Global Glossary
GLOBAL GLOSSARY
Brazil
ABIMO – domestic medical device association
ANVISA – regulatory agency that approves product registrations and re-registrations and now requires economic data as a condition for sales.
GOB - Government of Brazil
China
AmCham - The American Chamber of Commerce in China - Industry association representing U.S. companies and individuals doing business in China, with more than 2,100 individuals from more than 900 companies. AmCham’s mission is to provide a forum for Americans engaged in business in China and to work with Chinese and U.S. government authorities to help foster constructive commercial relations between the two countries.
AQSIQ – General Administration of Quality Supervision, Inspection and Quarantine - One of the two main Chinese government agencies that tests medical devices prior to regulatory approval and conducts audits of manufacturing facilities. While it claims to test for electrical safety, in reality the tests and audits it conducts are virtually identical to those conducted by the State Food and Drug Administration (SFDA).
CAMDI – China Association for Medical Device Industry - China’s largest domestic medical device industry association, which has a formal relationship with several government agencies, including SFDA and the NDRC. More than 4, 000 companies are members of CAMDI.
MOFCOM – Ministry of Commerce - Chinese government ministry charged with regulating both domestic and foreign trade, attracting foreign investment, and helping Chinese companies abroad. MOFCOM is also charged with implementing trade policy, such as the WTO commitments, and competition policy, such as anti counterfeiting efforts.
MOH – Ministry of Health - Chinese government ministry charged with overseeing the hospital system; researching and drafting healthcare laws, development plans, and technical and hygienic standards; and developing educational programs. The Minister of Health is co-chair (with the Chairman of the NDRC) of the Chinese government’s healthcare reform task force.
NDRC – National Development and Reform Commission - Chinese government agency responsible for directing policies related to China's industries, price reform, fixed-asset investment, and western development.
PRC – People’s Republic of China - The formal legal name of the country of China.
SFDA – State Food and Drug Administration - Chinese government agency charged with the registration, testing, and administration of pharmaceuticals, over-the-counter drugs, traditional Chinese medicines, and medical devices. In addition, SFDA determines guidelines for the use of medical devices in China. SFDA is still recovering from a corruption scandal; in June 2007, their former Administrator was executed after being convicted on corruption charges.
Europe Union
COCIR – Association of the European Radiological, Electro medical and Healthcare IT Industry
EDMA – European Diagnostic Manufacturers Association
EUCOMED – European medical device association
MDD – Medical Device Directive (93/42/EEC)
France
APIDIM – Association of US-Based device manufacturers in France.
APPAMED – Syndicat de l’Industrie des Dispositifs de Soins Médicaux, Association of Medical Disposables and Therapies
GHS – Groupes Homegenes de Sejour, French DRG-style hospital payment system.
HAS – French High Authority on Health
SNITEM – Syndicat National de l'Industrie des Technologies Médicales, French Medical Devices and Equipment Association
Germany
Aktion Meditech – joint public relations campaign by BVMed, AdvaMed and interested member companies
BVMed – German medical technology association
GOG – Government of Germany
IQWiG - Institute for Quality and Efficiency in Healthcare (IQWiG) - is responsible for organizing the HTA of new products and procedures, based on a scientific methodology and makes recommendations to the JFC.
JFC - Joint Federal Committee (Bundesausschuss Krankenhaus also called G-BA) - The G-BA performs the political and economical appraisals and its conclusions are used to create binding coverage policies that define the catalogue of the mandatory statutory health insurance benefit-package.
SHI – Statutory Health Insurance
India
DCG(I) – Drug Controller Government (India) – regulatory agency that approves product registrations under “guidelines;” expected to be replaced by Central Drug Authority in the future.
GOI- Government of India
Italy
Assobiomedica – Italian association for medical devices – as of September 14, this is part of Federazione Assobiomedica and the medical device portion is “Assobiomedicali”. The IVD portion is “Assodiagnostici”.
CUD – technical body of the MOH with the function to analyze the minimum and maximum unit prices for medical devices and assign the reference price for each product to be sold to the NHS.
GOI – Government of Italy
MEF – Ministry of Economy and Finance
MOH – Ministry of Health
NHS – National Health System
Japan
MHLW – Ministry of Health, Labor, and Welfare
HIB – Health Insurance Bureau, the unit within MHLW that determines reimbursement rates.
PMDA – The Pharmaceuticals and Medical Devices Agency, which reviews product submissions and has post-market responsibilities.
DSA – Dynamic Strategies Asia, a consultant AdvaMed has retained to help with public advocacy in Japan.
LEK – An international consultant AdvaMed utilizes for reimbursement and other projects; offices in Tokyo and elsewhere
FAP – Foreign Average Pricing, Japan’s system for using prices in 4 overseas countries to help set prices in Japan.
Chuikyo – Japan’s Central Social Medical Insurance Agency, an advisory body to MHLW on reimbursement policy and prices.
ACCJ – American Chamber of Commerce in Japan
LDP – Liberal Democratic Party, Japan’s ruling political party.
Diet – Japan’s parliament
GOJ – Government of Japan
Korea
KFDA – Korea Food and Drug Administration
MOHW – Ministry of Health and Welfare
ROK - Republic of Korea
United Kingdom
ABHI – Association of British Healthcare Industries - AdvaMed’s primary local partner in the UK
BHTA – A British association representing durable medical equipment suppliers, ostomy and incontinence companies.
CD – Commercial Directorate - The unit within the English Department of Health that manages national procurement policy.
DoH – English Department of Health, which also is the lead organization within the NHS for many NHS-wide programs, like the HRGs
BIVDA – British In-Vitro Diagnostics Association - AdvaMed’s partner for IVD related issues.
HRG – Healthcare Resource Group - The British equivalent to Diagnosis Related Groups for hospital payment. Currently used in England and Wales.
MTG – Medical Technology Group - AdvaMed’s joint lobbying campaign with ABHI focused on a range of issues affecting patient access to medical technologies.
NHS – National Health Service
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