WORLD TRADE  
ORGANIZATION  G/TBT/W/279 
22 October 2007 
 (07-4556) 
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 19 October 2007, is being circulated at the request of 
the delegation of the United States.   
 
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 I. MEDICAL DEVICE BORDER EXAMINATION 
1. China’s Administration of Quality Supervision,  Inspection, and Quarantine (AQSIQ) issued 
the Administrative Measures on Examination and Supervision of Imported Medical Devices  in late 
June 2007, to be effective 1 December 2007.  Known as Decree 95, this measure imposes an 
examination and supervision regime  on imported medical devices.  China cites as underlying statutory 
authority for this measure its 2002 Law on Import and Export Commodity Inspection.  
2. Decree 95 establishes three risk categories of medical devices and three categories for 
importers, based on their experience and other factor s.  It requires certain percentages (ranging from 
10 to 100 percent) of imported medical devices in each risk category to be subject to inspection.  The 
intensity and type of inspection vary based both on  the category of the importer and the risk category 
of the product.   For example, 100 percent of medi cal devices categorized in the highest risk category 
(e.g., MRIs and pacemakers) are s ubject to inspection.  Decree 95 also calls for a product catalogue 
that specifies which medical devices are subject to particular inspection regimes.  These inspections would be in addition to the exis ting certification requirements that foreign manufacturers must obtain, 
prior to exporting medical devices to China, through the normal regulatory process at the State Food 
and Drug Administration and the Certification and A ccreditation Administration.  In addition, Decree 
95 sets out requirements for foreign manufacturers to report product defects, requirements on donated 
medical devices and requirements on remanufactured medical devices.  Decree 95 appears to go substantially further than common international pr actice, where border inspection is generally done 
only on a very small percentage of already-cer tified devices, and done in response to targeted 
concerns. 
3. The United States has serious substantive concer ns about this measure, as well as concerns 
about China’s failure to notify the measure to the WTO.   
(a) Article 23 of Decree 95 provides authority fo r AQSIQ to conduct nine different types 
of inspection at the time a covered pr oduct is imported, including electromagnetic 
compatibility, emissions, and performance asse ssment of diagnostics.  This inspection 
authority, whether it is exercised for 10 per cent, 30 percent, 50 percent or 100 percent 
of imported medical devices (depending on risk categorization and company classification) as indicated in the measure, would mean exhaustive border inspection G/TBT/W/279 
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  in a manner going substantially beyond comm on international practice.  Please clarify 
how frequently AQSIQ and its designees w ill conduct actual inspections of medical 
devices at the point of entry, and how frequently AQSIQ and its designees will 
merely conduct verification of required paperwork. 
(b) Please identify and describe any regulations or  other measures that require inspection 
of domestic medical devices ma nufactured and sold within China, after those medical 
devices have received type approval and SFDA certification.  
(c) Does China have any regulations or other measures that regulate the domestic 
distributors of domestically manufactured medical devices in a manner similar to the scheme set out in Decree 95 for the importers of imported medical devices?  Please 
explain. 
(d) Please describe the fee that will be assessed  when AQSIQ conducts an examination 
and supervision.  How much will an indi vidual examination cost?  What is the 
purpose of the fee and on what basis is it calculated?   
(e) In bilateral discussions with the United States, China has argued, among other things, 
that it sees no need to notify the measure, given that the overarching law (its 2002 
Law on Import and Export Commodity Inspection) was notified to the WTO.  However, the TBT Agreement notification oblig ation applies to any measure that fits 
the definition of a technical regulation unde r Annex 1 of the Agreement, subject to 
the provisions of Article 2.9.  Thus, a WTO Member’s characterization of a measure as a law, a regulation or some other type of  measure is not determinative.  The United 
States routinely notifies to the WTO chang es made by not only laws enacted by the 
U.S. Congress, but also regulations and other measures issued by regulatory agencies.  Please explain China’s justification for not notifying Decree 95 to the WTO. 
(f) China has also argued that notification of Decree 95 is not required because this 
measure does not impose any requirements on foreign manufacturers, and only 
impacts domestic Chinese entities involved in importation. By its terms, the measure 
requires the examination of imported medical devices, based on a scale from low-risk to high-risk medical devices.  The measure also requires foreign manufacturers to report defects, and imposes penalties in the form of increased examinations of imported devices based on product returns or quality complaints.  The measure 
additionally regulates medical devices imported for research purposes, as well as used 
medical devices, and provides authority to AQSIQ to stop the import of defective 
medical devices based on reporting from a risk alert system.  The underlying law on which this measure is based, the Law on Import and Export Commodity Inspection, is 
focused on the inspection of import and export commodities.  Given these facts, please explain China’s position that this measure does not impose any requirements 
on foreign manufacturers, and only impacts domestic Chinese entities involved in 
importation.  
