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Nonclinical Safety Evaluation of Medical Devices
Published in Pritam S. Sahota, James A. Popp, Jerry F. Hardisty, Chirukandath Gopinath, Page R. Bouchard, Toxicologic Pathology, 2018
Kathleen A. Funk, Victoria A. Hampshire, JoAnn C. L. Schuh
Formerly called the Global Harmonization Task Force (GHTF), the IMDRF is a global working group of medical device regulators addressing harmonization and providing guidance on medical device quality and safety requirements.
Vietnam: Medical Device Regulatory System
Published in Jack Wong, Raymond K. Y. Tong, Handbook of Medical Device Regulatory Affairs in Asia, 2018
Medical Device Decree No 36/2016/ND-CP, which was issued on 15 May 2016, regulates the management of medical devices including classification of medical devices, production, circulation, sales, purchase, providing services, information dissemination, labeling; and management, use of medical devices in medical facilities. The new regulatory system is largely based on the ASEAN Medical Device Directives (AMDD), which refer to the Asian Harmonization Working Party (AHWP) and the Global Harmonization Task Force (GHTF) directives. The GHTF is a voluntary consortium with representatives from the trade and regulatory authorities from the United States, Canada, Australia, Japan and the European Union formed in 1992 to harmonize the standards and principles of regulating medical devices.
Drug Monitoring: Modern Approaches to Quality Assurance
Published in Steven H. Y. Wong, Iraving Sunshine, Handbook of Analytical Therapeutic Drug Monitoring and Toxicology, 2017
The Global Harmonization Task Force has membership from Europe, Canada, the U.S., Japan, industry, and government. The objective of this task force is to facilitate the move toward harmonization of international standards and to facilitate worldwide marketing of new products through less duplicative testing to meet the standards of different countries. The Harmonization Task Force and the International Standards Organization (ISO) formed Technical Committee 210, which is working on the application of quality system standards for medical devices. The Japanese Ministry of Health (MHW) has issued a new Medical Device Good Manufacturing Practice (GMP) proposal, which is very close to ISO 9001 plus European Standard (EN) 46001. This contributes to potential harmonization of medical device GMPs. Other countries are expected to proceed in the same general direction. These activities will lead to the U.S. and other countries’ “harmonizing” and mutually recognizing quality system standards (e.g., the European Unions “EN 46001” standard and the FDA’s proposed new GMPs). The future work of ISO/TC 210 with respect to quality systems will focus on the refinement of the basic documents and related guidances. In the course of its deliberations, TC 210 is expected to take into account the practices of other countries, including the U.S. FDA’s GMP regulations.
Regulatory requirements and optimization of multiple criteria decision analysis to quantify the benefit-risk assessment of medical devices
Published in Expert Review of Medical Devices, 2023
GHTF was a voluntary group of representatives from the national medical device regulatory authorities and regulated industry. The purpose of the GHTF was to ‘encourage convergence in regulatory practices related to ensuring the safety, effectiveness/performance, and quality of medical devices, promoting technological innovation and facilitating international trade, and the primary way in which this was accomplished was via the publication and dissemination of harmonized guidance documents on basic regulatory practices’ (https://www.imdrf.org/ghtf/mission-summary). In 2007, the GHTF published a guidance document ‘Clinical Evaluation (SG5/N2R8:2007),’ in which the requirement for BRA was clearly described as ‘a manufacturer should periodically review the performance, safety, and benefit-risk assessment of the device through a clinical evaluation and update the clinical evidence accordingly [11].’
Evolution of China regulatory guidance on the clinical evaluation of medical devices and its implication on pre-market and post-approval clinical evaluation strategies
Published in Expert Review of Medical Devices, 2023
Regulatory guidance on medical device clinical evaluation has become increasingly harmonized worldwide over the last 20 years. This is because guidance at the country or regional level is often transformed from the guidance documents of the International Medical Device Regulators Forum (IMDRF) [3]. The IMDRF is a voluntary group of medical device regulators from Australia, Brazil, Canada, China, the European Union, Japan, Russia, Singapore, South Korea, the United Kingdom, and the United States of America that come together to develop strategies for harmonizing international medical device regulations. IMDRF continued the work of the Global Harmonization Task Force (GHTF; replaced by IMDRF in 2012). While the organization’s name was changed, its goal remains to accelerate harmonizing international regulations for medical devices to ensure safety, effectiveness or performance, and quality of medical devices, promote technological innovation, and facilitate international trade. To achieve this goal, the IMDRF publishes and disseminates harmonized guidance documents on regulatory practices, such as guidance on clinical evaluations.
Regulatory convergence of medical devices: a case study using ISO and IEC standards
Published in Expert Review of Medical Devices, 2018
Kuniki Imagawa, Yoshiaki Mizukami, Seiko Miyazaki
The regulation of medical devices around the world varies greatly, with regulations ranging from comprehensive to nonexistent. To provide safe and effective medical devices to patients in a timely manner, it is important to achieve regulatory convergence. The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory convergence. It is a voluntary group of medical device regulators from various jurisdictions around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and to accelerate international medical device regulatory convergence. The current members are Australia, Brazil, Canada, China, the Russian Federation, the European Union (EU), the USA, Singapore, South Korea, and Japan [1]. The IMDRF conducted a survey regarding the number of standards, such as those from the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) [2]. Also, statements regarding how to use the basic standards, which are applicable to a wide range of products and/or processes, have been published in each jurisdiction [3–7]. The survey and statements found that each IMDRF jurisdiction uses many ISO and IEC standards in its regulations. For example, the EU uses the European National (EN) standard, based on ISO and IEC standards, as the harmonized standard in the official journal of the EU. The US also uses ISO and IEC standards directly in regulations that are published as recognized consensus standards in the Federal Register of the US government. In Japan, the Japanese Industrial Standard (JIS), which is derived from ISO and IEC standards, is used in regulations especially for third-party certification. Considering this background, the aim of this review was to describe the current situation regarding regulatory convergence using ISO and IEC standards in the regulations of the EU, the USA, and Japan on the basis of third-party certification in Japan.