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巴西关于修改用于在皮肤上永久性人工染色程序中的注册可植入产品的安全和功效要求

嘉峪检测网        2015-10-03 10:40

通报号: G/TBT/N/BRA/644
ICS号: 87.080
发布日期: 2015-08-26
截至日期: 2015-10-23
通报成员: 巴西
目标和理由: 保护人类安全和健康
内容概述: 技术决议草案No.61,2015年8月17日,关于修改用于在皮肤上永久性人工染色程序中的注册可植入产品的安全和功效要求。 本技术决议草案修订了决议RDC55/2008附录第5部分第5.2项。
正文: 
世界贸易组织
G/TBT/N/BRA/644
2015-08-26
15-4308
 
技术性贸易壁垒
原文:英语
 
通 报


                   以下通报根据TBT协定第10.6条分发

1.
通报成员: 巴西
如可能,列出涉及的地方政府名称 ( 3.2条和7.2 条):
2.
负责机构:巴西卫生监督局–ANVISA
3.
通报依据条款:2.9.2
4.
覆盖的产品: 用于在皮肤上永久性人工染色程序中的可植入产品。
HS编码:32   ICS编码:87.080
5.
通报标题: 技术决议草案No.61,2015年8月17日,关于修改用于在皮肤上永久性人工染色程序中的注册可植入产品的安全和功效要求。

语言:葡萄牙语 页数:3 链接网址:
 
6.
内容简述: 技术决议草案No.61,2015年8月17日,关于修改用于在皮肤上永久性人工染色程序中的注册可植入产品的安全和功效要求。
本技术决议草案修订了决议RDC 55/2008附录第5部分第5.2项。
7.
目标与理由:保护人类健康安全
8.
相关文件: (1)2015年8月18日巴西官方公报第1部分第33页;(2)RDC55/2008;(3)巴西官方公报。(4)未声明。
9.
拟批准日期:评议期结束后决定
拟生效日期:公布之日
10.
意见反馈截止日期: 2015/10/23
11.
文本可从以下机构得到:

正文(英): 

NOTIFICATION

The following notification is being circulated in accordance with Article 10.6

 

1.

Notifying Member: Brazil

If applicable, name of local government involved (Article 3.2 and 7.2):  

2.

Agency responsible: Brazilian Health Surveillance Agency – Anvisa

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:

National Institute of Metrology, Quality and Technology – INMETRO

Telephone: +(55) 21 2563.2840

Telefax: +(55) 21 2563.5637

Email: barreirastecnicas@inmetro.gov.br

Web-site: http://www.inmetro.gov.br/barreirastecnicas

The comments to this Draft Regulation shall be sent to

http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=21796

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 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): Implantable products which are used in procedures of permanent artificial pigmentation on skin.

5.

Title, number of pages and language(s) of the notified document: Draft Technical Resolution no 61, August 17th 2015, regarding the changing of safety and efficacy requirements to registering implantable products which are used in procedures of permanent artificial pigmentation on skin. (3 pages, in Portuguese).

6.

Description of content: Draft Technical Resolution no 61, August 17th 2015, regarding the changing of safety and efficacy requirements to registering implantable products which are used in procedures of permanent artificial pigmentation on skin.

This Draft Technical Resolution modifies the item 5.2 of Part 5 of the Annex of Resolution RDC 55/2008.

7.

Objective and rationale, including the nature of urgent problems where applicable: Protection of Human health or Safety

8.

Relevant documents: 1) Brazilian Official Journal (Diário Oficial da Uni?o), August 18th 2015; Section 1, p. 33; 2) RDC 55/2008; 3) Brazilian Official Journal; 4) Not Stated.

9.

Proposed date of adoption: To be determined after the end of the consultation period.

Proposed date of entry into force: On the date of the publication.

10.

Final date for comments: 23 October 2015

11.

Texts available from: National enquiry point [X] or address, telephone and fax numbers and email and website addresses, if available, of other body:

Agency Responsible

Brazilian Health Surveillance Agency – Anvisa

SIA, Trecho 5, área Especial 57

Brasília – DF/Brazil

CEP: 71.205-050

Phone: +(55) 61 3462.5402

Website: www.anvisa.gov.br

http://portal.anvisa.gov.br/wps/wcm/connect/2d98aa80498640d4bd7ebfda875a0177/CP+61-2015+-+Minuta.pdf?MOD=AJPERES

 

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