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Medical Device and Equipment Resource Center
Medical
Device Resource Center
This medical equipment resource center is designed for anyone who wants
information on the medical equipment marketplace. This page provides
many links on government regulations, organizations, references etc.
This medical device resource is for both buyers and sellers of medical
equipment. This page also has a special section on the Chinese Medical
Equipment Marketplace.
Feedback to rustamp@canada.com
Rustam Punja 604-806-0599, Vancouver, BC, Canada
Government
Reference Desk
Employment
China
and Medical Equipment
Organizations
Consultants
Buyers
Resource
Last update Jan 01,
2003
Government(regulations,laws,import,export...)
US
Food and Drug Administration
A MUST site for anyone involved
in the purchase, sale or manufacture of medical products. Site includes
a wealth of information: regulations, pre-market and post-market issues,
device alerts, international information and more
US
FDA Center for Devices and Radiological Health
An essential site for any person
or organization that sells, buys or manufactures medical equipment.
US
FDA Freedom of Information Services
Over 150,000 documents that record
the inner workings of the approval and regulation of medical devices,
pharmaceuticals, biologics, veterinary products, foods and cosmetics.
The
Food And Drug Law Institute
Provides a neutral
forum for critical examination of the laws, regulations, and policies
related to drugs, medical devices, other healthcare technologies, and
foods. Site also features a very informative daily email newsletter.
FedWorld.gov
A comprehensive guide to US governmental
databases.
bioinfoseek.com
Funded by the National Research
Council of Canada. Site contains biotech database with advanced searching
capabilities; information on bioregulations, bioresearch, bioassociations
and bioresearch in Canada, US, Australia, Asia, Europe, Africa and South
America;
The
Biotechnology Gateway
Developed and is maintained by
the Life Science Branch of Industry Canada. Portal site offering a rich
variety of information products and services on all aspects of biotechnology:
overview of the Canadian biotechnology industry, market reports, exporting
information, biotechnology regulatory virtual office, biotechnology employment
centre etc.)
Regulations
- Canada - Medical Devices
Food & Drug Act (Health Canada). Comprehensive list
of rules and requirements the government of Canada requires for the
sale and importation of medical devices in Canada.
European
Co-operation for Accreditation
The branches of European national
accreditation bodies have been handled separately by EAC (European Accreditation
of Certification) and EAL (European co-operation for Accreditation of
Laboratories) concerned with certification bodies or with laboratories.
These organisations have joined to form European Accreditation (EA) which
now covers all European conformity assessment activities: testing, inspection,
certification, environmental verification.
Global
Harmonization Task Force
Working towards harmonization
on medical device regulation.
US
FDA MedWatch
The FDA Medical Products Reporting
Program. Manufacturers, physicians, hospitals, consumers can report problems
with medical devices and drugs here.
US
Department of Commerce-International Trade Administration- Medical Devices
Provides assistance to U.S. medical
device exporters by working to open markets, disseminate information,
break down trade barriers affecting the industry, and conducting numerous
trade promotion events. Trade stats, foreign regulatory profiles, market
research, country policy info…
NRC
Information Centre Winnipeg
Branch library of CISTI, the Canada
Institute for Scientific and Technical Information. Medical device information,
intellectual property and more.
UK
Department of Health Medical Devices Agency (MDA)
Responsible for regulations concerning
medical devices. Provides guidance materials intended for manufacturers
and users of medical devices.
RSNALink
(Radiological Society of North America)
Primer on Medical Device Regulation.
A comprehensive three part series of articles reviewing medical device
regulation in the US.
US
FDA Regulation of Medical Devices: Background Information for International
Officials
How the FDA regulates
medical devices, what to do and how to comply.
Global
Import Regulations for Pre-Owned Medical Devices
The US Dept of Commerce offers
country-by-country information regarding regulations for import of used
medical equipment. Also provides info on which countries to expect sales
growth of preowned equipment. A MUST site if you plan to sell used equipment
abroad.
RegSource.com
Site aims to accelerate the development
of biotechnology and medical devices by radically improving access to
global regulatory and other product development information. The site
provides regulatory affairs information from agencies such as the US Food
and Drug Administration, European Medicines Evaluation Agency (EMEA),
Canada's Health Protection Branch (HPB), Medicines Control Agency (MCA)
and other international regulatory bodies. Excellent resource! You can
even download governmental forms here.
US
Center for Devices and Radiological Health International Program
The International Staff of the
Center for Devices and Radiological Health (CDRH) has developed this web
page to provide information about the Center's international programs
and activities. Also provide information which will facilitate the export
and import of medical devices.
American
Society For Testing and Materials (ASTM)
Developer and provider of voluntary
consensus standards, related technical information, and services having
internationally recognized quality and applicability that. Site also provides
lab directory and consultants directory
US
Customs Service
Provides information about importing
and exporting requirements, and about traveling to the United States from
other countries.
U.S.
