Contact Lens Guideline and 28 Others Issued in April

NMPA published the 29 guidelines in April 2023, which involve a wide range of indications, from ophthalmic, vascular to urology and cosmetic device, 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.

Guidelines List

The guidelines impact the following devices:

• Quantitative shear wave ultrasound liver measuring instrument
• RF beauty equipment
• Drug-coated balloon dilation catheter
• Endovascular salvage device
• Hernia repair patch
• Soft hydrophilic contact lenses
• Rigid contact lens
• Abdominal endoscopic surgical system (registration review)
• Abdominal endoscopic surgical system (clinical evaluation)
• Tracheal intubation products
• Single-use surgical gowns
• Natural latex rubber condom
• Single-use vacuum blood collection tubes
• Denture alloys
• Negative pressure drainage device
• Medical masks
• Gastric tube
• Surgical power equipment
• Breathing lines for anesthesia machines and ventilators
• Flow cytometry detection reagent
• Disposable nasal oxygen tubing
• Single-use drains
• Single-use sterile surgical kits
• Hemodialysis concentrate
• Hemodialyzers
• Single-use blood separation device
• Single-use infusion equipment
• Single-use light-protected infusion sets
• Applied Nanomaterials (Safety and Efficacy Evaluation Part II: Physical and Chemical Characterization)

For the English version of any guidelines listed above, please email info@ChinaMedDevice.com.

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• Source: https://chinameddevice.com/guidelines-april/