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Twenty Industry Standards Issued in One Day

Twenty newly-established or revised industry standards were released by NMPA on February 19, 2024, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory submissions.

Full List

  • YY 1001—2024 All glass syringe
  • YY/T 0062.1-2024 Medical electrical equipment – Diagnostic X-rays – Part 1: Determination of equivalent filtration and inherent filtration
  • YY/T 0323—2024 Infrared thermal treatment equipment
  • YY/T 0331—2024 Performance requirements and test methods for absorbent cotton gauze and absorbent cotton viscose blended gauze
  • YY/T 0486—2024 Requirements for marking and accompanying information of endotracheal tubes for laser surgery
  • YY/T 0655—2024 Dry chemical analyzer
  • YY/T 0663.2—2024 Cardiovascular implantable devices Intravascular devices Part 2: Vascular stents
  • YY/T 0853—2024 Medical Varicose Vein Compression Stockings
  • YY/T 1200—2024 Glucose determination kit (enzymatic method)
  • YY/T 1256-2024 Ureaplasma urealyticum nucleic acid detection kit
  • YY/T 1549—2024 Calibrators for biochemical analyzers
  • YY/T 1740.3—2024 Medical mass spectrometer Part 3: Inductively coupled plasma mass spectrometer
  • YY/T 1766.4—2024 Image quality evaluation method for X-ray computed tomography equipment Part 4: Imaging performance evaluation under automatic exposure control
  • YY/T 1892-2024 Breakpoint Cluster Region-Abelson Leukemia Virus (BCR-ABL) Fusion Gene Detection Kit
  • YY/T 1898-2024 Intravascular Catheter Guide Wire Test Method for Firmness of Hydrophilic Coating
  • YY/T 1902-2024 Medical plasma quick freezing machine
  • YY/T 1903-2024 Cardiac single photon emission computed tomography device performance and test rules
  • YY/T 1925—2024 Cardiovascular implantable devices Neurovascular thrombectomy stents
  • YY/T 1927—2024 Sports medicine implantable devices with loop fixation plate
  • YY/T 1929-2024 Breast biopsy and rotational resection equipment

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 any standards above, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.