G/TBT/N/CHN/1184  
 
28 November 2016  
(16-6509) Page: 1/3 
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 (CFDA ) 
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 . 
Optical fibres and optical fibre bundles; o ptical fibre cables other than those of heading 
85.44; sheets and plates of polarising material; lenses (including contact lenses), prisms, 
mirrors and other optical elements, of any material, unmounted, other than such elements of 
glass not opti cally work ed (HS: 9001), Lenses, prisms, mirrors and other optical elements, of 
any material, mounted, being parts of or fittings for instruments or apparatus, other than 
such element s of glass not optically worked  (HS: 9002), Frames and mountings for 
spectacles, go ggles or the like, and parts thereof  (HS: 9003), Spectacles, goggles and the 
like, corrective, protective or other  (HS: 9004), Binoculars, monoculars, other optical 
telescopes, and mountings therefor; other astronomical instruments and mountings therefor, 
but not including i nstruments for radio - Astronomy  (HS: 9005), Photographic (other than 
cinematographic) cameras; photographic flashlight apparatus and flashbulbs other than 
discharge lamps of heading 85.39  (HS: 9006), Cinematographic cameras and projector s, 
whether or not incorporating sound rec ording or reproducing apparatus  (HS: 9007), Image 
projectors, other than cinematographic; photographic (other than cinematographic) 
enlargers and reducers. ( HS: 9008), Photocopying apparatus incorporating an optical  system 
or of the contact ty pe and thermo -copying apparatus  (HS: 9009), Apparatus and equipment 
for photographic (including cinematographic) laboratories (including apparatus for the 
projection or drawing of circuit patterns on sensitized semiconductor mat erials), not specified 
or included elsewhere in this Chapter; n egatoscopes; projection screens  (HS: 9010), 
Compound optical microscopes, including those for photomicrography, cinephot omicrography 
or microprojection  (HS: 9011), Microscopes other than optica l mic roscopes; diffraction 
apparatus  (HS: 9012), Liquid crystal devices not constituting articles provided for more 
specifically in other headings; lasers, other than laser diodes; other optical appliances and 
instruments, not specified or include d elsewhe re in this Chapter  (HS: 9013), Direction finding 
compasses; other navigati onal instruments and appliances  (HS: 9014), Surveying (including 
photogrammetrical surveying), hydrographic, oceanographic, hydrological, meteorological or 
geophysical instruments an d appliances, ex cluding compasses; rangefinders  (HS: 9015), 
Balances of a sensitivity of 5 cg or better, with or without weights  (HS: 9016), Drawing, 
marking -out or mathematical calculating instruments (for example, drafting machines, 
pantographs, protract ors, drawing sets, slide rules, disc calculators); instruments for 
measuring length, for use in the hand (for example, measuring rods and tapes, micrometers, 
callipers), not specified or inc luded elsewhere in this Chapter  (HS: 9017), Instruments and 
applia nces used in medical, surgical, dental or veterinary sciences, including scintigraphic G/TBT/N/CHN/1184  
 
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  apparatus, other electro -medical apparatu s and sight -testing instruments  (HS: 9018), 
Mechano -therapy appliances; massage apparatus; psychological aptitude -testing appara tus; 
ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other th erapeutic 
respiration apparatus  (HS: 9019), Other breathing appliances and gas masks, excluding 
protective masks having neither mechanical parts nor replaceable  filters  (HS: 9020), 
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 compen sate fo r 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 g enerators, high tension generators, 
control panels and desks, screens, examination or treatm ent tables, chairs and the like  
(HS: 9022), Instruments, apparatus and models, designed for demonstrational purposes (for 
example, in education or exhibiti ons), uns uitable for other uses  (HS: 9023), Machines and 
appliances for testing the hardness, strength, compressibility, elasticity or other mechanical 
properties of materials (for example, metals, w ood, textiles, paper, plastics)  (HS: 9024), 
Hydrometers and simila r floating instruments, thermometers, pyrometers, barometers, 
hygrometers and psychrometers, recording or not, and any c ombination of these 
instruments  (HS: 9025), Instruments and apparatus for measuring or checking the flow, 
level, pressure or other varia bles of liquids or gases (for example, flowmeters, level gauges, 
manometers, heat meters), excluding instruments and apparatus of headi ng 90.14, 90.15, 
90.28 or 90.32  (HS: 9026), Instruments and apparatus for physical or chemical analysis (for 
example, pol arimeters, 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 h eat, 
sound or light (includi ng exposure meters); microtomes  (HS: 9027), Gas, liquid or electricity 
supply or production meters, includ ing calibrating meters therefor  (HS: 9028), Revolution 
counters, production counters, taximeters, mileometers, pedometers and the like; speed 
indicators and tachometers, other than those of headi ng 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, cosm ic 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 regulating or contro lling instruments and apparatus  (HS: 9032), Parts and 
accessories (not specified or included elsewhere in this Chapter) for machines, appliances, 
instrum ents or apparatus of Chapter 90  (HS: 9033). Health care technology (ICS: 11) 
5. Title, number of pages  and language(s)  of the notified document : Provision for 
Classification Adjustment of Allergen and other Three Kinds of In -vitro Diagnostic Reagents 
(28 pages, in Chinese)   
6. Description of co ntent : According to the actual requirements of registration management 
of IVD, it adjusts the classification of so me kinds of allergen reagents, 
immunoh istochemical reagents, and the r eagents match up the flow cytometry.  
7. Objective and rationale , includ ing 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 Secretarial  G/TBT/N/CHN/118 4 
 
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  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 Peop le's Republic of Chian  
Tel.:+86 10 84603950/84603889  
Fax:+86 10 84603811  
Email : tbt@aqsiq.gov.cn   
https://members.wto.org/crnattachm ents/2016/TBT/CHN/16_4869_00_x.pdf   
https://members.wto.org/crnattachments/2016/TBT/CHN/16_4869_01_x.pdf