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20240329122006.0 |
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|a EBLCP
|b eng
|c EBLCP
|d OCLCO
|d REDDC
|d OCLCO
|d OCLCQ
|d K6U
|d OCLCF
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|a 9789275325544
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|a 9275325545
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|a (OCoLC)1378389813
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|a RA776
|b .P363 2022
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|a 658
|2 23
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|a UAMI
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| 100 |
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|a Organization, Pan American Health.
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|a Modelo Mundial de Marco Regulatorio de la OMS para Dispositivos Médicos, Incluidos Los Dispositivos Médicos de Diagnóstico 'in Vitro'
|h [electronic resource].
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| 260 |
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|a London :
|b Pan American Health Organization (PAHO),
|c 2022.
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| 300 |
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|a 1 online resource (76 p.)
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| 500 |
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|a Description based upon print version of record.
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|a Intro -- Acronyms and abbreviations -- Acknowledgements -- 1 Introduction -- 1.1 The WHO Global Model Regulatory Framework for Medical Devices including IVDs -- 1.2 Limitations of the WHO Global Model Regulatory Framework for Medical Devices including IVDs -- 2. Definition, classification, essential principles and conformity assessment of medical devices -- 2.1 Definition of medical device and IVD -- 2.2 Medical devices classification and classification rules -- 2.3 Essential principles of safety and performance -- 2.3.1 Clinical evidence for non-IVDs
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|a 2.3.2 Assessing conformity to the Essential Principles -- 2.4 Special considerations for regulation of IVDs -- 2.4.1 Classification of IVDs -- 2.4.2 Essential Principles of safety and performance for IVDs -- 2.4.3 Clinical evidence for IVDs -- 2.4.4 Lot verification testing of IVDs -- 3. Enabling conditions for effective regulation of medical devices -- 3.1 Legal requirements -- 3.2 Gap analysis of existing controls -- 3.3 Implementation plan -- 3.4 Monitoring implementation -- 3.5 Regulatory authority -- 3.6 Funding the regulatory system -- 3.7 Conflict of interest and impartiality
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|a 3.8 Regulatory competencies and resources -- 4. Establishing a stepwise approach to regulating medical devices -- 4.1 Stepwise approach -- 4.1.1 Reliance and recognition -- 4.1.1.1 National responsibilities -- 4.1.1.2 International collaboration -- 4.2 Basic-level controls and their enforcement -- 4.2.1 Publish law, including definition, and regulations with transition period -- 4.2.1.1 Establish medical device classification for regulatory purposes -- 4.2.1.2 Establish Essential Principles of safety and performance -- 4.2.2 Basic-level controls and enforcement -- premarket
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|a 4.2.2.1 Establish a basis for reliance and recognition -- 4.2.2.2 Establish requirements for declaration of conformity -- 4.2.2.3 Establish requirement for manufacturers to have a QMS -- 4.2.2.4 Establish requirements for labels and labelling -- 4.2.2.5 Prohibit deceptive, misleading and false advertising -- 4.2.2.6 Establish provisions for exceptional premarket situations -- 4.2.3 Basic-level controls and enforcement -- placing on the market -- 4.2.3.1 Registration of establishments -- 4.2.3.2 Listing of medical devices -- 4.2.3.3 Import controls -- 4.2.4 Basic-level controls -- postmarket
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|a 4.2.4.1 Establish a system for vigilance reporting -- 4.2.4.2 Require mandatory notification by the manufacturer of FSCA -- 4.2.4.3 Establish a procedure to withdraw unsafe medical devices from the market -- 4.2.4.4 Establish procedure to issue safety alerts to users -- 4.2.4.5 Undertake market surveillance -- 4.3 Expanded-level controls -- 4.3.1 Expanded-level controls -- premarket -- 4.3.1.1 Create oversight of clinical investigations -- 4.3.1.2 Appoint and have oversight of CAB -- 4.3.1.3 Recognition of standards -- 4.3.1.4 Adopt a medical device nomenclature system
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| 500 |
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|a 4.3.1.5 Control advertising and promotion
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| 590 |
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|a ProQuest Ebook Central
|b Ebook Central Academic Complete
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| 650 |
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0 |
|a Health.
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| 650 |
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2 |
|a Health
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| 650 |
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6 |
|a Santé.
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| 650 |
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7 |
|a health.
|2 aat
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| 650 |
|
7 |
|a Health.
|2 fast
|0 (OCoLC)fst00952743
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| 655 |
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4 |
|a Spanish language materials.
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| 776 |
0 |
8 |
|i Print version:
|a Organization, Pan American Health
|t Modelo Mundial de Marco Regulatorio de la OMS para Dispositivos Médicos, Incluidos Los Dispositivos Médicos de Diagnóstico 'in Vitro'
|d London : Pan American Health Organization (PAHO),c2022
|z 9789275325551
|
| 856 |
4 |
0 |
|u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=30507989
|z Texto completo
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| 938 |
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|a ProQuest Ebook Central
|b EBLB
|n EBL30507989
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| 994 |
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|a 92
|b IZTAP
|