International Trade Commission
This site provides information
and assistance regarding the export of products from the United States.
The site also offers trade statistics and import information. Through
this site, you can obtain information on both imports and exports of medical
devices, and other commodities.
U.S.
National Institute of Standards and Technology (NIST)
Provides information on a variety
of useful subjects including the National Voluntary Laboratory Accreditation
Program (NVLAP), which provides third-party accreditation of testing and
calibration laboratories
Australian
Therapeutic Goods Administration
Provides useful information about
the regulation of medical devices and pharmaceutical products in Australia.
Any product for which therapeutic claims are made must be entered in the
Australian Register of Therapeutic Goods (ARTG) before the product can
be supplied in Australia.
European
Agency for the Evaluation of Medicinal Products
Authorizing body
for the certification of medical products throughout EU countries. If
you want to sell to Europe you've got to come here.
German
Institute for Medical Documentation and Information
DIMDI has the task to set up database-supported
information systems for drugs according to the German Drug Law, and for
medical devices according to the Act on Medical Devices. Operates within
the Federal German Ministry of Health.
Health
Canada Therapeutic Products Programme (TPP)
Is the national authority,
which regulates drugs, medical devices and other therapeutic products
used in Canada.
CE
Marking
This is a Swedish government site
which provides specific information regarding CE marking, which is necessary
to market medical devices in the European Community member nations.
International
Laboratory Accreditation Cooperation (ILAC)
This site will be of interest
to anyone involved with: laboratory accreditation, quality assurance,
standardisation, testing, calibration, measurement, technical barriers
to trade, international acceptance of test data, international agreements.
Access ILAC publications, information on laboratory accreditation programs
around the globe, advice and assistance with technical issues related
to trade and acceptance of test results
California
Healthcare Institute
Advocate for California's biomedical
industry. Database of more than 2,500 biotechnology, pharmaceutical, medical
device, diagnostics and academic research organizations in California.
Free
The
Australian Society for Biomaterials
Provides a national focus for
professionals who have interests in research, education, development and
regulation of biomaterials and medical devices. Internationally, the Society
is a member of the group of Biomaterials Societies who coordinate international
activities, including the World Biomaterials Congress.
Japan
National Institute of Health Sciences
Provides useful information about
the regulation of medical devices and pharmaceutical products in Japan.
Reinventing
Regulation of Drugs and Medical Devices
FDA National Performance
Review - April 1995
Reference
Desk
Biotech
Database
This prototype Database for products
derived using Modern Biotechnology was developed to allow regulatory officials
in the OECD Member Countries to share information regarding certain products
or regulated articles that have been approved for commercialization or
are in the process of being approved for commercialization.
WWW
Virtual Library - Biotechnology Directory
This directory contains well over
1000 URLs of companies, research institutes, universities, sources of
information and other directories specific to biotechnology, pharmaceutical
development and related fields. It places emphasis on product development
and the delivery of products and services.
Medical
Device Safety Reports (MDSR)
MDSR is a repository of medical
device incident and hazard information independently investigated by ECRI,
a nonprofit health services research agency. Periodically updated review
(in case study format) of the types of problems that have occurred with
medical devices and lessons learned over the past three decades. It focuses
on the steps that medical device users and manufacturers can take to prevent
or reduce medical device risks to patient care and healthcare worker safety.
Search by: cause of incident, device type, clinical specialty/department.
An important site for professionals in the medical device industry.
Medical
Device and Diagnostic Industry Online Journal
Online and print journal covering
medical devices and regulations from MedicalDeviceLink.com
Institute
of Validation Technology
Educational resources, conferences
and other informational products for medical device compliance and validation
professionals on how to meet and beat strict US FDA standards.
Surgical
Innovation Resource Centre
Information resource for surgical
or medical doctors with ideas for new devices, instruments or inventions.
Protecting intellectual property, prototypes, financing, certification
in Europe and North America.
Medical
Design Technology
Covers new products, equipment,
instrumentation and materials for the medical device manufacturing market,
features a searchable product and supplier database
Device,
Drug, Equipment Medical Glossary
Glossary of over 3000 new terms
(drugs, devices, procedures, FDA approvals) updated weekly. A resource
for all health professionals. Site contains other useful resources (surgical
terms, classifieds, links etc).
Market
For Used & Refurbished Medical Products: Global Import/Export Regs
From Northern Lights
special collection. This link takes you to a short bibliographic summary.
The full text may be purchased for a fee.
All
Ethical Pharmaceuticals and Medical Devices in China
Market size in China for medical
equipment and devices is $5.5 bil; healthcare spending in China forecast
to reach $300 bil in 2001. From the Northern Lights special collection.
This link takes you to a short bibliographic summary. Full text may be
viewed for a fee.
MMC
Medical
The link between the newest technology
in medicine and international distribution. Intense growth in medical
technology requires partnerships between manufacturers and international
distributors to achieve a viable global presence.
