UDI Rules Take Effect on Oct 1, 2019: Pay Extra Attention if You are a Manufacturer of Implants

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UDI Rules Take Effect on Oct 1, 2019: Pay Extra Attention if You are a Manufacturer of Implants

NMPA published the final version of Unique Device Identification (UDI) Rules on August 27, 2019, with implementation date of October 1, 2019. The Rules are to adequately identify medical devices through their manufacturing, 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.

Database and Code-Issuing Agency

According to the Rules, 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.

NMPA has formulated relevant standards and specifications for UDI and established a UDI database. UDI code-issuing agencies are required to submit an Annual UDI Report for the previous year to NMPA, by January 31. The UDI code-issuing agencies have to be certified by NMPA.

Which UDI code-issuing agency do you use? We can confirm if the agency is certified in China.

The registrants shall upload, maintain and renew the product identification and related data on the UDI database after the product is approved or renewed, and before the commercialization of the product. And the registrants are held accountable for the authenticity, preciseness and completeness of UDI data.

Devices First Subject to UDI Rules

In mid-September, the First Group of Unique Device Identification Devices (Draft) specified 64 Class III high risk implanted devices going into first UDI trial. Click HERE for our comment for the list.

By August 2020, UDI Rules will be mandatory for the 64 medical devices, and the UDI requirement for other products will be implemented gradually.

The UDI Rules also implicates the submission materials. For the 64 devices, if the registration has been accepted or approved before August 1, 2020, the registrant shall submit the product identification, of the smallest sales unit, in the registration management system during the product’s renewal or modification.

We have translated For an English copy of the Unique Device Identification (UDI) Rules. Please email info@ChinaMedDevice.com. We charge nominal fees for the translation.

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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.