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Hundreds of Standards to be Obsoleted or Declassified: Faster Market Access for Ophthalmic and Orthopedic Devices

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The NMPA issued the “Optimizing Mandatory Standards for Medical Devices (Draft)” on January 5, 2022 for feedback. Feedbacks need to be submitted by February 10. The document lists 458 standards, many of which are for ophthalmic and orthopedic indications, proposing to make changes by obsoleting, keeping in effect or declassifying from “mandatory” to “recommended”.

No Longer Legally Binding

National mandatory standards and industry mandatory standards are legally enforced. Decree 739 Regulation on Supervision and Management of Medical Devices, the highest law governing medical device industry in China, mandates that “medical device shall meet the national mandatory standards; if there are no national mandatory standards, they shall comply with the industry mandatory standards”.

The industry recommended standards are not legally binding but recommended by regulatory authorities.

For English version of the Decree 739 Regulation on Supervision and Management of Medical Devices, please email info@ChinaMedDevice.com.

List of Standards

NMPA proposed to make changes to the following standards:

To be obsoleted:

  • Medical electrical equipment – Part 2: Particular requirements for the safety of high-voltage generators for diagnostic X-ray generators
  • Medical electrical equipment – Part 2: Particular requirements for the safety of ancillary equipment for X-ray equipment
  • Medical electrical equipment – Part 2: Particular requirements for the safety of dosimeters used in radiation therapy in contact with the patient and having an electrically connected radiation detector
  • Ophthalmic optics – Intraocular lenses – Part 9: Multifocal intraocular lenses
  • Rigid hysteroscopy
  • Rigid arthroscopy
  • Fiberoptic cystoscope

To be declassified from mandatory standards to recommended standards:

  • Type B Ultrasound Diagnostic Equipment
  • Ophthalmic Lens Ultrasonic Extraction and Vitrectomy Equipment
  • General technical requirements for ophthalmic B-type ultrasonic diagnostic apparatus
  • Ophthalmology high frequency ultrasound diagnostic instrument
  • Medical Ultrasonic Nebulizer
  • Medical Ultrasound Couplant
  • Ultrasonic Scaling Equipment
  • Ultrasound Color Flow Imaging System
  • Liver radiofrequency ablation equipment
  • Three-edged needle
  • Cardiac radiofrequency ablation equipment
  • Pneumatic Ballistic Extracorporeal Pressure Wave Therapy Equipment
  • High frequency electrocautery therapy device
  • Millimeter wave therapy equipment
  • Weight loss walking Trainer
  • UV therapy equipment
  • Medical temperature control blanket
  • Ophthalmic optics – Intraocular lenses – Part 5: Biocompatibility
  • Ophthalmic Instruments Indirect Ophthalmoscope
  • Ophthalmic Instruments Synoptics
  • Ophthalmic Instruments Perimeter
  • Ophthalmic Instruments Corneal Topographer
  • Ophthalmic Instruments Direct Ophthalmoscope
  • Ophthalmic instruments Fundus camera
  • Medical endoscope Endoscopic instruments Stone extraction basket
  • Ophthalmic optics Intraocular fillers
  • Ophthalmic Instruments Slit Lamp Microscopes

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