European
Commission Multilingual Medical Glossary
Multilingual Glossary
of technical and popular medical terms in nine European Languages.
MedicalDeviceLink
Platform website for medical device
industry. Searchable database of over 4000 suppliers, 18,000 articles
pertaining to medical device industry and more. Current medical device
industry news.
India's
Medical Device Market Is Becoming Too Big to Ignore
Full text version. April 97. Free.
Significant economic reforms in the 1990s and a growing middle class have
greatly increased the purchasing power of the Indian health-care system
Employment
Weber
& Company
www.weberstaff.com
Executive search firm exclusively
serving the global needs of the Medical Device industry. Primarily recruits
in Regulatory Affairs, Quality Assurance, Manufacturing and Sales Management
for companies located in the United States, Europe, Latin America and
the Pacific Rim.
Future Bio Jobs
www.futurebiojobs.com
Lists jobs in Bioinformatics, Genomics, Proteomics, BioMEMs and Microfluidics. Also has listings of events and
links in these areas. Includes postings of academic Postdoc positions.
Harlan Staffing Consultants
www.harlanstaffing.com
Lists scientific, manufacturing, and executive searches in medical device, biotechnology and pharmaceutical industries.
BioView
Comprehensive biotechnology/pharmaceutical
employment site with thousands of job listings in all disciplines. The
site also contains a fully searchable resume database where candidates
can place their resumes for review by industry professionals.
Medical
Device Sales - Symbios Inc.
PRESENTLY THIS SITE APPEARS TO NOT FUNCTION!Maintains comprehensive jobs database
covering the Medical Device, Biotechnology, Pharmaceutical and medical
Instrumentation Sectors. Free.
China
and Medical Equipment (markets, regulations...)
Medisourceasia.com
Claims to be an authentic
Portal site on medical technology, equipment, devices, markets in Asia.
Asia
after the Crisis: Prospects for Foreign Medical Device Companies
Full text version.
Free. Printed in July 1999 issue of Medical Device and Diagnostics Industry
magazine.
China's
New Medical Markets
March/April 1998 - The International
Journal of Safety & Standards, Trends & Information. Provides general
info on structure and product approval process. Who makes decisions and
how they are made.
Medical
Devices in China Industry Sector Analysis
Focuses on the medical device
market in Southwest China, covering Sichuan, Yunnan, Guizhou, Tibet Autonomous
Region, and the Chongqing municipality. Excellent Source of info. Provides
contact names and numbers, market stats, import climate, domestic competition
(Chinese) and more.
Organizations
Health
Industry Distributors Association
Trade association representing
medical products distributors. Offer industry information & data, education
& training, governmental relations information and advocacy...
Association
of Medical Diagnostics Manufacturers
Indiana
Medical Device Manufacturers Council, Inc.
Association of medical
device manufacturers and other companies that have an interest in the
medical device industry in Indiana.
Medical
Device Network - Stanford University
The purpose of MDN is to encourage
and facilitate invention, patenting and early stage development of medical
devices.
Consultants
Wiley
& Company
Medical technology consulting
firm focusing on telemedicine technologies and applications of the Internet
in the health care sector. Areas of expertise include reimbursement planning,
FDA approvals, ISO compliance, and other market access issues.
FirstRanked Medical Device Marketingl
Interactive agency specializing in search engine based marketing techniques for the medical device and pharmaceutical industries.
Medical
Data International
Business knowledge company providing
the healthcare industry with information solutions, including conferences,
market and technology reports, newsletters, information databases, and
consulting.
Binnington Development Corporation
Industrial automation design, development, and consulting firm. Has a high speed data acquisition system product available that optimizes medical processing and manufacturing equipment
Technology
International, Inc.
Source for EU Regulatory
Compliance for CE Marking.
Emergo
Group, Inc
Provides a full range of product
compliance, quality assurance and export-related services for North American
and European manufacturers and exporters.
MedPanel
MedPanel provides market intelligence and communications for the pharmaceutical, biomedical / biotech and medical device industries. Online panels, advisory boards and surveys provide engagement with opinion leading physicians and other medical experts worldwide.
QNET
LLC
Quality assurance and international
trade consulting firm that specializes in CE Marking and ISO 9000/ EN
46000/ QS 9000.
IHS
Health Information
Offers compliance tools and news
services on Medicare and Medicaid reimbursement, hospital environmental
and safety issues, pharmaceutical and medical device approval and manufacturing.
Site includes a medical devices library.
The
Golden Triangle Organization Inc.
Provides international business
consulting services to medical device and biotechnology firms. Also publishes
international industry reports, including the 2001 China Medical Market
Report and the 2001 Indian Medical Market Report (fee for reports)
TUV
Rheinland
Offers manufacturers a quicker
and cost-effective way to have their products certified for both U.S.
and Canadian markets.
Buyers
Resource
The
Boulevard
Providing valuable information
about quality products and services available to individuals with disabilities
and Healthcare professionals.
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