| 通報(bào)號(hào): G/TBT/N/USA/1200 |
ICS號(hào): 11.040
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發(fā)布日期: 2016-09-28
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截至日期: 2016-09-28
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通報(bào)成員: 美國(guó)
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目標(biāo)和理由: 保護(hù)人類安全和健康
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內(nèi)容概述: 食品藥品管理局（FDA）現(xiàn)將磁療儀系統(tǒng)分到II類（特別管控）。適用于該類設(shè)備的特別管控在本法令中確定，將成為磁療儀系統(tǒng)分類編纂語言的一部分。FDA現(xiàn)將此類設(shè)備歸為II類（特別管控），以便為此類設(shè)備的安全和功效提供合理的保證。
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正文:
| 世界貿(mào)易組織 |
G/TBT/N/USA/1200
2016-09-28
16-5182
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| 技術(shù)性貿(mào)易壁壘 |
原文：英語
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通 報(bào)
以下通報(bào)根據(jù)TBT協(xié)定第10.6條分發(fā)
| 1. |
通報(bào)成員: 美國(guó)
如可能，列出涉及的地方政府名稱 ( 3.2條和7.2 條)：
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| 2. |
負(fù)責(zé)機(jī)構(gòu)：衛(wèi)生及公共服務(wù)部(HHS)食品藥品管理局(FDA) [1218]
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| 3. |
通報(bào)依據(jù)條款：
[ ] 2.9.2
[ ] 2.10.1
[ ] 5.6.2
[ ] 5.7.1
通報(bào)依據(jù)的條款其他： X
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| 4. |
覆蓋的產(chǎn)品： 磁療儀系統(tǒng)。醫(yī)療設(shè)備。 ICS: 11.040 HS:
HS編碼：9018,9022 ICS編碼：11.040
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| 5. |
通報(bào)標(biāo)題： 醫(yī)療設(shè)備；一般和整形外科設(shè)備；磁療儀系統(tǒng)分類。
語言：英語 頁數(shù)：3 鏈接網(wǎng)址：
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| 6. |
內(nèi)容簡(jiǎn)述： 食品藥品管理局（FDA）現(xiàn)將磁療儀系統(tǒng)分到II類（特別管控）。適用于該類設(shè)備的特別管控在本法令中確定，將成為磁療儀系統(tǒng)分類編纂語言的一部分。FDA現(xiàn)將此類設(shè)備歸為II類（特別管控），以便為此類設(shè)備的安全和功效提供合理的保證。
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| 7. |
目標(biāo)與理由：保護(hù)人類健康安全。
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| 8. |
相關(guān)文件： 2016年9月21日聯(lián)邦紀(jì)事（FR）第81卷第64761頁；聯(lián)邦法規(guī)法典（CFR）第21編第878部分。
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| 9. |
擬批準(zhǔn)日期：2016/06/13
擬生效日期：2016/09/21
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| 10. |
意見反饋截止日期： 無
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| 11. |
文本可從以下機(jī)構(gòu)得到：
[ ] 國(guó)家通報(bào)機(jī)構(gòu)
[ ] 國(guó)家咨詢點(diǎn)，或其他機(jī)構(gòu)的聯(lián)系地址、傳真及電子郵件地址(如能提供):
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正文(英):
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6
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1.
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Notifying Member: United States of America
If applicable, name of local government involved (Article 3.2 and 7.2):
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2.
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Agency responsible: Food and Drug Administration (FDA), Health and Human Services (HHS) [1218]
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:
Please submit comments to: USA WTO TBT Enquiry Point
Email: usatbtep@nist.gov
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3.
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Notified under Article 2.9.2 [ ], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other: X
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4.
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Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Magnetic surgical instrument systems. Medical equipment (ICS: 11.040)
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5.
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Title, number of pages and language(s) of the notified document: Medical Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System (3 pages, in English)
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6.
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Description of content: The Food and Drug Administration (FDA) is classifying the Magnetic Surgical Instrument System into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the magnetic surgical instrument system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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7.
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Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety
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8.
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Relevant documents: 81 Federal Register (FR) 64761, 21 September 2016; Title 21 Code of Federal Regulations (CFR) Part 878
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9.
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Proposed date of adoption: 13 June 2016
Proposed date of entry into force: 21 September 2016
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10.
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Final date for comments: None
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11.
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Texts available from: National enquiry point [ ] or address, telephone and fax numbers and email and website addresses, if available, of other body:
https://members.wto.org/crnattachments/2016/TBT/USA/16_4031_00_e.pdf
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