NMPA (CFDA) issued the First Group of Unique Device Identification Devices (Draft) for feedback on September 17, and specified the medical devices going into UDI implementation.
In early July, NMPA UDI Implementation Plan stated that “high risk implanted devices, such as cardiac implants, brain implants and prosthesis, are included in the first trial”. At this time, the First Group elaborated the Plan, and listed 64 Class III medical devices including:
- Cryoablation needle and catheter
- Absorbable suture
- Guiding catheter
- Balloon dilatation catheter
- Cutting balloon
- Thrombus aspiration catheter
- Cardiac occluder delivery cable
- Intravascular recovery device
- Capsule endoscope system
- ADSL filters
- Implantable pacemaker
- Implantable hearing device
- Knee prosthesis
- Hard brain (ridge) membrane patch
- Endovascular prosthesis
- Vascular Stent
- Plastic filling material
- Implantable access ports and accessories
- Intraocular Lens
At the same time, the document specifies the timelines for implementing UDI system for the first group of devices:
- From October 1, 2020, the medical devices produced shall have unique identifiers;
- Starting October 1, 2020, for initial registrations, the applicants shall submit the identifiers of smallest sales unit to the registration management system;
- Before October 1, 2020, for renewal and modification registrations, the applicants shall submit the identifiers of smallest sales unit to the registration management system;
- From October 1, 2020, before sales, the registrant shall upload the product identifiers and related data of the minimum sales unit and the higher-level package to the unique identification database.
For English version of UDI rules NMPA published on August 27, 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.