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  • NMPA medical device standards modifications announced in September 2022

NMPA medical device standards modifications announced in September 2022

NMPA medical device standards modifications
Thursday, 13 October 2022 / Published in Medical Device, News, NMPA Registration in China

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 transformation
1YY 0766-2009Ophthalmic lens ultrasound extraction and vitrectomy equipmentYY/T 0766-2009
2YY 0109-2013Medical Ultrasonic NebulizerYY/T 0109-2013
3YY 0460-2009Ultrasonic dental cleaning equipmentYY/T 0460-2009
4YY 0767-2009Ultrasound Color Flow Imaging SystemYY/T 0767-2009
5YY 0104-2018Trigon needleYY/T 0104-2018
6YY 0833-2020Limb compression physiotherapy equipment general technical requirementsYY/T 0833-2020
7YY 0951-2015Interference electrotherapy equipmentYY/T 0951-2015
8YY 0776-2010Liver radiofrequency ablation therapy equipmentYY/T 0776-2010
9YY 0860-2011Cardiac radiofrequency ablation therapy equipmentYY/T 0860-2011
10YY 0950-2015Pneumatic ballistic extracorporeal pressure wave therapy equipmentYY/T 0950-2015
11YY 0322-2018High frequency electrocautery treatment instrumentYY/T 0322-2018
12YY 0898-2013Millimeter wave therapy equipmentYY/T 0898-2013
13YY 0900-2013Weight loss walking training tableYY/T 0900-2013
14YY 0901-2013UV therapy equipmentYY/T 0901-2013
15YY 0952-2015Medical temperature control blanketYY/T 0952-2015
16YY 0003-1990Hospital BedYY/T 0003-1990
17YY 1057-2016General technical conditions for medical foot switchesYY/T 1057-2016
18YY 0001-2008Technical requirements for extracorporeal triggered lithotripsy equipmentYY/T 0001-2008
19YY 0290.5-2008Ophthalmic Optics Artificial Lens Part 5: BiocompatibilityYY/T 0290.5-2008
20YY 0633-2008Ophthalmic instruments Indirect ophthalmoscopyYY/T 0633-2008
21YY 0675-2008Ophthalmic Instruments Simultaneous Vision MachineYY/T 0675-2008
22YY 0676-2008Ophthalmic Instruments Visual Field MeterYY/T 0676-2008
23YY 0787-2010Ophthalmic Instruments Corneal TopographerYY/T 0787-2010
24YY 1080-2009Ophthalmic instruments Direct ophthalmoscopyYY/T 1080-2009
25YY 0847-2011Medical endoscopy Endoscopic instruments Lithotripsy mesh basketYY/T 0847-2011
26YY 0862-2011Ophthalmic Optics Intraocular FillersYY/T 0862-2011
27YY 0065-2016Ophthalmic Instruments Slit Lamp MicroscopeYY/T 0065-2016
28YY 0069-2009Special requirements for rigid endotracheal endoscopesYY/T 0069-2009
29YY 0788-2010Ophthalmic Instruments MicrokeratomeYY/T 0788-2010
30YY 1081-2011Medical endoscope Endoscope function supply device Cold light sourceYY/T 1081-2011
31YY 1298-2016Medical Endoscope Capsule EndoscopeYY/T 1298-2016
32YY 0068.2-2008Medical endoscopes Rigid endoscopes Part 2: Mechanical properties and test methodsYY/T 0068.2-2008
33YY 0678-2008Medical cryosurgery equipment performance and safetyYY/T 0678-2008
34YY 1028-2008Fiberoptic upper gastrointestinal endoscopyYY/T 1028-2008
35YY 0285.5-2018Intravascular Catheters Single-Use Sterile Catheters Part 5: Sleeve Needle Peripheral CathetersYY/T 0285.5-2018
36YY 0450.2-2003Single-use sterile intravascular catheter accessories Part 2: Sleeve needle peripheral catheter plugYY/T 0450.2-2003
37YY 0030-2004Peritoneal dialysis tubingYY/T 0030-2004
38YY 0332-2011Implantable drug delivery devicesYY/T 0332-2011
39YY 0483-2004Disposable enteral nutrition catheters, enteral feeders and their connections Design and test methodsYY/T 0483-2004
40YY 0488-2004Single-use sterile rectal catheterYY/T 0488-2004
