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Medical Devices Regulation

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Series Essential Drugs and Technology 17 Consultation on Regulation of Medical Devices Series Essential Drugs and Technology 17 Consultation on Regulation of Medical Devices

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Date added: 11/30/1998
Date modified: 09/10/2010
Filesize: Unknown
Downloads: 632

Autor Corporativo: PAHO

Autor(es): PAHO

24,p.

To revise the reference documents. A Guideline for the Regulation of Medical Devices and A model Program for Medical Devices. To present an overview of the programs and topics of regulation of the Collaborating Centers of WHO/PAHO in medical devices. Exchange information on high-priority topics on legislation of medical devices.

Proceedings of the Seminar and Advisory Group on Regulatory Policies for Medical Devices 2-10 May 1990. Proceedings of the Seminar and Advisory Group on Regulatory Policies for Medical Devices 2-10 May 1990.

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Date added: 09/01/2010
Date modified: 09/01/2010
Filesize: Unknown
Downloads: 506

Autor(es): Bureau of Radiation and Medical Devices Canada, Center for Devices and Radiological Health USA.

65,p. 

Regulation of the sale of medical devices in a country has been shown to reduce the problems, often serious, from inadequate and defective equipment. More countries are now taking an interest in such regulation as health cost escalates and more sophisticated devices are used in diagnosis and treatment. This seminar was designed to introduce Latin American and Caribbean health officials to Canadian, U.S., and European experiences with the regulation of medical devices and to develop recommendations for regulations in the participating countries.

Proceedings of the First International Conference of Medical Device Regulatory Authorities (ICMDRA) Proceedings of the First International Conference of Medical Device Regulatory Authorities (ICMDRA)

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Date added: 11/30/1985
Date modified: 11/02/2009
Filesize: Unknown
Downloads: 589

Autor Corporativo: PAHO, FDA

Autor(es): PAHO, FDA

284,p.

"Innovation in medical device technology has complicated and profoundly affected modern health care. The rapid proliferation of new and exciting medical device technologies, holding the promise of great potential health benefit, confronts health priorities and allocate scare resources. The burden of decision is rendered more difficult by the number and complexity of the questions that must be considered and factored into the decision-making process.

International Workshop on the Regulation of Medical Devices. Andean Region. Final Report International Workshop on the Regulation of Medical Devices. Andean Region. Final Report

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Date added: 11/30/2000
Date modified: 11/02/2009
Filesize: Unknown
Downloads: 637

Autor Corporativo: PAHO

Autor(es): Dra. Nancy Fernández, Dra. María Isabel Schotborgh, Ing. Napoleon Ortiz, Q.F. Claudia Elizabeth Mora, Ing. Luis Vilcahuaman, Dra. Elizabeth Garrido, Dra. María Cristina de la Torre

17,p.

"Address the interests and needs of the Andean Community in the areas of regulation, surveillance, and harmonization of medical devices by taking advantage of the progress made in other countries of the Americas

A model Regulatory Program for Medical Devices: An International Guide A model Regulatory Program for Medical Devices: An International Guide

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Date added: 11/30/2000
Date modified: 11/02/2009
Filesize: Unknown
Downloads: 780

Autor Corporativo: PAHO

Autor(es): Robert C. Eccleston, Editor Antonio Hernández

82,p.

"With each passing year, advancements in medical technology make it increasingly imperative for governments to promulgate laws and regulations or undertake other public health measures to ensure that maximal benefits are derived from their use while risks to patients are kept to a minimum.

A Guide for the Development of Medical Device Regulations A Guide for the Development of Medical Device Regulations

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Date added: 11/30/2001
Date modified: 11/02/2009
Filesize: Unknown
Downloads: 663

Autor Corporativo: PAHO, Medical Devices Bureau, Therapeutic Products Directorate, Health Products and Foods Branch, Health Canada

Autor(es): Michael Cheng, Editor Ing. Antonio Hernández

66,p.

A guideline for the Member Sates seeking to develop a program to ensure the safety and effectiveness of medical devices. This work is mainly based on existing documentation. A summary of the key recommendations for establishing an affordable program to manage medical devices

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