Preliminary Announcement for San Francisco Medical Devices Regulatory Training Workshop (27-28 March 2014) on the Margins of the IMDRF Meeting


Medical Devices Regulatory Capacity Building Training Program for AHWP, ASEAN, Latin American and Other Medical Devices Regulators
March 27 - 28, 2014; San Francisco, California


Background:  The U.S. Department of Commerce and U.S. FDA invite global medical device regulators to participate in a two-day regulatory capacity building training program in collaboration with the World Health Organization (WHO) to take place on March 27-28 in San Francisco on the margins of the International Medical Devices Regulator Forum (IMDRF) March 25 meeting and the March 26 IMDRF stakeholders forum.  The draft agenda for this workshop (Attachment III) will be added to the next version of this announcement.  Space for workshop participation is limited so medical devices regulators are encouraged to register through the below e-mail address as soon as possible.  The workshop will be held in English and translation will not be provided and there will not be a registration fee to participate in this workshop.
Workshop Scope:  The workshop’s objectives are to share information of medical devices regulation based upon the Global Harmonization Task Force (GHTF) global model and in sharing information on the U.S. medical device regulatory system, including basic and advanced topics such U.S. registration and listing, device approvals/clearances, as well as Supply Chain Controls, Unique Device Identifiers (UDI), Software review practices and Combination Products.

Participants, Registration and Enquiry:  Anticipated workshop attendees are medical device regulators from APEC, ASEAN, Latin American and other economies. 

Mr. Gerry Zapiain, U.S. Department of Commerce,; 202 482 2410
Ms. Jane Earley, U.S. Department of Commerce,; 202 482 6241

The Registration form will be supplemented soon.