附註:"Prepared under the principle authorship of Dr Michael Cheng"--Title page verso
Includes bibliographical references (pages 37-39).
Foreword; Glossary; Chapter 1. Introduction; Chapter 2. Medical device safety; Chapter 3. Governmental regulation of medical devices; Chapter 4. Global Harmonization Task Force (GHTF); Chapter 5. Standards; Chapter 6. Optimizing the use of regulatory resources; Chapter 7. Priorities on the international agenda; Annex 1. Resources for medical device information; Annex 2. Final documents of the GHTF as they relate to the Common Regulatory Framework; Annex 3. Relationship between ISO9001:1994 and ISO13485:1996; Annex 4. Aide-mémoire for National Medical Device Administrations.
摘要:Medical devices and equipment are a vital component of patient care. From a simple tongue depressor to a sophisticated haemodialysis machine, medical devices are needed at every level of the health service. Yet many health services continue to lack information and financial resources to acquire the devices they really need, i.e. those that will address the specific disease burden in their country. Effective implementation of a National Regulatory Authority is a first step towards the cost-effective management of medical devices that meet international quality and safety standards, throughout t.
