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CFDA: Record Number of Guidelines and Standards Issued in September


In the month of September, unprecedented number of medical device guidelines and industry standards issued by CFDA to expedite your registration and renewal.


CFDA issued 12 Technical Review Guidelines for 4 active devices, 4 non-active devices and 4 IVDs:

  • Active device: Technical Review Guideline on Medical Laser Fiber
  • Active device: Technical Review Guideline on Dual-energy X-ray Absorptiometry (DXA)
  • Active device: Technical Review Guideline on Ophthalmic High Frequency Ultrasound System
  • Active device: Technical Review Guideline on Active Device Shelf Life
  • Non-active device: Animal Test and Clinical Evaluation Guideline on Implantable Sacral Nerve Stimulation System
  • Non-active device: Quality Control and Clinical Evaluation Guideline of Spinal Implants
  • Non-active device: Technical Review Guideline on Puncture Needle Using Assisted Reproductive Technology (ART)
  • Non-active device: Technical Review Guideline on Embryo Transfer Catheter Using Assisted Reproductive Technology (ART)
  • IVD: Technical Review Guideline on Chlamydia Trachomatis and Neisseria Gonorrhoeae Reagent
  • IVD: Technical Review Guideline on Genetic Polymorphism Reagent of Drug-Metabolizing Enzyme CYP2C19
  • IVD: Technical Review Guideline on Amino Acid, Succinylacetone and Carnitine Detection Reagents
  • IVD: Technical Review Guideline on Respiratory Viral Panel Multiplex Nucleic Acid Assay


For official CFDA link of Industry Guidelines mentioned above, please email

China Med Device, LLC has onsite test engineers to help you assess and expedite your type testing needs to shorten your renewal or new approval time. For more information, please email


Industry Standard

CFDA issued 15 Industry Standards:

  • Industry Standard on Cardiopulmonary Bypass System: Damage Evaluation of Continuous Blood Flow Pump Red Blood Cell
  • Industry Standard on Dental Curing Light
  • Industry Standard on High Frequency Electrocautery Therapeutic Apparatus
  • Industry Standard on Infrared Treatment Equipment
  • Industry Standard on Carbon Dioxide Incubator
  • Industry Standard on Sterile Hypodermic Syringe
  • Industry Standard on Digital Photographic X-ray Machine
  • Industry Standard on Steam Generator
  • Industry Standard on Fatigue Test and Performance Requirements for Femoral Components
  • Industry Standard on Vertical Steam Sterilizer
  • Industry Standard on Quality Test for Medical Sterilization Steam
  • Industry Standard on Medical Device Irradiation Sterilization Process and Control Requirements
  • Industry Standard on Aperture of Rotary Dental Devices (Disc, Wheel, etc.)
  • Industry Standard on Blood Sample Collection Needle
  • Terminology for Dental Implant and Related Process

For official CFDA link of Industry Standards mentioned above, please email

CFDA announced “2018 Medical Device Industry Standard Revision Plan” on August 7th. 99 device standards are to be issued or revised. Click Here for more information.


Keep yourself updated with CFDA News Roundup, click HERE to opt-in. For market access newsletter, click HERE. For CRO services in China, click HERE.


About China Med Device, LLC

China Med Device, LLC (, a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD and combination-product companies to enter China. Our NMPA (CFDA) regulatory services include: regulatory strategy, RA, clinical evaluation, clinical trial, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership, distribution qualification and management. We are a NMPA (CFDA) certified legal agent. With offices in Boston and Beijing, we can service our clients 24/7.


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