(g) Will China notify Decree 95 to the WTO and permit WTO Members and interested 
persons the opportunity to present comments in writing, and for China to hear the 
concerns of Members and interested persons  and make appropriate modifications to 
the regulations, and for China to allow e xporters time to adapt their products and 
export procedures to China’s requirement s?  Given the short time before the 
measure’s effective date, will China consider  suspending the measure, including its 1 
December 2007, effective date, so that this process can take place?  G/TBT/W/279 
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  II. BATTERY STANDARDS 
4. China’s Ministry of Information Industry (MII) is developing a standard that would specify 
requirements for the size, electrical performance, safety performance, and labeling of mobile phone 
batteries (“Specification for General lithium batte ries of Mobile Telecommunication Terminal 
Equipment,” YD/T xxxx-xxxx).  MII justifies the need for this standard on the grounds of consumer 
convenience, development of the mobile phone industr y and environmental and sa fety concerns.  U.S. 
and foreign mobile handset makers ma intain that compliance with this standard will, in fact, have the 
opposite effect in each of the areas identified by MII.  The United States is concerned that the 
standard, which does not appear to have been de veloped in accordance with the principles contained 
in the relevant WTO TBT Committee decision (G/T BT/1/Rev.8, section IX, 23 May 2002), will be 
integrated into a technical regulation, such as MII or National Certification and Accreditation 
Administration certification and type approval schem es, thereby making compliance with the standard 
mandatory.  Further, the United States is concerne d that China may not notify the proposed technical 
regulation to the WTO.    
(a) Please explain the purpose of this standard. 
(b) Is this standard based on any inte rnational standard?  Please explain. 
(c) How will conformity assessment with resp ect to this standard be conducted? 
(d) Please explain how MII’s development of this standard has met each of the six 
criteria contained in the relevant WTO TBT Committee decision (G/TBT/1/Rev.8, section IX, 23 May 2002): (a) transparency, (b) openness, (c) impartiality and consensus, (d) effectiveness and relevance, (e) coherence,  and (f) development).    
(e) When does China anticipate the draft battery standard will be finalized? 
(f) Can China confirm that demonstrating comp liance with the battery standard will not 
be a requirement for mobile phone manufacturers or battery manufacturers to obtain type approval, CCC mark registration or othe r approval before selling their products 
in China? 
(g) If the battery standard will be a requirement for mobile phone manufacturers or 
battery manufacturers to obtain MII type approval, CCC mark registration or other 
approval before selling their products in China, will China notify the WTO of the change in MII type approval rules, CCC mark rules or other approval rules, and provide an opportunity for interested parties including governments and industry representatives to comment on that change, before it takes effect? 
III. ADMINISTRATION ON THE CONTROL OF POLLUTION CAUSED BY 
ELECTRONIC INFORMATION PRODUCTS  
5. The United States continues to have concerns about China’s Administrative Measures on the 
Control of Pollution Caused by Electronic Information Products , issued by several Chinese agencies 
effective 1 March 2007 (notified in G/TBT/N/CHN/140) .  Specifically, China has neither issued the 
catalogue of products for which mandatory testing will be required under this  measure, nor provided 
any details on the testing and certification protocols,  which China has indicated will be forthcoming.   
(a) Please provide an update on when the product catalogue for products requiring 
certification under this measure will be issued.    G/TBT/W/279 
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  (b) Please reconfirm that the product catalogue will be notified to the WTO and that 
China will allow a reasonable interval be tween the publication of the final product 
catalogue and its entry into force.  
(c) Please provide a list of all laboratories that are currently accredited to perform 
hazardous substance testing for China.  How many more laboratories does China 
anticipate accrediting?  How quickly will this accreditation process be completed? 
(d) Will China accredit laboratories physically lo cated in China that are wholly-foreign 
owned facilities or majority-foreign owned facilities?  If not, why not? 
(e) Will China accredit certification bodies located  in other countries or recognize 
certification bodies in other countries which have been accredited by other 
accreditation bodies?  If not, why not? 
(f) Please provide information on the status of th e testing standards that will be used for 
certification of products contained in the product catalogue.  We understand that 
China has published testing standards that ar e based on draft IEC standards.  In the 
event that the current draft IEC standards are revised, will China promptly amend its 
testing standards? 
(g) Will China institute a system for Supp lier’s Declaration of Conformity for 
compliance with these measures? 
IV. TRANSPARENCY 
6. The United States appreciates China’s efforts to improve transparency within its regulatory 
system.  However, a significant number of technical regulations conti nue to be introduced or amended 
without the advance notification required by the TBT Agreement.  This is particularly the case for 
regulations issued by agencies other than AQSIQ an d its sub-unit, the Standardization Administration 
of China (SAC).  In addition, even when inform ation is available on new regulations or regulatory 
proposals, the opportunity for foreign stakeholders to  comment is either lim ited or does not exist at 
all. 
7. The chart below provides a breakdown of notifications by agency.   
 
