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NMPA Issued Eight Guidelines in August

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The NMPA published eight new guidelines in August 2023, to direct manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions.

Full List

  • Clinical evaluation guideline on predicate comparison of positron emission/X-ray computed tomography system
  • Clinical evaluation guideline on predicate comparison of medical X-ray diagnostic equipment (Class III)
  • Clinical evaluation guideline on predicate comparison of dental implant system
  • Clinical evaluation guideline on predicate comparison of electronic endoscope
  • Clinical evaluation guideline on hemodialysis concentrates
  • Clinical evaluation guideline on soft contact lens
  • Registration guideline on disposable membrane oxygenator (for CPB)
  • Registration guideline on dialysate filter

For an English copy of any guideline above, please contact us at info@ChinaMedDevice.com. We charge nominal fees for the translation.

Significance of Device Guidelines

The guidelines are prepared by the NMPA Center of Medical Device Evaluation (CMDE). They are not legally binding but are 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.

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