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Resources

In order to quickly assist members on regulatory and export issues, the DTA has compiled a list of links to important resources.  Please note that DTA does not explicitly endorse any of the information and services offered by these sites.  They are listed strictly for members’ convenience.  For personal recommendations and assistance, please contact the DTA staff.

General Resources

510kFDA.com: Provides consulting on FDA 510(k) submissions.  Also has affiliated offices in Europe, China, and Brasil to assist with regulatory matters in those markets.

Emergo Group: Offers on-site consultation on international regulations and/or quality assurance.

Export.Gov: Brings together regulatory and export resources from various U.S. government agencies.  Medical device regulatory profiles can be found here.

Export-Import Bank: The official export credit agency for the United States, which helps to finance and insure the export of U.S. goods and services to international markets.

FDA Medical Device Advice: Provides a wealth of regulatory and export information for medical devices.  

Federation of International Trade Associations: Contains a vast amount of resources for companies seeking to engage in international trade.

Infobel: International telephone directory

The International Trade Administration: Offers many important services and information resources.  Their Gold Key Matching Service is especially useful for those looking for overseas business partners and seeking to understand the markets they are trying to enter.

PRSGroup: Provides political risk analysis for more than 100 countries.  

Suvison: Reference resource for world dental news, events, companies, and organizations.

U.S. Commercial Service Market Research Library: A searchable database of commercial guides, market reports, and market research.  

North America

TradePort: Repository of free information and resources for businesses that seek to conduct international trade to and from California.

DSA Consultants: Provides regulatory advice for regulatory requirements in Canada.

Europe

MDSS: A provider of Authorized Representative Services and a resource for regulatory information in Europe.

TED: Tender Electronic Daily is the online version of the “Supplement to the Official Journal of the European Union,” dedicated to European Public Procurement.  Members can search public procurement notices for new business opportunities.

Directorate General for the Trade of the European Commission: Provides news and resources for trade within the EU.

Thema: Provides regulatory consulting for medical devices in Europe.  Affiliated with 510kFDA.com.

China

TradeEasy: A search engine for products from Hong Kong and China.

Center for Medical Device Evaluation: Conducts the dossier review during the medical device registration process.  Translated summaries of the clinical evaluation procedure for Class II & III Medical Devices and technical guidance can be found here.

Certification Experts: Offer certification consulting for both China and internationally.  Affiliated with 510kFDA.com.

Other

Therapeutic Goods Administration: Provides regulatory information for medical devices imported and exported to Australia.