As innovation devices and first-of-kind products flood into China market, NMPA seeks to strengthen the clinical-trial approval requirements for certain devices. NMPA published the Catalog of Class III Medical Devices Requiring Clinical Trial Approval on December 23, listing these eight categories:
- Implantable cardiac pacemaker, implantable cardiac defibrillator with new design or new indication
- Implantable blood pump with new design or new indication
- Implantable drug infusion pump with new design or new indication
- Non-active implantable medical devices in orthopedic and dental applications which are not yet available on China or overseas market
- Absorbable long bone internal fixation products which are not yet available on China or overseas market
- Nano orthopedic implant which are not yet available on China or overseas market
- Combination device / bioactive factor / cell orthopedic implant which are not yet available on China or overseas market
- Newly-designed orthopedic or dental implants which are not yet available on China or overseas market
The implantable artificial organs, contact artificial organ and 3D printed devices are removed from the Catalog, showing the NMPA acceptance towards certain technologies.
Another positive side for manufacturers is that overseas clinical data is applicable for the eight categories of devices, according to the Guideline for Acceptance of Overseas Clinical Trial Data of Medical Devices issued on January 11, 2018.
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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.