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34 NMPA Guidelines issued in December 2021

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The NMPA published 34 guidelines in December 2021, involving provisions on clinical trials, same-variety comparison, and regulatory review for a wide range of indications.

Significantly referred to many FDA guidance, these documents are aimed to make NMPA regulations more consistent with international standards.

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 (every 5 years required 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.

Complete List

Clinical trial

  • Non-patented companion diagnostic reagents for anti-tumor drugs
  • In vitro diagnostic reagents using overseas clinical data

Same-variety comparison

  • Nerve and Cardiovascular Surgical Instruments-Knives, Scissors and Needles
  • Microwave ablation equipment

Regulatory review

  • Endoscopic surgery energy equipment
  • Passive surgical instruments under arthroscopy
  • Disposable ureteral introducer sheath
  • Orthodontic wire
  • Disposal minimally invasive fascial closure device
  • Anesthesia mask
  • Non-vascular luminal guide wire
  • Circumcision stapler
  • Dental desensitizer
  • Extracorporeal Membrane Oxygenation (ECMO) Circulation Kit
  • Disposal abdominal puncture
  • Ossicle prosthesis products
  • Artificial ligament injection
  • Pectus forming system
  • Fluorescence immunochromatography analyzer
  • Net atomizer
  • Diagnostic X-ray equipment for pediatric applications
  • Ultrasound transcranial doppler blood flow analyzer
  • Hydrogen peroxide sterilizer
  • Newborn blue light apparatus
  • Root canal preparation machine
  • Blood cell analyzer
  • Gait training equipment
  • Pepsinogen I/II detection reagent
  • Prothrombin time/activated partial thromboplastin time/thrombin time/fibrinogen detection reagent
  • Retinol binding protein determination kit (immunoturbidimetric method)
  • Folic acid determination reagent
  • Anti-Mullerian hormone reagent

For an English version of the any guidelines above, please contact us at info@ChinaMedDevice.com. We charge nominal fees for the translations.

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