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巴西医疗器械适用法规下载

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RA小编辑
发表于 2020-5-9 14:05:37 | 显示全部楼层 |阅读模式

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本文转载自Emergogroup


Brazil ANVISA Medical Device Regulations



All documents listed below were published by ANVISA in Portuguese and translated by Emergo into English. Use the English for informational purposes only.



Major Regulations[td]
Document
Language
Number
Published
Classification and Registration Requirements of Medical Productsen ptRDC 185/20012001
GMP Requirements for Medical Devices and IVDsen ptRDC 16/201303/2013
Requirements for Economic Information Report (EN)en ptRDC 185/20062006
Requirements for Proof of GMP for registration processes of healthcare products (EN)en ptRDC 15/20142014
General Guidance Documents[td]
Document
Language
Number
Published
Administrative Procedures for GMPen ptRDC 39/20132013
Changes Law 9782-1999 GMPen ptLEI 11.972/20092009
Consumer Protection Codeen ptLEI 8.078/19901990
DECRETO - Health Surveillanceen pt8077/20132013
Health Surveillance Standardsen ptLEI 6.360/19761976
Mandatory Certification of Equipmenten ptRDC 27/20112011
Safety and Efficacy Requirementsen ptRDC 56/20012001
Sanitary Violations and Sanctionsen ptLEI 6.437/19771977
Specific Guidance Documents[td]
Document
Language
Number
Published
List of Products Requiring Economic Information Reporten ptRE 3385/20062006
Cadastro Registration Requirements of Medical Devicesen ptRDC 40/201508/2015
Cadastro registration of IVDsen ptRDC 36/201527 August 2015
Changes RDC 206/2006 regarding IVDsen ptRDC 34/20122012
General Requirements for Product Certificationen pt118/201603/2016
Import of Products for Fairs and Eventsen ptRDC 13/20042004
Inmetro Certification - Registrations issued After 1 February 2016en pt54/201602/2016
Inmetro Certification - Registrations issued prior to 31 January 2016en pt350/20102010
Labeling information for devices with natural rubber latex componentsen ptRDC 37/201527 August 2015
List of GMP Provisions for Importers Distributors and Storage Companies (EN)en ptIN 08/20132013
List of Products Prohibited to be ReprocessedenRE 2605/20062006
On registration of IVD familiesen ptIN 03/201526 August 2015
Requirements for Electronic IFUen ptIN 04/20122012
Technovigilance Requirements for Registration Holdersen ptRDC 67/20092009
Transfer regulationenRDC 102/201608/2016
Used and Refurbished Productsen ptRDC 25/20012001
Additional Information[td]
Document
Language
Number
Published
Chronological Criteria for Registration Application Reviewsen ptRDC 3/20102010
Field Action Requirementsen ptRDC 23/20122012
List of Products Not Deemed as Healthcare Productsen ptVersion 508/2016
National Sanitary Surveillance System and National Health Surveillance Agency CreationptLEI 9782/19991999
Technical Note - Concept of Legal Manufactureren pt001/200905/2009
Technical Note - GGTPS Submission of GMP Applicationen pt002/20092009
Technical Note 004/2016 - Clinical Trial Requirements and Guidelines for Registro and Cadastro productsen pt004/201611/2016





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注册人士
发表于 2020-10-12 11:47:30 | 显示全部楼层
楼主，请问方便告诉转载的Emergogroup文章地址吗？想学习
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RA小编辑
 楼主| 发表于 2020-10-13 10:41:02 | 显示全部楼层
注册人士 发表于 2020-10-12 11:47
楼主，请问方便告诉转载的Emergogroup文章地址吗？想学习

从Emergogroup的官网搜索巴西区域就可以找到的
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