NMPA published the 27 registration review guidelines on September 15, 2022, which involve a wide range of indications, from chemistry, hematology to dental and urology, etc. It is to facilitate manufacturers with local type testing and make guidelines more consistent with the international counterparts.
Importance of Device Guideline
The guidelines are prepared by NMPA Center of Medical Device Evaluation (CMDE). It is not legally binding but 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 need 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. info@ChinaMedDevice.com.
The guidelines include but not limited to the following:
- Guideline on Fibrin Monomer Assay Reagent
- Guideline on Vascular Clip
- Guideline on Estradiol Detection Reagent
- Guideline on Prealbumin Detection Reagent
- Guideline on Glycated Hemoglobin Analyzer
- Guideline on Disposable EEG Electrodes
- Guideline on High Sensitivity Cardiac Troponin Detection Reagent
- Guideline on Medical Sterile Ultrasound Couplant
- Guideline on Cyclosporine and Tacrolimus Detection Reagent
- Guideline on Heart-shaped Fatty Acid Binding Protein Assay Reagent
- Guideline on Acid Oxidation Potential Water Generator
- Guideline on Fecal Calprotectin Detection Reagent
- Guideline on Central Oxygen Supply System
- Guideline on Dental Sandblasting Powder
- Guideline on Fungal (1-3)-β-D Glucan Assay Reagent
- Guideline on Dental Root Canal Lubricant Cleaner
- … …
For the English version of any guidelines listed above, please email info@ChinaMedDevice.com.