Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Policies
Twenty-Three Medical Devices Proposed to be Exempted from Clinical Trial
NMPA published the “Clinical Evaluation Exempt Catalog for Medical Devices (Draft)”, which newly-includes 23 medical devices. Class III devices such as neuro-monitoring endotracheal tube, radioactive seed implantation puncture needle, high-pressure balloon dilation catheter with infusion port, atrial septal puncture sheath and drill for bone marrow infusion access are in the proposed catalog.
For the full list of devices, please click HERE
Additional Twenty-Five Hospitals Designated in GBA to Pilot Urgent Use Policy
On September 12, 2024, Guangdong Health Commission issued the third batch of applicable institutions to pilot urgent use policy, in which 25 hospitals are included.
Please click HERE for our comprehensive article on the GBA urgent use policy, the devices in the pool, the hospitals and the implementation procedure.
Clinical Trial Design Recommendations Issued for Six Types of Devices
The NMPA published the Clinical Trial Design Types Recommendations for Non-active Implantable Devices, Neurological and Cardiovascular Surgical Devices, Dental Instruments, Radiotherapy Devices, Diagnostic devices, and Examination and Monitoring Devices” on September 27, 2024.
These recommendations outline two potential clinical trial designs: “randomized controlled design” or “single-group design,” based on product names, structural composition, and intended use. For more information please click HERE
Fast-Track Approvals
Review Report Released for CryoLife’s Surgical Adhesive
The NMPA granted innovation approvals to CryoLife, Inc’s BioGlue Surgical Adhesive and issued a review report. The product is intended for open surgical repair of large blood vessels (such as the aorta, femoral artery, and carotid artery) in adult patients and can be used as an adjunct to standard hemostatic methods (such as sutures and needles).
The report has four sections: product overview, pre-clinical, clinical and risk-benefit analysis. For the outline of the report, please click HERE
About China Med Device, LLC
China Med Device, LLC (www.ChinaMedDevice.com) provides 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 you for product life cycle without your need to create a local entity in China. Our RA services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and PMS. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.