NMPA medical device standards modifications announced in September 2022

NMPA medical device standards modifications were announced on September 7, 2022, and came into effect immediately. Eighty-six (86) NMPA medical device standards have been modified following evaluation work on the optimization of mandatory medical device standards in China. These 86 mandatory standards have been transformed into recommended standards along with another 6 mandatory industry standard research projects which have also been transformed into recommended ones.

From the date of publication, the above-mentioned standard code is changed from YY to YY/T, however, each standard’s serial number and year code remain unchanged.

Standard list

No.Original standard numberStandard nameStandard number after transformation1YY 0766-2009Ophthalmic lens ultrasound extraction and vitrectomy equipmentYY/T 0766-20092YY 0109-2013Medical Ultrasonic NebulizerYY/T 0109-20133YY 0460-2009Ultrasonic dental cleaning equipmentYY/T 0460-20094YY 0767-2009Ultrasound Color Flow Imaging SystemYY/T 0767-20095YY 0104-2018Trigon needleYY/T 0104-20186YY 0833-2020Limb compression physiotherapy equipment general technical requirementsYY/T 0833-20207YY 0951-2015Interference electrotherapy equipmentYY/T 0951-20158YY 0776-2010Liver radiofrequency ablation therapy equipmentYY/T 0776-20109YY 0860-2011Cardiac radiofrequency ablation therapy equipmentYY/T 0860-201110YY 0950-2015Pneumatic ballistic extracorporeal pressure wave therapy equipmentYY/T 0950-201511YY 0322-2018High frequency electrocautery treatment instrumentYY/T 0322-201812YY 0898-2013Millimeter wave therapy equipmentYY/T 0898-201313YY 0900-2013Weight loss walking training tableYY/T 0900-201314YY 0901-2013UV therapy equipmentYY/T 0901-201315YY 0952-2015Medical temperature control blanketYY/T 0952-201516YY 0003-1990Hospital BedYY/T 0003-199017YY 1057-2016General technical conditions for medical foot switchesYY/T 1057-201618YY 0001－2008Technical requirements for extracorporeal triggered lithotripsy equipmentYY/T 0001－200819YY 0290.5-2008Ophthalmic Optics Artificial Lens Part 5: BiocompatibilityYY/T 0290.5-200820YY 0633-2008Ophthalmic instruments Indirect ophthalmoscopyYY/T 0633-200821YY 0675-2008Ophthalmic Instruments Simultaneous Vision MachineYY/T 0675-200822YY 0676-2008Ophthalmic Instruments Visual Field MeterYY/T 0676-200823YY 0787-2010Ophthalmic Instruments Corneal TopographerYY/T 0787-201024YY 1080-2009Ophthalmic instruments Direct ophthalmoscopyYY/T 1080-200925YY 0847-2011Medical endoscopy Endoscopic instruments Lithotripsy mesh basketYY/T 0847-201126YY 0862-2011Ophthalmic Optics Intraocular FillersYY/T 0862-201127YY 0065-2016Ophthalmic Instruments Slit Lamp MicroscopeYY/T 0065-201628YY 0069-2009Special requirements for rigid endotracheal endoscopesYY/T 0069-200929YY 0788-2010Ophthalmic Instruments MicrokeratomeYY/T 0788-201030YY 1081-2011Medical endoscope Endoscope function supply device Cold light sourceYY/T 1081-201131YY 1298-2016Medical Endoscope Capsule EndoscopeYY/T 1298-201632YY 0068.2-2008Medical endoscopes Rigid endoscopes Part 2: Mechanical properties and test methodsYY/T 0068.2-200833YY 0678-2008Medical cryosurgery equipment performance and safetyYY/T 0678-200834YY 1028-2008Fiberoptic upper gastrointestinal endoscopyYY/T 1028-200835YY 0285.5-2018Intravascular Catheters Single-Use Sterile Catheters Part 5: Sleeve Needle Peripheral CathetersYY/T 0285.5-201836YY 0450.2-2003Single-use sterile intravascular catheter accessories Part 2: Sleeve needle peripheral catheter plugYY/T 0450.2-200337YY 0030-2004Peritoneal dialysis tubingYY/T 0030-200438YY 0332-2011Implantable drug delivery devicesYY/T 0332-201139YY 0483-2004Disposable enteral nutrition catheters, enteral feeders and their connections Design and test methodsYY/T 0483-200440YY 0488-2004Single-use sterile rectal catheterYY/T 0488-200441YY 0489-2004Disposable sterile drainage catheters and auxiliary devicesYY/T 0489-200442YY 0581.1-2011Infusion connectors Part 1: Puncture connectors (heparin caps)YY/T 0581.1-201143YY 0581.2-2011Infusion connections Part 2: Needle-free connectionsYY/T 0581.2-201144YY 0804-2010Infusion transfer device Requirements and test methodsYY/T 0804-201045YY 0881-2013Needles for single-use implantable drug delivery devicesYY/T 0881-201346YY 0484-2004Surgical implants Two-component molded vulcanized silicone rubberYY/T 0484-200447YY 0671-2021Medical devices Sleep apnea treatment Masks and application accessoriesYY/T 0671-202148YY 0893-2013Medical gas mixer Stand-alone gas mixerYY/T 0893-201349YY 1741-2021Antithrombin III assay kitYY/T 1741-202150YY 1271-2016Cardiopulmonary flow system Single-use suction tubeYY/T 1271-201651YY 1272-2016Dialysis fluid filterYY/T 1272-201652YY 1273-2016Rolling pump for blood purification assistanceYY/T 1273-201653YY 1274-2016Pressure-controlled peritoneal dialysis equipmentYY/T 1274-201654YY 1493-2016Gravity-controlled peritoneal dialysis equipmentYY/T 1493-201655YY 0091-2013Cervical dilatorYY/T 0091-201356YY 0092-2013Cervical biopsy forcepsYY/T 0092-201357YY 1023-2013Cervical clampYY/T 1023-201358YY 0045-2013General Delivery BedYY/T 0045-201359YY 1024-2013Fallopian tube extraction hookYY/T 1024-201360YY 0992-2016Endoscopic cleaning workstationYY/T 0992-201661YY 1621-2018Medical carbon dioxide incubatorYY/T 1621-201862YY 0075-2005Tear Duct ProbeYY/T 0075-200563YY 0174-2019Surgical bladesYY/T 0174-201964YY 0175-2005Scalpel handleYY/T 0175-200565YY 0672.2-2011Endoscopic instruments Part 2: Scissors for laparoscopyYY/T 0672.2-201166YY 0877-2013Holster stitchYY/T 0877-201367YY 91016-1999All Glass Syringe TerminologyYY/T 91016-199968YY 91017-1999All-glass syringe body tightness test methodYY/T 91017-199969YY 0462-2018Dentistry Academic Plaster ProductsYY/T 0462-201870YY 0711-2009Dental moisture-absorbing paper tipsYY/T 0711-200971YY 1027-2018Dentistry Hydrocolloid impression materialsYY/T 1027-201872YY 0302.1-2010Dental rotary instruments Turning needles Part 1: Steel and carbide turning needlesYY/T 0302.1-201073YY 0302.2-2016Dentistry Rotary instrument turning needles Part 2: Turning needles for trimmingYY/T 0302.2-201674YY 0761.1-2009Dentistry Diamond rotary instruments Part 1: Dimensions, requirements, marking and packagingYY/T 0761.1-200975YY 0803.3-2016Dentistry Root canal instruments Part 3: PressurizersYY/T 0803.3-201676YY 0835-2011Dentistry Silver Amalgam SeparatorYY/T 0835-201177YY 91064-1999Dental rotary instruments Technical conditions for steel and carbide dental drillsYY/T 91064-199978YY 0461-2003Breathing lines for anesthesia machines and ventilatorsYY/T 0461-200379YY 0773-2010Ophthalmology B-type ultrasound diagnostic instrument general technical conditionsYY/T 0773-201080YY 0849-2011Ophthalmic High Frequency Ultrasound Diagnostic InstrumentYY/T 0849-201181YY 0337.1-2002Tracheal intubation Part 1: Commonly used types of intubation and connectorsYY/T 0337.1-200282YY 0337.2-2002Tracheal intubation Part 2: Cole type intubationYY/T 0337.2-200283YY 0338.1-2002Tracheotomy intubation Part 1: Adult intubation and connectorsYY/T 0338.1-200284YY 0338.2-2002Tracheotomy intubation Part 2: Tracheotomy intubation for pediatric useYY/T 0338.2-200285YY 1468-2016Oxygen concentrator supply system for medical gas pipeline systemsYY/T 1468-201686YY 0844-2011Laser therapy equipment Pulsed carbon dioxide laser therapy machineYY/T 0844-2011

