1810-2022 Tissue engineering medical products Quantitative detection of sulfated glycosaminoglycans (sGAG) for evaluating cartilage formation
• YY/T 1833.1-2022 Artificial Intelligence Medical Devices-Quality Requirements and Evaluation Part 1: Terminology
• YY/T 1833.2-2022 Artificial Intelligence Medical Devices-Quality Requirements and Evaluation-Part 2: General Requirements for Data Sets
• YY/T 1835-2022 Performance and test methods of breast positron emission tomography devices
• YY/T 1845-2022 General requirements for surgical guides for orthopedic surgery
• YY/T 1848-2022 Disposable ureteral occlusion catheter

The industry recommended standards are not legally binding but recommended by regulatory authorities. For English version of any standards above, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.