NMPA published the “2021 Medical Device Guidelines Revisions Plan” on June 23, 2022, in which 75 guidelines are affected. The revisions are aimed 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 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. info@ChinaMedDevice.com.

Guidelines to be Revised

The plan involves the guidelines for technical review for type testing, clinical trial and registration, and Indication for Use (IFU) writing. The revisions include but not limited to the following:

• Implantable interventional medical device batteries
• Remote monitoring medical devices
• Atrial fibrillation detection products
• Single use pressure sensor
• Invasive blood pressure monitoring equipment
• Non-invasive blood glucose/glucose monitoring products
• High flow heated humidification therapy equipment
• Insulin Pump
• Pulmonary nodule CT image-aided detection software
• Continuous glucose monitoring system
• Laparoscopic surgery system
• Radiofrequency (non-ablation) devices
• Shear wave ultrasound diagnostic equipment for liver cirrhosis
• Ophthalmic optical biometer
• Ultrasonic soft tissue cutting hemostatic device
• Intense pulsed light therapy device
• Vascular interventional devices with lubricating coatings
• non-vascular stent
• Preclinical study of drug-coated balloon dilatation catheter
• Intravascular foreign body removal device
• Transcatheter implantation of aortic prosthetic heart valve
• hernia repair patch
• breast implants
• Medical device product benefit-risk Analysis
• Rigid contact lens instructions
• Soft contact lens instructions
• Contact lens care
• Recombinant humanized collagen raw material
• dental adhesive
• Artificial shoulder joint prosthesis system
• 3D printed interbody cage
• percutaneous enteral nutrition catheter
• Disposable intravenous nutrition infusion bag
• Disposable human arterial blood sample collector
• Needleless syringe
• single use infusion set
• Disposable dialyzer
• hemodialysis concentrate
• Disposable blood separation device
• Disposable light-proof infusion set
• High-throughput gene sequencer for non-clinical research
• Main raw materials of in vitro diagnostic reagents
• … …

For the compete list of guidelines revisions, please email info@ChinaMedDevice.com.