    
 
    
  
  China TBT Notifications:  2002 - present
124 1 22211
34
27
050100150200250
SAC AQSIQ CNCA MOH MII SFDA SEPA Other G/TBT/W/279 
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  8. The United States urges China to notify the TBT Committee of all draft technical regulations 
and conformity assessment procedures that may affect  trade.  The United States also urges China to 
provide a reasonable period for comment and a reas onable interval between publication and entry into 
force.  
(a) Please describe any steps that China has ta ken during the past year to improve its 
record with regard to TBT Agreement notifications.  
(b) Please describe any steps that China has ta ken during the past year to institute 
improvements with regard to notice-and- comment procedures for draft technical 
regulations and conformity assessment procedures. 
V. INTERNATIONAL STANDARDS 
9. As explained in connection with prior transiti onal reviews before this  Committee, the United 
States remains concerned that China may be unnecessar ily restricting itself to the use of standards 
from certain identified bodies, as the implementa tion documents associated with China’s Law on 
Standards limit its definition of “international sta ndards” to standards issued  by the International 
Organization for Standardization (ISO), Inte rnational Electrotechnical Commission (IEC), 
International Telecommunication Union (ITU) and ot her international organizations recognized and 
publicized by ISO.  The United States appreciate s the explanations that China has previously 
provided.  Nevertheless, the United States recalls that the TBT Committee has agreed upon a Decision 
containing principles for international standard s (G/TBT/1/Rev.8, IX) to assist Members in 
implementing relevant obligations under the TBT Agre ement.  In considering future amendments to 
its Law on Standards and/or implem enting measures, the United States encourages China to take these 
principles into consideration.  At the same time , the United States welcomes the serious efforts that 
China has made to contribute to the development of  standards from a broader range of bodies, and the 
United States welcomes China’s utilization of these st andards in its domestic regulatory system.  The 
United States encourages China to continue to c onsider the use of these standards from a broader 
range of bodies when appropriate for domestic purpo ses, while continuing to take into consideration 
the principles of G/TBT/1/Rev.8, IX. 
VI. CONFORMITY ASSESSMENT PROCEDURES 
10. During last year’s transitional review before  this Committee, when addressing the China 
Compulsory Certification (CCC) system, China again noted that it had been studying the possibility of 
adopting different conformity assessment procedures,  including Supplier’s Declaration of Conformity. 
Can China provide an update of its review and e xplain whether it has taken any concrete steps to 
adopt different conformity assessment procedures? 
 
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