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 number | Standard name | Standard number after transformation |
1 | YY 0766-2009 | Ophthalmic lens ultrasound extraction and vitrectomy equipment | YY/T 0766-2009 |
2 | YY 0109-2013 | Medical Ultrasonic Nebulizer | YY/T 0109-2013 |
3 | YY 0460-2009 | Ultrasonic dental cleaning equipment | YY/T 0460-2009 |
4 | YY 0767-2009 | Ultrasound Color Flow Imaging System | YY/T 0767-2009 |
5 | YY 0104-2018 | Trigon needle | YY/T 0104-2018 |
6 | YY 0833-2020 | Limb compression physiotherapy equipment general technical requirements | YY/T 0833-2020 |
7 | YY 0951-2015 | Interference electrotherapy equipment | YY/T 0951-2015 |
8 | YY 0776-2010 | Liver radiofrequency ablation therapy equipment | YY/T 0776-2010 |
9 | YY 0860-2011 | Cardiac radiofrequency ablation therapy equipment | YY/T 0860-2011 |
10 | YY 0950-2015 | Pneumatic ballistic extracorporeal pressure wave therapy equipment | YY/T 0950-2015 |
11 | YY 0322-2018 | High frequency electrocautery treatment instrument | YY/T 0322-2018 |
12 | YY 0898-2013 | Millimeter wave therapy equipment | YY/T 0898-2013 |
13 | YY 0900-2013 | Weight loss walking training table | YY/T 0900-2013 |
14 | YY 0901-2013 | UV therapy equipment | YY/T 0901-2013 |
15 | YY 0952-2015 | Medical temperature control blanket | YY/T 0952-2015 |
16 | YY 0003-1990 | Hospital Bed | YY/T 0003-1990 |
17 | YY 1057-2016 | General technical conditions for medical foot switches | YY/T 1057-2016 |
18 | YY 0001-2008 | Technical requirements for extracorporeal triggered lithotripsy equipment | YY/T 0001-2008 |
19 | YY 0290.5-2008 | Ophthalmic Optics Artificial Lens Part 5: Biocompatibility | YY/T 0290.5-2008 |
20 | YY 0633-2008 | Ophthalmic instruments Indirect ophthalmoscopy | YY/T 0633-2008 |
21 | YY 0675-2008 | Ophthalmic Instruments Simultaneous Vision Machine | YY/T 0675-2008 |
22 | YY 0676-2008 | Ophthalmic Instruments Visual Field Meter | YY/T 0676-2008 |
23 | YY 0787-2010 | Ophthalmic Instruments Corneal Topographer | YY/T 0787-2010 |
24 | YY 1080-2009 | Ophthalmic instruments Direct ophthalmoscopy | YY/T 1080-2009 |
25 | YY 0847-2011 | Medical endoscopy Endoscopic instruments Lithotripsy mesh basket | YY/T 0847-2011 |
26 | YY 0862-2011 | Ophthalmic Optics Intraocular Fillers | YY/T 0862-2011 |
27 | YY 0065-2016 | Ophthalmic Instruments Slit Lamp Microscope | YY/T 0065-2016 |
28 | YY 0069-2009 | Special requirements for rigid endotracheal endoscopes | YY/T 0069-2009 |
29 | YY 0788-2010 | Ophthalmic Instruments Microkeratome | YY/T 0788-2010 |
30 | YY 1081-2011 | Medical endoscope Endoscope function supply device Cold light source | YY/T 1081-2011 |
31 | YY 1298-2016 | Medical Endoscope Capsule Endoscope | YY/T 1298-2016 |
32 | YY 0068.2-2008 | Medical endoscopes Rigid endoscopes Part 2: Mechanical properties and test methods | YY/T 0068.2-2008 |
33 | YY 0678-2008 | Medical cryosurgery equipment performance and safety | YY/T 0678-2008 |
34 | YY 1028-2008 | Fiberoptic upper gastrointestinal endoscopy | YY/T 1028-2008 |
35 | YY 0285.5-2018 | Intravascular Catheters Single-Use Sterile Catheters Part 5: Sleeve Needle Peripheral Catheters | YY/T 0285.5-2018 |
36 | YY 0450.2-2003 | Single-use sterile intravascular catheter accessories Part 2: Sleeve needle peripheral catheter plug | YY/T 0450.2-2003 |
37 | YY 0030-2004 | Peritoneal dialysis tubing | YY/T 0030-2004 |
38 | YY 0332-2011 | Implantable drug delivery devices | YY/T 0332-2011 |
39 | YY 0483-2004 | Disposable enteral nutrition catheters, enteral feeders and their connections Design and test methods | YY/T 0483-2004 |
40 | YY 0488-2004 | Single-use sterile rectal catheter | YY/T 0488-2004 |
41 | YY 0489-2004 | Disposable sterile drainage catheters and auxiliary devices | YY/T 0489-2004 |
42 | YY 0581.1-2011 | Infusion connectors Part 1: Puncture connectors (heparin caps) | YY/T 0581.1-2011 |
