NMPA released 20 industry standards on June 28, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions.
Significance of Standards
Industry mandatory standards are legally binding. 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.
China YY Standards are the industry standards as technical requirements for medical devices in China. YY Standards are issued by the National Medical Products Administration (NMPA). "YY" is the code for mandatory industry standards, while voluntary industry standards have the "YY/T".
Mandatory Standards
YY 0272-2023 Dentistry Zinc oxide/eugenol cement and eugenol-free zinc oxide cement
YY 0503-2023 Ethylene oxide sterilizer
YY 0793.3-2023 Preparation and quality management of fluids for hemodialysis and related therapeutic purposes Part 3: Concentrates for hemodialysis and related therapeutic purposes
YY 0989.3-2023 Surgical implants active implantable medical devices – Part 3: Implantable neurostimulators
YY 1881-2023 Medical positive pressure breathing apparatus
YY 1885-2023 Transportation of patients with infectious diseases in negative pressure isolation cabins
YY 1887-2023 Medical positive pressure protective clothing
Recommended Standards
YY/T 0338-2023 Tracheostomy cannula and fittings
YY/T 0776-2023 Liver radiofrequency ablation treatment equipment
YY/T 0907-2023 Medical needle-free syringe requirements and test methods
YY/T 0992-2023 Endoscope cleaning workstation
YY/T 1437-2023 Medical devices GB/T 42062 Application guide
YY/T 1754.3-2023 Preclinical animal studies of medical devices – Part 3: Animal abdominal wall incision hernia model for evaluation of mesh histological response and biomechanical properties
YY/T 1766.3-2023 Image quality evaluation method for X-ray computed tomography equipment Part 3: Performance evaluation of dual-energy imaging and spectroscopy application
YY/T 1873-2023 Anesthesia and respiratory equipment: Laughing gas inhalation sedative analgesic device
YY/T 1884-2023 Fixed copper-bearing IUD
YY/T 1894-2023 Reliability index verification method for medical magnetic resonance equipment
YY/T 1896-2023 Wavelength range definition method for spectral radiation therapy equipment
YY/T 1897-2023 Biological evaluation of nano-medical devices genotoxicity test In vitro mammalian cell micronucleus test
YY/T 1899-2023 Methods for preparation and evaluation of histopathological samples after implantation of absorbable medical devices
Huge Impact
Whether you are renewing or submitting a new registration, your medical devices need to meet these new standards. Even if your renewals (every 5 years required by NMPA) have no changes, you still have to prove that your originally approved products shall meet the requirements of new standards. Your originally approved products will still need to go through local type testing to show that they keep updated with these new requirements.
China technical standards are not always harmonized with the international technical standards such as the ISO or ASTM etc. I am interested to hear about your experience in dealing with the deviations. Please feel free to ask any specific questions about your experiences.
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Grace Fu
China Med Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------