Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros issued in April 2022. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Policies
These Devices Do Not Need Clinical Trial: Faster Market Access for Cardiac Rhythm Management, Orthopedic and Neurosurgery Companies
The NMPA issued the “Clinical Pathway Recommendations for Certain Active Devices and Non-Active Devices” on April 6, 2022. The document suggests manufacturers how to choose predicate-device-comparison or clinical trial for clinical evaluation. 22 active devices and 55 non-active devices are affected.
NMPA agrees that certain cardiac rhythm management, orthopedic and neurosurgical devices can choose predicate device comparison pathway, instead of lengthy and costly clinical trial. See the full list of devices.
23 Mandatory Standards to be Issued in 2022: Ophthalmic, Orthopedic, Cardiovascular and More
NMPA finalized the “2022 Medical Device Industry Standards Revisions Plan” on April 28, 2022, just two weeks after the draft version. The plan includes 23 mandatory and 93 recommended standards. The Standards Revisions are aimed to facilitate manufacturers with local type testing and regulatory submission and make standards more consistent with the international standards.
Check out the complete list of the mandatory standards to be established or revised.
Interpretation on China GCP: Renewed Requirements on Multi-Regional Trials and Safety Reporting
NMPA issued the interpretation of the “Quality Management Practice Specification for Clinical Trials of Medical Devices” which will be implemented from May 1, 2022.
The “China GCP” covers the whole process of medical device clinical trials, including the design, implementation, supervision, inspection, inspection, data collection, recording, preservation, analysis, summary, and reporting. Look at our comprehensive review with the changes NMPA emphasized by NMPA.
All Class III Devices, IVDs Subject to UDI Starting June 1, 2022
Unique Device Identification (UDI) will be implemented with all Class III devices and IVDs, effective from June 1, 2022. It was announced by NMPA at the “Notice on Applying Unique Device Identification System for the Second Group of Devices” published in September 2021.
69 high-risk class III devices were included in the UDI application of First Group of Devices, which started from January 1, 2021. Now all the rest of Class III devices will follow suit. Also, it is the first time the UDI requirements apply to IVDs. Read our comprehensive review.
Fast-Track Approvals
Radiology, Orthopedic Equipment Gain Innovation Approvals in April
The NMPA granted Innovation Approvals to two equipment in April 2022:
- Radiology: Magnetic resonance imaging system
- Orthopedic: Hip replacement surgery navigation and positioning system
NMPA also issued the list of 151 innovation approvals since the pathway established in 2014.
Read more about know why the NMPA nodded on these innovative devices.
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 legal agent with offices in Boston, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our regulatory services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.