NMPA (CFDA) and National Health Commission announced the “Unique Device Identification (UDI) System Implementation Plan” on July 7. The UDI system has been established to “adequately identify medical devices through their manufacturing, distribution and use in China”. The label of all devices in China will include “a unique device identifier in human- and machine-readable form, benefiting traceability in product registration, clinical, adverse event reporting, recall and medical insurance.”
High risk implanted devices, such as cardiac implants, brain implants and prosthesis, are included in the first trial, according to the UDI Plan. Participants include overseas and domestic Marketing Authorization Holders (MAHs), manufacturers, distributors, user facilities, research institutes, device labeler, etc.
The Plan also specifies the timeline:
- July 2019, identify piloting device categories and participating units. Establish a working group, issue a work plan and organize training. The pilot units shall clarify the acceptance indicators;
- From August to November 2019, application of unique identifiers is to be verified;
- By February 2020, the uploading, downloading and interface standards are to be verified;
- From March to June 2020, inter-departmental convergence and extension applications will be organized by NMPA;
- In July 2020, NMPA will organize a summary meeting and issue a summary report for the pilot implementation of the UDI on the first batch devices.
NMPA released two draft versions of “Unique Device Identification (UDI) System Implementation Rules” on February 2018 and August 2018 respectively. The final guideline will be published by the end of this year, according to “Key Tasks of the Medical Care Reform in 2019” issued by the China State Council.
Based on the latest 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.
When fully implemented, 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 Unique Device Identification (UDI) System Implementation Rules (Draft), please email info@ChinaMedDevice.com.
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About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.