43 | YY 0581.2-2011 | Infusion connections Part 2: Needle-free connections | YY/T 0581.2-2011 |
44 | YY 0804-2010 | Infusion transfer device Requirements and test methods | YY/T 0804-2010 |
45 | YY 0881-2013 | Needles for single-use implantable drug delivery devices | YY/T 0881-2013 |
46 | YY 0484-2004 | Surgical implants Two-component molded vulcanized silicone rubber | YY/T 0484-2004 |
47 | YY 0671-2021 | Medical devices Sleep apnea treatment Masks and application accessories | YY/T 0671-2021 |
48 | YY 0893-2013 | Medical gas mixer Stand-alone gas mixer | YY/T 0893-2013 |
49 | YY 1741-2021 | Antithrombin III assay kit | YY/T 1741-2021 |
50 | YY 1271-2016 | Cardiopulmonary flow system Single-use suction tube | YY/T 1271-2016 |
51 | YY 1272-2016 | Dialysis fluid filter | YY/T 1272-2016 |
52 | YY 1273-2016 | Rolling pump for blood purification assistance | YY/T 1273-2016 |
53 | YY 1274-2016 | Pressure-controlled peritoneal dialysis equipment | YY/T 1274-2016 |
54 | YY 1493-2016 | Gravity-controlled peritoneal dialysis equipment | YY/T 1493-2016 |
55 | YY 0091-2013 | Cervical dilator | YY/T 0091-2013 |
56 | YY 0092-2013 | Cervical biopsy forceps | YY/T 0092-2013 |
57 | YY 1023-2013 | Cervical clamp | YY/T 1023-2013 |
58 | YY 0045-2013 | General Delivery Bed | YY/T 0045-2013 |
59 | YY 1024-2013 | Fallopian tube extraction hook | YY/T 1024-2013 |
60 | YY 0992-2016 | Endoscopic cleaning workstation | YY/T 0992-2016 |
61 | YY 1621-2018 | Medical carbon dioxide incubator | YY/T 1621-2018 |
62 | YY 0075-2005 | Tear Duct Probe | YY/T 0075-2005 |
63 | YY 0174-2019 | Surgical blades | YY/T 0174-2019 |
64 | YY 0175-2005 | Scalpel handle | YY/T 0175-2005 |
65 | YY 0672.2-2011 | Endoscopic instruments Part 2: Scissors for laparoscopy | YY/T 0672.2-2011 |
66 | YY 0877-2013 | Holster stitch | YY/T 0877-2013 |
67 | YY 91016-1999 | All Glass Syringe Terminology | YY/T 91016-1999 |
68 | YY 91017-1999 | All-glass syringe body tightness test method | YY/T 91017-1999 |
69 | YY 0462-2018 | Dentistry Academic Plaster Products | YY/T 0462-2018 |
70 | YY 0711-2009 | Dental moisture-absorbing paper tips | YY/T 0711-2009 |
71 | YY 1027-2018 | Dentistry Hydrocolloid impression materials | YY/T 1027-2018 |
72 | YY 0302.1-2010 | Dental rotary instruments Turning needles Part 1: Steel and carbide turning needles | YY/T 0302.1-2010 |
73 | YY 0302.2-2016 | Dentistry Rotary instrument turning needles Part 2: Turning needles for trimming | YY/T 0302.2-2016 |
74 | YY 0761.1-2009 | Dentistry Diamond rotary instruments Part 1: Dimensions, requirements, marking and packaging | YY/T 0761.1-2009 |
75 | YY 0803.3-2016 | Dentistry Root canal instruments Part 3: Pressurizers | YY/T 0803.3-2016 |
76 | YY 0835-2011 | Dentistry Silver Amalgam Separator | YY/T 0835-2011 |
77 | YY 91064-1999 | Dental rotary instruments Technical conditions for steel and carbide dental drills | YY/T 91064-1999 |
78 | YY 0461-2003 | Breathing lines for anesthesia machines and ventilators | YY/T 0461-2003 |
79 | YY 0773-2010 | Ophthalmology B-type ultrasound diagnostic instrument general technical conditions | YY/T 0773-2010 |
80 | YY 0849-2011 | Ophthalmic High Frequency Ultrasound Diagnostic Instrument | YY/T 0849-2011 |
81 | YY 0337.1-2002 | Tracheal intubation Part 1: Commonly used types of intubation and connectors | YY/T 0337.1-2002 |
82 | YY 0337.2-2002 | Tracheal intubation Part 2: Cole type intubation | YY/T 0337.2-2002 |
83 | YY 0338.1-2002 | Tracheotomy intubation Part 1: Adult intubation and connectors | YY/T 0338.1-2002 |
84 | YY 0338.2-2002 | Tracheotomy intubation Part 2: Tracheotomy intubation for pediatric use | YY/T 0338.2-2002 |
85 | YY 1468-2016 | Oxygen concentrator supply system for medical gas pipeline systems | YY/T 1468-2016 |
86 | YY 0844-2011 | Laser therapy equipment Pulsed carbon dioxide laser therapy machine | YY/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:
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.