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NMPA: Fourteen Guidelines Issued in One Day

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nmpa guidelines for nanomaterials

The NMPA published 14 guidelines on July 6, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions.

For English version of any guidelines below, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.

Full List of Guidelines July 2023

The guidelines impact the devices as follows:

  • blood melting device
  • respiratory humidifier
  • intestinal hydrotherapy machine
  • molecular sieve oxygen generator
  • bladder ultrasound scanner
  • single-use peritoneal dialysis catheters
  • respiratory filters
  • oropharyngeal/nasopharyngeal airway
  • liquid dressings
  • gel dressings
  • β-hydroxybutyric acid detection reagent
  • methotrexate detection reagent
  • anti-cyclic citrullinated peptide antibody detection reagent
  • Gram-positive bacteria identification reagent

Huge Impact

Whether you are renewing or submitting new registration, your medical devices need to meet these new guidelines. Even if your renewals (every 5 years required by NMPA) have no changes, you still have to prove that your originally approved products can meet the new guidelines.

As a result, your originally approved products will still need to go through local type testing to show that you are current with the new guidelines. 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.

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