The Global Harmonization Task Force ( GHTF ) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry ” whose goal was the standardization of medical device regulation across the world. The representatives from its five founding members (the European Union , the United States , Canada , Japan and Australia ) were divided into three geographical areas: Europe , Asia-Pacific and North America , each of which actively regulates medical devices using their own unique regulatory framework. Founded in 1992, the GHTF was created in “an effort to respond to the growing need for international harmonization in the regulation of medical devices ."
26-557: The GHTF disbanded late in 2012. Its mission has been taken over by the International Medical Device Regulators Forum (IMDRF), a successor organization composed of officials from regulatory agencies— not industry — around the world. The GHTF website is no longer operational. As quoted from the GHTF site now (IMDRF), “The purpose of the GHTF is to encourage the convergence in regulatory practices related to ensuring
52-464: Is a government authority that is responsible for exercising autonomous dominion over some area of human activity in a licensing and regulating capacity. These are customarily set up to strengthen safety and standards, and/or to protect consumers in markets where there is a lack of effective competition . Examples of regulatory agencies that enforce standards include the Food and Drug Administration in
78-691: Is an example: The GMDN term and other associated data is copyright protected and the GMDN is a Trademark . Uniquely each GMDN term has a set of attributes, known as Collective Terms, which help to navigate the GMDN Database and aid the selection of a GMDN term by medical condition or product feature. The GMDN is used by regulators, healthcare providers and others for activities such as medical device recalls, adverse event reporting and postmarket surveillance and monitoring, as well as inventory control and other healthcare management functions. The GMDN Agency updates
104-610: Is appointed for a three-year term by the Steering Committee. Upon completion of the term, the Chair is re-evaluated by the Steering Committee based on the needs of the Study Group. The support of a Vice Chair member usually consists of a member from the industry in a different region from the Chair. Regulatory authority A regulatory agency ( regulatory body , regulator ) or independent agency ( independent regulatory agency )
130-648: Is available in English and other languages. The GMDN is part of the 'minimum data set' of the US FDA Unique Device Identification regulation for the registration of new Medical Devices intended for use in the United States. This follows the international consensus established by the International Medical Device Regulators Forum (IMDRF). The GMDN is required by the UK's national medical device regulator,
156-467: Is concerned with medical device vigilance such as medical device reporting and post market surveillance . The Group is designed to harmonize the data collection and reporting systems of the industry. Examples of documents put out by Study Group 2 include Medical Devices Post Market Surveillance: Content of Field Safety Notices , Manufacturer's Trend Reporting of Adverse Events and National Competent Authority Report Exchange Criteria including reference to
182-464: Is concerned with the current medical device regulatory systems. From examining the current field, the group isolates the principles suitable for harmonization as well as those that pose a threat to harmonization. The Group also deals with the standardization of pre-market submissions and product labeling. Examples of documents put out by Study Group 1 include Principles of Medical Devices Classification , and Labeling for Medical Devices . Study Group 2
208-421: Is consistent with the aims of both organisations to minimise duplication and to support harmonisation. The following objectives were agreed: The Agreement will benefit patients across the world and all users of SNOMED CT and the GMDN in promoting comprehensive terminology based medical records, covering the needs of regulators, the medical device industry and healthcare professionals. The arrangement will enhance
234-435: Is justified by the complexity of certain regulatory and directorial tasks, and the drawbacks of political interference. Some independent regulatory agencies perform investigations or audits , and other may fine the relevant parties and order certain measures. In a number of cases, in order for a company or organization to enter an industry, it must obtain a license to operate from the sector regulator. This license will set out
260-404: Is powered and driven by a sense of corporate social responsibility amongst the advertising industry." Regulatory agencies deal in the areas of administrative law , regulatory law , secondary legislation , and rulemaking (codifying and enforcing rules and regulations, and imposing supervision or oversight for the benefit of the public at large). The existence of independent regulatory agencies
286-710: The Global Harmonization Task Force (GHTF) that have since disbanded (2012) and replaced by the IMDRF GMDN is managed by the GMDN Agency, a non-profit organization and Registered Charity , which reports to its Board of Trustees, that represent medical device regulators and industry. The GMDN term is in the form of a 5-digit numeric GMDN Code cross-referenced to a specific Term Name and Definition, with which all specific medical devices having substantially similar generic features, can be identified. The following
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#1733086117871312-621: The Medicines and Healthcare products Regulatory Agency The government agency responsible for medical device safety in Australia Therapeutic Goods Administration require the GMDN when registering a product within its ARTG system The GMDN Agency has established long term cooperation with the IHTSDO . The Cooperation Agreement shall result in the use of the GMDN as the medical device component of SNOMED CT . This Agreement
338-678: The United States and the Medicines and Healthcare products Regulatory Agency in the United Kingdom ; and, in the case of economic regulation , the Office of Gas and Electricity Markets and the Telecom Regulatory Authority in India . Regulatory agencies may be a part of the executive branch of the government and have statutory authority to perform their functions with oversight from