Implications for NMPA medical device registration

Both mandatory standards and recommended standards have guiding significance for writing the performance indicators of the Product Technical Requirements (PTR) which is an integral part of medical device registrations in China.

The transformation of the standards has a guiding significance for the process of writing the Product Technical Requirements (PTR) which is an integral part of medical device registrations in China.

A declared product must meet mandatory standards, whereas the applicability of recommended standards will be determined according to the declared product.

The impact of the transformation of mandatory standards to recommended standards on registrants is as follows:

Mandatory standard: The declared product must refer to the mandatory standard, and it shall meet the requirements of the clauses, and explain any inapplicable clauses.
Mandatory standards transformed into recommended standards: The declared product may refer to the recommended standard, the applicable clauses should be quoted and meet the requirements, and the non-cited clauses do not need to be explained.
For products in the registration process, if the tests are not yet completed, and the mandatory standard cited by the registered product has been converted into a recommended standard, the applicable terms can be adjusted according to the technical performance indicators of the product.
For products in the registration process where the product has already completed testing, but no registration application has been submitted yet, performance indicators in the technical requirements can be adjusted appropriately.
The transformation of the above-mentioned six medical device projects from mandatory industry standards to recommended industry standards has no impact on existing registered projects.

Further information

Please refer to the links below for the full list of NMPA medical device standards modifications:

Appendix 1：List of 86 mandatory industry standards for medical devices transformed into recommended industry standards

Appendix 2：List of 6 medical device mandatory industry standards under research into recommended industry standards under research

If you would like to know how the NMPA medical device standards modifications affect your medical device or our registration and CRO services for pharmaceuticals, medical devices, IVDs, cosmetics, health foods, and industrial or consumer goods please contact us.