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
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
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.
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.
The Boulevard Providing valuable information about quality products and services available to individuals with disabilities and Healthcare professionals.