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 Pathway | Product | Manufacturer |
| Prioritized Review and Approval of Medical Devices | Photosensitive zirconia ceramic material for dental crown | Kunshan Porimy |
| Prioritized Review and Approval of Medical Devices | Measurement Software for Quantitative Intravascular Fractional Flow | Pulse Medical Imaging Technology (Shanghai) CO.LTD |
| Special Review Procedure for Innovative Medical Devices | Magnetic Resonance Imaging System | Xingaoyi Medical Equipment Co.,Ltd. |
| Special Review Procedure for Innovative Medical Devices | Electronic endoscopic image aided diagnostic software for lower digestive tract polyps | WuHan EndoAngel Medical Technology Co.,LTD |
| Special Review Procedure for Innovative Medical Devices | Proton Therapy System | Shanghai APACTRON Particle Equipment Co., Ltd |
| Special Review Procedure for Innovative Medical Devices | Module Embedded Aortic Arch Covered Stent System | DINOVA Med-Hangzhou Weiqiang |
| Special Review Procedure for Innovative Medical Devices | Aortic Covered Stent System | Lifetech Scientific |
By Jacky Li. Contact Cisema if you would like to learn more.
