G/TBT/N/CHN/1186  
 
30 November 2 016 
(16-6567) 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  
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; 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 optically 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 o r 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 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 cameras 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 incorporating 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 sensitized 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), Microscopes other than optical micros copes; 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 included elsewhere in th is Chapter  (HS: 9013), Direction finding 
compasses; other navigational instruments and appliances  (HS: 9014), Surveying (including 
photogrammetrical surveying), hydrographic, oceanographic, hydrological, meteorological or 
geophysical instruments and applia nces, 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 example, drafting machines, 
pantographs, protractors, dra wing 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 use d in medical, surgical, dental or veterinary sciences, including scintigraphic 
apparatus, other electro -medical apparatus and sight -testing instruments  (HS: 9018), G/TBT/N/CHN/1186  
 
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  Mechano -therapy appliances; massage apparatus; psychological 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 implanted in the body, to compensate for a defe ct 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 generator s, 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 floati ng 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, polarimeter s, 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 regulating 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) 
5. Title, number of pages  and language(s)  of the notified document : Regulation on 
Monitoring and Re -evaluation of Medical Device Adverse Event (17 pages, in Chinese)  
6. Description of content : Rules About the Medical Device Adv erse Event Monitoring and 
Re-evaluation Management.  
7. Objective and rationale , including the nature of urgent problems where 
applicable : Protection of human health or safety  
8. Relevant documents : – 
9. Proposed  date of adoption: To be determined  
Propos ed 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 84603950/84603889  
Fax: +86 10 84603811  
E-mail: tbt@aqsiq.gov.cn   
https://members.wto.org/crnattachments/2016/TBT/CHN/16_4912_00_x.pdf