Friday, 01 April 2016｜Source：CHINA CHAMBER OF COMMERCEFOR IMPORT&EXPORT OF MEDICINES &HEALTH PRODUCTS｜Author：
FDA Workshop on Unique Device Identification Program was held jointly by FDA China Office and CCCMHPIE in Beijing on 22th March. Representatives from medical devices companies exporting to the United States and CFDA attended the workshop.
The workshop was presided by Cai Tianzhi, Deputy Secretary General of CCCMHPIE. Dr. Xu Ming, Vice President of CCCMHPIE and Ms. Leigh Verbois, Country Director of FDA China Office addressed the meeting.Nicole Taylor Smith，Assistant Country Director of FDA China Office and William M. Sutton, Deputy Director of Center for Devices and Radiological Health, elaborated on Class II medical devices exporting to the United States for registering of UDIs.
According to the request, on or before September 24, 2016, Class II medical devices exporting to U. S. must complete the registration on the UDI website. The involved preparation works include studying information on the UDI website, selecting an organization that operates a system for assigning of UDIs and bearing a UDI on the medical devices, selecting the primary means for submission, collecting data, knowing the framework of your GUDID account, identifying/obtaining your Dun & Bradsheet (D&B) Data Universal Number System (DUNS), obtaining a GUDID account, submitting the identifier number and subscribing to GUDID system messages to be timely informed of request status.
What Do You Need To Do Now?
Step 1 – Review resources on the UDI website.
Step 2 – Select an FDA-accredited organization that operates a system for assigning of UDIs according to the final rule. See “resources” links below for contact information.
Step 3 – Identify/Obtain your Dun & Bradsheet (D&B) Data Universal Number System (DUNS) number or if you don’t have a DUNS number, you must request one. D&B will take 30 – 45 days to assign you a number. There is NO FEE to request a DUNS number.
Step 4 – Request your GUDID account from the FDA. FDA expects to receive your request by April 2016 and no later than June 2016.
Step 5 – Submit the required information for your Class II medical devices to the GUDID.
Where Can I Find UDI Resources?
FDA’s UDI homepage at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/
CDRH Learn at: http://www.fda.gov/Training/CDRHLearn/
Who Do I Contact for Questions?
FDA UDI Help Desk at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ucm368904.htm
FDA’s Division of Industry and Consumer Education (DICE) at: DICE@fda.hhs.gov
FDA China Office at: ChinaFDA@state.gov
