CFDA announced Unique Device Identification (UDI) draft plan for feedback on August 22, to adequately identify medical devices through their distribution and use. When fully implemented, the label of all devices in China will include a unique device identifier in human- and machine-readable form. Feedbacks need to be submitted by September 21, 2018. This is the second round of UDI feedback requested by CFDA. The 1st round of UDI draft guideline was released on February 26, 2018.
According to the draft plan, the unique identifier should include the Device Identification (DI) and the Production Identification (PI). DI is the unique code identifying the license holder, the model and the packaging information of the medical device; PI is composed of codes related to the production process, the serial number, batch number, production date and expiration date.
CFDA has formulated relevant standards and specifications for UDI and established UDI database for public inquiry.
The license holder of the medical device shall upload the product identification and related data to the UDI database within 60 days after the product is approved or renewed, and before the commercialization of the product.
For English version of the draft guideline, please email info@ChinaMedDevice.com.
China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, RA, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 250+ companies’ success.