41YY 0489-2004Disposable sterile drainage catheters and auxiliary devicesYY/T 0489-2004
42YY 0581.1-2011Infusion connectors Part 1: Puncture connectors (heparin caps)YY/T 0581.1-2011
43YY 0581.2-2011Infusion connections Part 2: Needle-free connectionsYY/T 0581.2-2011
44YY 0804-2010Infusion transfer device Requirements and test methodsYY/T 0804-2010
45YY 0881-2013Needles for single-use implantable drug delivery devicesYY/T 0881-2013
46YY 0484-2004Surgical implants Two-component molded vulcanized silicone rubberYY/T 0484-2004
47YY 0671-2021Medical devices Sleep apnea treatment Masks and application accessoriesYY/T 0671-2021
48YY 0893-2013Medical gas mixer Stand-alone gas mixerYY/T 0893-2013
49YY 1741-2021Antithrombin III assay kitYY/T 1741-2021
50YY 1271-2016Cardiopulmonary flow system Single-use suction tubeYY/T 1271-2016
51YY 1272-2016Dialysis fluid filterYY/T 1272-2016
52YY 1273-2016Rolling pump for blood purification assistanceYY/T 1273-2016
53YY 1274-2016Pressure-controlled peritoneal dialysis equipmentYY/T 1274-2016
54YY 1493-2016Gravity-controlled peritoneal dialysis equipmentYY/T 1493-2016
55YY 0091-2013Cervical dilatorYY/T 0091-2013
56YY 0092-2013Cervical biopsy forcepsYY/T 0092-2013
57YY 1023-2013Cervical clampYY/T 1023-2013
58YY 0045-2013General Delivery BedYY/T 0045-2013
59YY 1024-2013Fallopian tube extraction hookYY/T 1024-2013
60YY 0992-2016Endoscopic cleaning workstationYY/T 0992-2016
61YY 1621-2018Medical carbon dioxide incubatorYY/T 1621-2018
62YY 0075-2005Tear Duct ProbeYY/T 0075-2005
63YY 0174-2019Surgical bladesYY/T 0174-2019
64YY 0175-2005Scalpel handleYY/T 0175-2005
65YY 0672.2-2011Endoscopic instruments Part 2: Scissors for laparoscopyYY/T 0672.2-2011
66YY 0877-2013Holster stitchYY/T 0877-2013
67YY 91016-1999All Glass Syringe TerminologyYY/T 91016-1999
68YY 91017-1999All-glass syringe body tightness test methodYY/T 91017-1999
69YY 0462-2018Dentistry Academic Plaster ProductsYY/T 0462-2018
70YY 0711-2009Dental moisture-absorbing paper tipsYY/T 0711-2009
71YY 1027-2018Dentistry Hydrocolloid impression materialsYY/T 1027-2018
72YY 0302.1-2010Dental rotary instruments Turning needles Part 1: Steel and carbide turning needlesYY/T 0302.1-2010
73YY 0302.2-2016Dentistry Rotary instrument turning needles Part 2: Turning needles for trimmingYY/T 0302.2-2016
74YY 0761.1-2009Dentistry Diamond rotary instruments Part 1: Dimensions, requirements, marking and packagingYY/T 0761.1-2009
75YY 0803.3-2016Dentistry Root canal instruments Part 3: PressurizersYY/T 0803.3-2016
76YY 0835-2011Dentistry Silver Amalgam SeparatorYY/T 0835-2011
77YY 91064-1999Dental rotary instruments Technical conditions for steel and carbide dental drillsYY/T 91064-1999
78YY 0461-2003Breathing lines for anesthesia machines and ventilatorsYY/T 0461-2003
79YY 0773-2010Ophthalmology B-type ultrasound diagnostic instrument general technical conditionsYY/T 0773-2010
80YY 0849-2011Ophthalmic High Frequency Ultrasound Diagnostic InstrumentYY/T 0849-2011
81YY 0337.1-2002Tracheal intubation Part 1: Commonly used types of intubation and connectorsYY/T 0337.1-2002
82YY 0337.2-2002Tracheal intubation Part 2: Cole type intubationYY/T 0337.2-2002
83YY 0338.1-2002Tracheotomy intubation Part 1: Adult intubation and connectorsYY/T 0338.1-2002
84YY 0338.2-2002Tracheotomy intubation Part 2: Tracheotomy intubation for pediatric useYY/T 0338.2-2002
85YY 1468-2016Oxygen concentrator supply system for medical gas pipeline systemsYY/T 1468-2016
86YY 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.

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