Medical Devices Regulation

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.

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

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.

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

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.

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.