NMPA published 54 draft guidelines on October 25, 2023, for feedback. Feedback needs to be submitted by November 23, 2023.
Significance of Device Guidelines
The guidelines are prepared by NMPA Center of Medical Device Evaluation (CMDE). They are not legally binding but are highly recommended by regulatory authorities.
For both renewals and new registrations, medical devices need to meet these new guidelines. Even if renewals (required every 5 years by NMPA) have no changes, manufacturers still have to prove that the originally approved products can meet the new guidelines. As a result, approved products still need to go through local type testing to show that they are current with these new requirements.
China Med Device, LLC has test engineers at NMPA testing centers to help you assess and expedite your type testing needs and shorten your renewal or new approval time.
Full List
For English version of any draft guidelines below, please email info@ChinaMedDevice.com. We charge nominal fees for the translation. We will also give you the email and phone number of contact person that NMPA assigned for the guideline.
- Guideline on Electric Photography Flat Bed
- Guideline on Medical Gas Alarm System
- Guideline on Air Oxygen Mixer
- Guideline on Laser Positioning System
- Guideline on In Vivo Electrodes For Nerve And Muscle Stimulators
- Guideline on Traditional Chinese Medicine Pulse Diagnosis Equipment
- Guideline on Rehabilitation Training Bed
- Guideline on Medical Gynecological Gel
- Guideline on Disposable Oxygen Mask
- Guideline on Nebulizer Mask
- Guideline on Bronchial Blocker
- Guideline on Medical Catheter Fixation Device
- Guideline on Respiratory Mask
- Guideline on Micromanipulation Tubes For Assisted Reproduction
- Guideline on Medical Sodium Hyaluronate Wound Dressing
- Guideline on Electrolyte Analyzer
- Guideline on Glucose Detection Reagent
- Guideline on Gram-Negative Bacilli Identification Reagent
- Guideline on Pyruvate Detection Reagent
- Guideline on Α-Amylase Detection Reagent
- Guideline on Alpha-Hydroxybutyrate Dehydrogenase Detection Reagent
- Guideline on Magnesium Detection Reagent
- Guideline on Semi-Automatic Chemiluminescent Immunoanalyzer
- Guideline on Dental Comprehensive Treatment Machine
- Guideline on Hearing Aid
- Guideline on X-Ray Diagnostic Equipment (Class II)
- Guideline on Medical Nebulizer
- Guideline on Creatine Kinase Detection Reagent
- Guideline on Positive Pressure Ventilation Therapy
- Guideline on Magnetic Therapy Products
- Guideline on Coagulation Analyzer
- Guideline on Medical Endoscope Cold Light Source
- Guideline on Sialic Acid Detection Kit (Enzymatic Method)
- Guideline on Β2-Microglobulin Detection Reagent
- Guideline on Lactate Dehydrogenase Assay Kit
- Guideline on Thyroid Stimulating Hormone Detection Reagent
- Guideline on Ischemia Modified Albumin Assay Kit
- Guideline on Glycated Hemoglobin Determination Kit (Enzymatic Method)
- Guideline on Vibration Percussion Expectoration Machine
- Guideline on Urine Analyzer
- Guideline on Peritoneal Dialysis Equipment
- Guideline on C-Reactive Protein Assay Kit
- Guideline on Medical Image Storage And Transmission System Software (Pacs)
- Guideline on Urine Formed Component Analyzer
- Guideline on Large Steam Sterilization
- Guideline on Alkaline Phosphatase Detection Reagent
- Guideline on Hemodialysis Water Making Equipment
- Guideline on Triglyceride Detection Reagent
- Guideline on Blood Glucose Meter
- Guideline on Human Chorionic Gonadotropin Detection Reagent (Colloidal Gold Immunochromatography)
- Guideline on Albumin Determination Reagent (Box)
- Guideline on Fecal Occult Blood (Fob) Detection Kit (Colloidal Gold Immunochromatography)
- Guideline on Electronic Blood Pressure Monitor (Oscillometric Method)
- Guideline on Biomedical Analyzer
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- Source: https://chinameddevice.com/guidelines-october/
