Author:
Publisher:
ISBN: 9780644325684
Category : Australia
Languages : en
Pages : 95
Book Description
Requirements for the Supply of Therapeutic Devices Under the Therapeutic Goods Act 1989
Author:
Publisher:
ISBN: 9780644325684
Category : Australia
Languages : en
Pages : 95
Book Description
Publisher:
ISBN: 9780644325684
Category : Australia
Languages : en
Pages : 95
Book Description
Australian Medical Device Requirements
Author: Therapeutic Goods Administration (Australia)
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages :
Book Description
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages :
Book Description
Therapeutic Goods Act 1989
Medical Device Regulations in Asia, Africa and the Middle East,
Author:
Publisher: Global Regulatory Press
ISBN: 1903757010
Category :
Languages : en
Pages : 8
Book Description
Publisher: Global Regulatory Press
ISBN: 1903757010
Category :
Languages : en
Pages : 8
Book Description
Therapeutic Goods Regulations in Force Under the Therapeutic Goods Act 1989
A History of Therapeutic Goods Regulation in Australia
Author: John McEwan
Publisher:
ISBN: 9780980422900
Category : Drugs
Languages : en
Pages : 170
Book Description
Publisher:
ISBN: 9780980422900
Category : Drugs
Languages : en
Pages : 170
Book Description
Medical Device Regulations
Author: Michael Cheng
Publisher: World Health Organization
ISBN: 9241546182
Category : Medical
Languages : en
Pages : 54
Book Description
The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Publisher: World Health Organization
ISBN: 9241546182
Category : Medical
Languages : en
Pages : 54
Book Description
The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Therapeutic Goods Regulations 1990
Author: Australia
Publisher:
ISBN: 9780642419439
Category : Drugs
Languages : en
Pages : 202
Book Description
Publisher:
ISBN: 9780642419439
Category : Drugs
Languages : en
Pages : 202
Book Description
Therapeutic Goods Act 1989
Author: Australia
Publisher:
ISBN: 9780644474122
Category : Capsules (Pharmacy)
Languages : en
Pages : 16
Book Description
Publisher:
ISBN: 9780644474122
Category : Capsules (Pharmacy)
Languages : en
Pages : 16
Book Description
National Statement on Ethical Conduct in Human Research 2023
Author: National Health and Medical Research Council (Australia)
Publisher:
ISBN: 9780648464426
Category : Human rights
Languages : en
Pages : 0
Book Description
"The purpose of the National Statement is to promote ethically good human research. Fulfilment of this purpose requires that participants be accorded the respect and protection that is due to them. It also involves the fostering of research that is of benefit to the community. The National Statement is therefore designed to clarify the responsibilities of: institutions and researchers for the ethical design, conduct and dissemination of results of human research ; and review bodies in the ethics review of research. The National Statement will help them to meet their responsibilities: to identify issues of ethics that arise in the design, review and conduct of human research, to deliberate about those ethical issues, and to justify decisions about them"--Page 6.
Publisher:
ISBN: 9780648464426
Category : Human rights
Languages : en
Pages : 0
Book Description
"The purpose of the National Statement is to promote ethically good human research. Fulfilment of this purpose requires that participants be accorded the respect and protection that is due to them. It also involves the fostering of research that is of benefit to the community. The National Statement is therefore designed to clarify the responsibilities of: institutions and researchers for the ethical design, conduct and dissemination of results of human research ; and review bodies in the ethics review of research. The National Statement will help them to meet their responsibilities: to identify issues of ethics that arise in the design, review and conduct of human research, to deliberate about those ethical issues, and to justify decisions about them"--Page 6.