Guideline and Standard Update for Medical Devices & IVDs in January and February 2021

China Regulatory Guidelines Issued / Updated

The NMPA (National Medical Products Administration) issued regulatory guidelines for 5 medical devices (including IVDs) throughout January and February 2021:

• Technical Guidelines for Clinical Evaluation on Medical Magnetic Resonance Imaging System  (2020 amended version)
• Technical Guideline for Clinical Evaluation on Ultrasonic Imaging and Diagnostic Devices
• Technical Guideline for Clinical Evaluation on X-ray Computed Tomography Equipment
• Technical Guideline for Mycoplasma Pneumoniae IgM/IgG Antibody Test Reagents
• Technical Guideline for Cryptococcus Capsular Polysaccharide Antigen Test Reagents
• Technical Guideline for Gene Mutation Reagents for Genetic Deafness

The NIFDC announced to solicit public comments for the implementation of GB and YY standards for the following 4 medical electrical equipment in January and February 2021:

• YY/T standard to replace YY 91064-1999 for Dental rotary instruments-Drill used in Dental Implant Placement and Treatment
• GB standard for medical electrical equipment – Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment
• GB standard for medical electrical equipment – Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
• GB standard for medical electrical equipment – Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

Fast-Track Approval Updates

The NMPA granted the fast-track approval for the product registration of Lifetech Scientific’s iliac artery bifurcation stent system and Hunan Apt Med’s anchor balloon catheter via the Procedure for Prioritized Review and Approval of Medical Devices.

The NMPA also approved the application of the following products to enter the fast-track approval pathway. All the manufacturers are Chinese companies.

Fast-Track Approval PathwayProductManufacturerPrioritized Review and Approval of Medical DevicesPhotosensitive zirconia ceramic material for dental crownKunshan PorimyPrioritized Review and Approval of Medical DevicesMeasurement Software for Quantitative Intravascular Fractional FlowPulse Medical Imaging Technology (Shanghai) CO.LTDSpecial Review Procedure for Innovative Medical DevicesMagnetic Resonance Imaging SystemXingaoyi Medical Equipment Co.,Ltd.Special Review Procedure for Innovative Medical DevicesElectronic endoscopic image aided diagnostic software for lower digestive tract polypsWuHan EndoAngel Medical Technology Co.,LTDSpecial Review Procedure for Innovative Medical DevicesProton Therapy SystemShanghai APACTRON Particle Equipment Co., LtdSpecial Review Procedure for Innovative Medical DevicesModule Embedded Aortic Arch Covered Stent SystemDINOVA Med-Hangzhou WeiqiangSpecial Review Procedure for Innovative Medical DevicesAortic Covered Stent SystemLifetech Scientific

By Jacky Li. Contact Cisema if you would like to learn more.