NMPA published 48 medical devices guidelines on May 27, 2024. They are aimed to facilitate manufacturers with clarity in registration process.
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.
- Electric Photography Flatbed
- Medical Gas Alarm Device
- Air-Oxygen Blender
- Radiation Therapy Laser Positioning Equipment
- Nerve and Muscle Stimulator
- Rehabilitation Training Bed
- Electroencephalograph (EEG)
- Medical Gynecological Gel
- Disposable Oxygen Mask
- Nebulizer Mask
- Tracheal Obstructor
- Medical Catheter Fixation Device
- Respiratory Mask
- Micromanipulation Pipette for Assisted Reproduction
- Electrolyte Analyzer
- β2-Microglobulin Assay Reagent
- Thyroid-Stimulating Hormone Assay Reagent
- Ischemia-Modified Albumin Assay Kit
- Lactate Dehydrogenase Assay Kit
- Glycated Hemoglobin Assay Kit (Enzymatic Method)
- Sialic Acid Assay Kit (Enzymatic Method)
- C-Reactive Protein Assay Kit
- Peritoneal Dialysis Equipment
- Urine Analyzer
- Medical Image Storage and Transmission Software (PACS)
- Vibratory Percussor for Airway Clearance
- Large Pressure Steam Sterilizer
- Triglyceride Assay Reagent
- Alkaline Phosphatase Assay Reagent
- Urine Formed Elements Analyzer
- Water Treatment Equipment for Hemodialysis
- … …
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- Source: https://chinameddevice.com/devices-guidelines-may/
