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92 Standards Become Non-Binding

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The NMPA issued the “Announcement on the transformation of 92 mandatory industry standards and research projects for medical devices into recommended industry standards and research projects” on September 9, 2022. Devices from a range of indications, cardiovascular, ophthalmic, dental, and gynecology, etc. are impacted.

Importance of the Transformation

The announcement changes the status of 92 standards from “mandatory” to “recommended”, to keep up with the international requirements and ease the regulatory burden for manufacturers.

While Industry Mandatory Standards are legally enforced, the industry recommended standards are not legally binding but only recommended by regulatory authorities.

The 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”.

List of NMPA Medical Device Standards

The standards include but not limited to the following:

  • Ophthalmic Lens Ultrasonic Extraction and Vitrectomy Equipment
  • Medical Ultrasonic Nebulizer
  • Ultrasonic Scaling Equipment
  • Ultrasound Color Flow Imaging System
  • Three-edged needle
  • General technical requirements for limb compression physiotherapy equipment
  • Interfere with electrotherapy equipment
  • Liver radiofrequency ablation equipment
  • 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
  • Hospital bed
  • General technical requirements for medical foot switches
  • Technical requirements for in vitro induced lithotripsy equipment
  • 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
  • Medical endoscope Endoscopic instruments Stone extraction basket
  • Ophthalmic optics Intraocular fillers
  • Ophthalmic Instruments Slit Lamp Microscopes
  • Special requirements for rigid tracheal endoscopes
  • Ophthalmic Instruments Microkeratome
  • Medical endoscope function supply device: Cold light source
  • Medical endoscope Capsule endoscope
  • Medical endoscopes – Rigid endoscopes – Part 2: Mechanical properties and test methods
  • Performance and safety of medical cryosurgery equipment
  • Fiberoptic Upper Gastrointestinal Endoscopy
  • Intravascular Catheters Single-Use Sterile Catheters Part 5: Trocar Peripheral Catheters
  • Disposable Sterile Intravascular Catheter Accessories Part 2: Trocar Peripheral Catheter Plugs
  • Peritoneal dialysis tubing
  • Implantable Drug Delivery Device
  • Disposable enteral nutrition catheters, enteral feeders and their connectors – Design and test methods
  • Disposable sterile rectal catheter
  • Disposable sterile drainage catheter and auxiliary equipment
  • Infusion connectors – Part 1: Puncture connectors (heparin caps)
  • Infusion connectors – Part 2: Needleless connectors
  • Infusion transfer devices – Requirements and test methods
  • Single-use needle for implantable drug delivery device
  • … …

If you are interested in getting the complete list or an English version of any standards above, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.

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