The NMPA (CFDA) News Roundup covers government announcements, policies, standards, guidelines, QA/recall/AE, and new approvals in medical devices and IVDs in China. It is edited by China Med Device, LLC (www.ChinaMedDevice.com), a consulting firm specializing in China NMPA (CFDA) regulatory affairs, CRO and market access services.
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Enables overseas manufacturers to find alternative clinical pathway
Pay attention to the timeline, device type and your code-issuing agency
28 draft registration guidelines were issued in one day
Leaders discussed the Real World Data (RWD) Pilot Program — a cost-effective and less time-consuming alternative to the traditional clinical trial — at a meeting in Boao, Hainan Province. NMPA hosted the meeting on October 10-11, joined by National and Hainan Provincial NMPA officials and eight overseas manufacturers.
Real World Data will become another clinical pathway for device approval in China. Overseas manufacturers can obtain approval for the RWD pilot program through Hainan provincial NMPA to start using devices in clinical settings prior to national NMPA approval. This is especially significant for manufacturers with high price tags, as RWD program participants can generate clinical data in the actual clinical environment with service fees whereas the traditional clinical trial needs to be complimentary. Certain protocols and guidelines need to be followed for the Real World Data to be admitted as part of the clinical evidence for submission.
Hainan is the first province to pilot Real World Data in China. It offers an additional clinical option to the currently available clinical pathways such as clinical evaluation report and overseas clinical data acceptance. As RWD can be used prior to national NMPA approval, it can significantly shorten the time to begin selling devices in China.
For our comments on Real World Data in Hainan, please click HERE.
NMPA’s final version of Unique Device Identification (UDI) Rules went into effect on 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.
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.
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.
The UDI Rules also implicates the requirements of submission materials. For the first trial group of 64 implantable 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.
For our comments on UDI Rules, please click HERE.
Class III device:
Class II devices:
Class II IVDs:
For our comments on the 28 guidelines, please click HERE.
2. NMPA published five final guidelines in October:
NMPA announced Recall Notices for 16 imported medical devices in October:
NMPA granted Innovation Status to two domestic manufacturers on October 28.
For slides on NMPA Regulatory Updates that we shared at RAPS Convergence 2019, please email info@ChinaMedDevice.com.
About China Med Device, LLC
China Med 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.