WORLD TRADE  
ORGANIZATION  G/TBT/W/324 
21 October 2009 
 (09-5213) 
Committee on Technical Barriers to Trade Original:   English 
  
 
TRANSITIONAL REVIEW MECHANISM PURSUANT TO SECTION 18  OF THE 
PROTOCOL ON THE ACCESSION OF THE PEOPLE’S REPUBLIC OF CHINA  
 
Questions and Comments from th e United States to China
 
 
 
 The following communication, dated 20 October 2009, is being circulated at the request of 
the delegation of the United States .  
 
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I. INTRODUCTION 
1. The United States continues to have concerns in  a number of areas that have been addressed 
in recent transitional reviews before this Committ ee, including, for example, favoritism toward home-
grown 3G telecommunications standards, failure to  recognize the results of conformity assessment 
procedures conducted by accredited conformity assess ment bodies, wherever they may be located, 
and the lack of transparency in the development of  technical regulations, standards, and conformity 
assessment procedures.  In connection with this year’s transitional review, the United States would 
like to focus on these areas, as well as proposed Chinese measures relating to medical devices.   
II. CHINA-SPECIFIC TELECOMMUNICATIONS STANDARDS  
2. The United States continues to have significant concerns about China’s use of China-specific 
standards in the telecommunications area, especia lly the WAPI standard.  In 2003, China issued a 
mandatory wireless local area network (WLAN) st andard named GB15629.11 that requires a security 
protocol known as “WLAN authentication and priv acy infrastructure” (WAPI).  Additionally, in 
2003, China issued a measure requiring foreign wireless equipment makers to enter into agreements 
with certain Chinese companies to access a government-classified encryption algorithm needed to 
meet the WAPI standard, effectively forcing foreign equipment makers to transfer technology and 
share proprietary technical information to Chin ese competitors to integrate WAPI into their 
equipment.  In 2004, China agreed to indefinitely su spend the measure mandating the use of WAPI. 
3. In the past several years, global mobile  handset makers have increasingly added 
WLAN/Internet capability into their mobile handset s, expanding the interest in WLAN equipment 
from laptop computers and home computers to mobile  handsets.  The operative standard for this 
expansion of WLAN/Internet capability has been the re levant international standard, i.e., the ISO/IEC 
8802-11 standard, otherwise known as “WiFi.”  To our knowledge no other competing standard is in 
commercial-scale use anywhere in the world.  Howe ver, China has never issued type approvals for 
handsets that connect to the Internet through WLANs , and instead has only issued type approvals for 
handsets that connect to the Internet through cellula r networks.  This has re quired foreign equipment 
makers to disable WLAN/Internet capability before thei r handsets can be marketed in China.  In 2009, 
however, in concert with its plan for encouragi ng an aggressive roll out of third generation (3G) 
mobile handsets by Chinese telecommunications oper ators, many of which are Internet-enabled via 
WLAN networks, China’s Ministry of Industry and Information Technology (MIIT) established a G/TBT/W/324 
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  process for approving hand-held wireless devices such as cell phones and smart phones that are 
Internet-enabled.   MIIT indicated to U.S. governme nt officials in bilateral discussions in September 
2009 that it will approve such devices that use the relevant international standard, i.e., the WiFi 
ISO/IEC 8802-11 standard, only if the devices are also enabled to the WAPI standard.  MIIT officials 
indicated that there is no written or published meas ure providing for this requirement, and China has 
not notified this requirement to the WTO.     
4. Can China explain why it is requiring that mobile handsets be WAPI-enabled, especially 
given that the United States is not aware of any other government that has mandated a particular 
commercial security standard?   
5. Can China further explain why it is mandati ng compliance with a non-consensus based 
standard that does not appear to have been devel oped in an open and transparent process when there is 
a relevant international standard – WiFi – that has been in widespread use in the global marketplace?  
As part of this explanation, please explain why WiFi  would be ineffective or inappropriate to achieve 
China’s objectives?    
6. Given that services and devices based on WiFi alone are now widely available and sold not 
just in the rest of the world but now legally in  China as well, what is China’s justification for 
requiring type approval in this subsector of the mobile equipment market?  
7. What is China’s justification for not mandating these particular technical regulations through 
written and published regulations, in an area as broad as type appr oval and network access for mobile 
devices in the world’s leading mobile handset market?  
III. MEDICAL DEVICE REGISTRATION 
8. In April 2009, China’s State Food and Drug Administration (SFDA) issued for public 
comment a draft Administrative Measures on Medical Device Registration , intended to supersede the 
