G/TBT/N/CHN/1024/Rev.1  
 
30 November 2016  
(16-6568) Page: 1/3 
Committee on Technical Barriers to Trade  Original: English  
 
  NOTIFICATION  
Revision  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member : CHINA  
If applicable, name of local government involved (Articles 3.2 and 7.2) : 
2. Agency responsible:  China Food and Drug Administr ation(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 fibr e bundles; optical 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 op tically worked. ( 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 elements of glass not optically worked. ( HS: 9002), Frames 
and mountings for spectacles, goggles 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 moun tings therefor, but not including instruments 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 cam eras and projectors, whether or not incorporating sound recording or 
reproducing apparatus. ( HS: 9007), Image projectors, other than cinematographic; 
photographic (other than cinematographic) enlargers and reducers. ( HS: 9008), 
Photocopying apparatus incor porating an optical system or of the contact type 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 sensitiz ed semiconductor materials), not specified or included 
elsewhere in this Chapter; negatoscopes; projection screens. ( HS: 9010), Compound 
optical microscopes, including those for photomicrography, cinephotomicrography or 
microprojection. ( HS: 9011), Microsc opes other than optical microscopes; 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 specif ied or included elsewhere in this Chapter. ( HS: 9013), Direction 
finding compasses; other navigational instruments and appliances. ( HS: 9014), Surveying 
(including photogrammetrical surveying), hydrographic, oceanographic, hydrological, 
meteorological or g eophysical instruments and appliances, excluding 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 G/TBT/N/CHN/1024/Rev.1  
 
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  example, drafting mach ines, pantographs, protractors, 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 included elsewhere in 
this Chapter. ( HS: 9017), Instruments and appliances used in medical, surgical, dental or 
veterinary sciences, including scintigraphic apparatus, other electro -medical apparatus and 
sight-testing instruments. ( HS: 9018), Mechano -therapy appliances; massage apparatus; 
psycholo gical aptitude -testing apparatus; ozone therapy, oxygen therapy, aerosol therapy, 
artificial respiration or other therapeutic 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 implante d 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 apparatu s, X-ray tubes and other 
X-ray generators, high tension generators, control panels and 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 o r 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 counter s, 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 ele ctrical 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 specifie d or included elsewhere in this 
Chapter; profile projectors. ( HS: 9031), Automatic regulating or controlling instruments 
and apparatus. ( HS: 9032), Parts and accessories (not specified or included elsewhere in 
this Chapter) for machines, appliances, instru ments or apparatus of Chapter 90. 
(HS: 9033) . Health care technology (ICS: 11) 
5. Title, number of pages and language(s) of the notified document : Provisions for In -
vitro Diagnostic Reagent Registration Amendment (1 page, in Chinese)  
6. Description of co ntent : In the Supple mentary Articles of these Provisions, a new article 
"the classification principle defined by t he 17th and 18th articles of the se provisions can be 
amended by China Food and Drug Administration according to the actual conditions"  is 
proposed to be added.  
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  G/TBT/N/CHN/1024/Rev.1  
 
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  10. Final date for comments : 60 days after circulation by the WTO Secretaria t 
11. Texts available from : National enquiry point  [X] or address, telephone or fax 
number s and  email and website address es, if available , of other body : 
WTO/TBT N ational Notification and Enquiry Center of the People's Republic of Chiana  
Tel: +86 10 84603950/84603889  
Fax: +86 10 84603811  
Email : tbt@aqsiq.gov.cn   
https://members.wto.org/crnattachments/2016/TBT/CHN/16_4914_00_x.pdf