G/TBT/N/CHN/1183  
 
28 November 2016  
(16-6508) Page: 1/2 
Committee on Technical Barriers to  Trade  Original : English  
 
  NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member : CHINA   
If applicable, name of local government involved  (Article 3.2 and 7.2) : 
2. Agency responsible : China Food and Drug Administration (CFD A) 
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification  shall be indicated if different from above :  
3. Notified under Article 2.9 .2 [ ], 2.10.1 [  ], 5.6.2 [ X], 5.7.1 [  ], other : 
4. Products covered (HS: or CCCN where applicable, otherwise national tariff 
heading. ICS: numbers may be provided in addition, where applicable) : Medical 
devices . 
Orthopaedic appliances, including crutches , surgical belts and trusses; splints and other 
fracture appliances; artificial parts of the body; hearing aids and other appliances which are 
worn or carried, or implanted in the body, to compensate for a defect or disability. 
(HS: 9021), Apparatus based on the use of X -rays or of alpha, beta or gamma radiations, 
whether or not for medical, surgical, dental or veterinary uses, including radiography or 
radiotherapy apparatus, X -ray tubes and other X -ray generators, high tension generators, 
control panels an d desks, screens, examination or treatment tables, chairs and the like. 
(HS: 9022), Instruments, apparatus and models, designed for demonstrational purposes (for 
example, in education or exhibitions), unsuitable for other uses. ( HS: 9023), Machines and 
appliances for testing the hardness, strength, compressibility, elasticity or other mechanical 
properties of materials (for example, metals, wood, textiles, paper, plastics). ( HS: 9024), 
Hydrometers and similar floating instruments, thermometers, pyrometers, barometers, 
hygrometers and psychrometers, recording or not, and any combination of these 
instruments. ( HS: 9025), Instruments and apparatus for measuring or checking the flow, 
level, pressure or other variables of liquids or gases (for example, flowmeters , level gauges, 
manometers, heat meters), excluding instruments and apparatus of heading 90.14, 90.15, 
90.28 or 90.32. ( HS: 9026), Instruments and apparatus for physical or chemical analysis 
(for example, polarimeters, refractometers, spectrometers, gas or  smoke analysis 
apparatus); instruments and apparatus for measuring or checking viscosity, porosity, 
expansion, surface tension or the like; instruments and apparatus for measuring or checking 
quantities of heat, sound or light (including exposure meters);  microtomes. ( HS: 9027), Gas, 
liquid or electricity supply or production meters, including calibrating meters therefor. 
(HS: 9028), Revolution counters, production counters, taximeters, mileometers, pedometers 
and the like; speed indicators and tachometers , other than those of heading 90.14 or 90.15; 
stroboscopes. ( HS: 9029), Oscilloscopes, spectrum analysers and other instruments and 
apparatus for measuring or checking electrical quantities, excluding meters of heading 
90.28; instruments and apparatus for measuring or detecting alpha, beta, gamma, X -ray, 
cosmic or other ionising radiations. ( HS: 9030), Measuring or checking instruments, 
appliances and machines, not specified or included elsewhere in this Chapter; profile 
projectors. ( HS: 9031), Automatic re gulating or controlling instruments and apparatus. 
(HS: 9032), Parts and accessories (not specified or included elsewhere in this Chapter) for 
machines, appliances, instruments or apparatus of Chapter 90. ( HS: 9033) . Health care 
technology (ICS: 11) G/TBT/N/CHN/1183  
 
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  5. Title, number of pages  and language(s)  of the notified document : Catalog on Medical 
Device Classification (Revised Edition) (156 pages, in Chinese)   
6. Description of content : Following the Rules for Classification of Medical Devices (Decree 
No. 15 of China  Food and Drug Administration), Catalog on Medical  Device  Classification  
(Revised  Edition) is a normative document combining intended purpose, structural 
characteristics, pattern of use, and other related factors so as to determine the risk degree 
of medic al devices. Catalog on Medical  Device  Classification (Revised  Edition) contains 
22 subdirectories including active surgical categories, 205 first level categories of products, 
1136 second level product categories and 5641 typical examples of product names.  This 
catalog does not contain the content of Classification Catalog on 6840 Vitro Diagnostic 
Products (2013 Edition), medical device kit or non -medical device product.  
7. Objective and rationale , including the nature of urgent problems where 
applicable : Protection of human health or safety  
8. Relevant documents : None 
9. Proposed date of adoption : To be determined  
Proposed date of entry into force : To be determined   
10. Final date for comments : 60 days after circulation by the WTO secretariat  
11. Texts available from : National enquiry point  [X] or address, telephone and fax 
number s and e mail and website address es, if available , of other body:  
WTO/TBT National Notification and Enquiry Center of the People's Republic of China  
Tel. +86 10 84603950/8460388 9 
Fax: +86 10 84603811  
E_mail : tbt@aqsiq.gov.cn   
https://members.wto.org/crnattachments/2016/TBT/CHN/16_4868_00_x.pdf