HTA is multi-disciplinary field of policy analysis that examines the medical, economic, social and ethical implications of the incremental value, diffusion and use of a health technology in health care.
The term Health Technology refers to application of organised knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of life.
Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context
The purpose of this interagency publication is to provide harmonized product specifications for a wide range of products for delivering basic oxygen therapy, and to provide guidance on the selection, procurement, use and maintenance of these products. The specifications and technical guidance are intended to support health facility administrators, clinical decision-makers, procurement officers, planning officers, biomedical […]
Objectives: Current health technology assessment (HTA) methods guidelines for medical devices may benefit from contributions by biomedical and clinical engineers. Our study aims to: (i) review and identify gaps in the current HTA guidelines on medical devices, (ii) propose recommendations to optimize the impact of HTA for medical devices, and (iii) reach a consensus among biomedical engineers on […]
The Model recommends guiding principles, harmonized definitions and specifies the attributes of effective and efficient regulation, to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF).
Abstract Background Health Technology Assessment (HTA) has gained importance and is emphasized as instrument to guide health policy in rational decisions on resource allocation on health technologies. In 2015 the development of a National HTA strategy in Lithuania was undertaken. It is the intention of this paper to offer generic guidance for similar future initiatives. Methods […]
The purpose of these Guidelines for conducting Health Technology Assessment is to indicate the principles and acceptable methods of performing Health Technology Assessment to ensure high quality of analyses and reliable results. The target group of these Guidelines, in addition to AOTMiT employees, is the broadly understood HTA community, including employees of the Ministry of Health […]
A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC Introduction Pursuant to – section 6a of Annex I to Directive 93/42/EEC (amended by Directive 2007/47/EC) and to – section 5a of Annex 1 to Directive 90/385/EEC (amended by Directive 2007/47/EC), the demonstration of conformity with Essential Requirements for a medical device must include a clinical […]
The WHO technical specifications of Neonatal Resuscitation Devices was developed under the framework of the World Health Assembly Resolution WHA66.7, (5) which is at the foundation of the United Nations Commission on Life-Saving Commodities (UNCLSC) for Women and Children (Annex 10). The mandate of the UNCLSC is to promote and assure the availability of 13 safe, […]
These Guidelines for Preparing Assessment Reports for the Medical Services Advisory Committee (referred to in this document as the ‘Guidelines’) provide practical information on how to present evidence to MSAC when seeking Australian Government funding of a medical service. Although these Guidelines have been written for applicants from the medical profession and industry, they are also intended to provide information […]
This guideline on “Therapeutic medical devices”, with answered comments from the SAG / Public consultation, is the last guideline of WP7 Subgroup 3 in JA2.