364-689: The Founding Members' regions. Of the 8 members, up to 4 may be from the regulatory sectors and up to 4 from the industry sectors. The Chain and Vice Chair members of the controlling region are not to be included in this number. There are five study groups in the GHTF, each with a different focus. The size of each Study Group is to be determined by the Study Group Chair. Recommended members include one participant from each region with founding member status as well as appropriate numbers from regulatory agencies and industry technical experts. Study Group 1
390-420: The GMDN is to provide health authorities / regulators, health care providers, conformity assessment bodies and others with a single generic naming system. Medical device experts from around the world (manufacturers, healthcare authorities and regulators) compiled the GMDN, based on the international standard ISO 15225. The GMDN meets the need to identify medical devices at the global level, as identified in
416-483: The GMDN utilizing member change requests, to add a new generic device term or to change an existing Term Name or Definition. The decisions are made by an international expert team, according to ISO 15225. The GMDN Agency releases updates to the GMDN on a daily basis, on their interactive website, the GMDN Database. Only Members have access to the GMDN Database. Since 1 April 2019 GMDN membership and therefore access to GMDN Terms and Codes has been free of any charge. The GMDN
442-454: The Study Group Chair. The level of participation that an Observer is granted is also decided by the Study Group Chair. The purpose of the Steering Committee is to provide policy and direction for the GHTF. It is responsible for the assignment and oversight of new work items, adopt and monitor GHTF guidance documents and the authorization and promotion of GHTF training events. The Steering Committee members consist of up to 8 members from each of
468-413: The conditions by which the companies or organizations operating within the industry must abide. Regulatory regimes vary by country and industry. In the most light-touch forms of regulation, regulatory agencies are typically charged with overseeing a defined industry. Usually they will have two general tasks: In the event that the regulated company is not in compliance with its license obligations or
494-538: The experience of those with existing systems and/or pattern their practices upon those of GHTF Founding Members.” Stated succinctly, the organization aims to standardize medical device regulations around the world by exchange of information. The founding members consist of regulatory authorities or industry members from the EU, the United States, Japan, Australia and Canada because of their well established and high standards in medical device regulations. Members also participate in
520-516: The harmonization of the auditing process. Examples of documents put out by Study Group 4 include Training Requirements for Auditors and Guidelines for Regulatory Auditing of Quality Management . Study Group 5 is concerned with the convergence of clinical practices. This includes the harmonization of clinical terms, reports and evaluations. Study Group 5 has yet to produce any final documents, but areas of proposed topics include Clinical Evaluation and Clinical Evidence . The Study Group Chair member
546-697: The law, the regulatory agency may be empowered to: In some instances, it is deemed in the public interest (by the legislative branch of government) for regulatory agencies to be given powers in addition to the above. This more interventionist form of regulation is common in the provision of public utilities , which are subject to economic regulation . In this case, regulatory agencies have powers to: The functions of regulatory agencies in prolong "collaborative governance" provide for generally non-adversarial regulation. Ex post actions taken by regulatory agencies can be more adversarial and involve sanctions, influencing rulemaking , and creating quasi-common law. However,
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#1733086117871572-485: The legislative branch. Their actions are often open to legal review . However, some regulatory bodies are industry-led initiatives rather than statutory agencies, and are called 'voluntary organisations'. They may be not-for-profit organisations or limited companies. They derive their authority from members' commitments to abide by the standards applied by the regulator, for instance as the UK's Advertising Standards Authority says "The self-regulation system works because it
598-497: The roles of regulatory agencies as "regulatory monitors" provide a vital function in administering law and ensuring compliance. GMDN Global Medical Device Nomenclature ( GMDN ) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans. The main purpose of
624-600: The safety, effectiveness/performance and quality of medical devices, promoting technological innovation and facilitating international trade, and the primary way in which this is accomplished is via the publication and dissemination of harmonized guidance documents on basic regulatory practices. These documents, which are developed by four different GHTF Study Groups, can then be adopted/implemented by member national regulatory authorities. The GHTF also serves as an information exchange forum through which countries with medical device regulatory systems under development can benefit from
650-1020: The steering committee, which can recommend the inclusion of other participants in Study Groups to be a part of all GHTF activities. Participating members consist of representatives from regulatory agencies or medical device trade associations not a part of the founding members. Participating members are to facilitate the adoption of as much of the GHTF's policies in their region/agency as possible within legal parameters. Participating members can also take part in Study Groups as well as other expert working groups. Liaison bodies are public health organizations, international standard-setting bodies or other groups who can contribute to or benefit from participation in GHTF. Liaison Bodies are encouraged to promote GHTF guidelines to their members and incorporate them into their work. Liaison bodies are permitted to nominate observers for GHTF Study Groups and other expert working groups. Observers must be nominated by members and approved by
676-473: The use of the GMDN . Study Group 3 is concerned with examining and harmonizing current quality systems requirements. Examples of documents put out by Study Group 3 include Implementation of Risk Management Principles and Activities Within a Quality Management System and Quality Management Systems - Process Validation Guidance . Study Group 4 is concerned with examining current quality systems auditing practices and
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