Administrative Measures on Medical Device Registration  issued in 2004.  However, China has not 
notified this proposal to the WTO.  Would China co nsider notifying the measure to the WTO so as to 
provide a full opportunity for all WTO Members and interested parties to submit comments and agree 
to take these comments and any discussions resulting from them into account?    
9. The United States is also particularly concerned about the proposed requirement in the draft 
Administrative Measures on Medical Device Registration that a medical device must be registered in 
the country of export before it would be accepted for registration in China.  We understand that 
Chinese regulators view such approvals as an a dditional indicator that the device is safe, and 
appreciate China’s objective to en sure that the medical devices used in Chinese hospitals and clinics 
and by Chinese patients achieve the highest levels of safety and efficacy.   
10. We further understand that SFDA is fast-track ing a new notice, independent of the draft 
measure discussed above, that would require a regist rant to produce evidence that it has registered a 
device in its country of legal residence.  For exam ple, any U.S. firm manufacturing anywhere in the 
world would have to obtain a U.S. registration before  registering a device in China.  This requirement 
also raises concerns. 
11. The United States requests that China re-consider both of these domestic registration 
requirements, as either one of them could block access for safe, high-quality medical devices to the Chinese market.  There are many reasons why a manuf acturer may not seek approval of a device in its 
home country or market of export.  For example, a device may be manufactured in a country for export only, or it may be designed specifically for patie nts in a third country, such as China.  In this 
situation, a company would have no business need to seek approval in its home country or the country  G/TBT/W/324 
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  of export and would likely forego that process, wh ich could impose burdens of time and money.  
Thus, the lack of registration in the manufacturer ’s home country or country of export would not 
necessarily be an indication that the device is un safe.  Would China consider making these changes? 
IV. REGULATIONS ON THE RECALL OF DEFECTIVE PRODUCTS 
12. The United States also notes its concern with the draft Administrative Regulations on the 
Recall of Defective Products  issued by the General Administration of Quality Supervision and 
Inspection and Quarantine (AQSIQ), which would appl y to medical devices.  Given that the Ministry 
of Health and SFDA will shortly complete a recall system covering medical devices, begun in 
December 2008 with the publication of an adverse ev ent reporting procedure, and SFDA is the agency 
that regulates medical devices, can China explain why AQSIQ is considering including such devices 
within the scope of the recall procedures it is de veloping?  How would the AQSIQ recall procedures 
add value to the SFDA recall procedures?     
13. In the United States’ view, maintaining du plicative and perhaps contradictory recall 
procedures on medical devices will be highly confusing to me dical device producers.  Not only could 
this disrupt trade, but it could result in a negativ e impact on patient safety by causing delays in the 
reporting and recall process.  SFDA officials also possess product-specific expertise with respect to 
medical devices that will be critical to effectiv e post-market surveillance in the Chinese market.  
Thus, the United States urges AQSIQ to exempt medical devices, just as it has pharmaceuticals from 
the scope of its new recall procedures, and permit  SFDA, which has regulatory authority for medical 
devices and pharmaceuticals in China, to be the so le recall authority for medical devices in the 
Chinese market.  Would China consider making this change? 
V. CONFORMITY ASSESSMENT PROCEDURES 
14. This Committee developed an Indicative List of Approaches to Facilitate Acceptance of the 
Results of Conformity Assessment  (see G/TBT/1/Rev.9, Annexes to Part 1, Section A), which includes 
several approaches for accepting the results of c onformity assessment, including test results 
performed by laboratories located outside the territory of the importing Member.  This list includes 
use of accreditation to ensure the technical comp etence of accredited conformity assessment bodies.  
There are a variety of accreditation approaches, and one approach that has been successfully 
employed by several Members is using accredita tion by International Laboratory Accreditation 
Cooperation (ILAC) Mutual Recognition Arrangement (MRA) members as a basis for accepting test 
results performed by laboratories outside the te rritory of the importing Member.  Has China 
considered utilizing this mechanism – or anot her mechanism such as government designation or 
recognition of foreign testing laboratories – as a basis for accepting test results performed by 
laboratories outside its territory including with r espect to mandatory China Compulsory Certification 
(CCC) Mark or for SFDA requirements?  If not, why not?   
 
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