NMPA (CFDA) issued “Medical Device Animal Study Technical Review Guideline Part I: Decision Principles” on April 19. The guideline lists 12 devices as examples to discuss if animal study is needed:
- Porous coated bioprosthetic hip prosthesis
- Electrocardiography machine
- Cross-linked sodium hyaluronate gel for injection
- Absorbable hernia patch
- External defibrillation products
- Ultrasound soft tissue cutting hemostasis system
- Implantable pacemaker
- Drug eluting stent
- Degradable metal screws for internal fixation
- Absorbable surgical anti-adhesion products
ChinaMed Device, LLC can help you produce NMPA compliant clinical trial protocol and conduct the whole clinical process. Our latest clinical success case, for CT-Accelerator, can be found HERE.
For English version of Animal Study Guideline Part I: Decision Principles, please contact info@ChinaMedDevice.com.
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About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent overseas manufacturers for the complete product life cycle without their need to set up local entity in China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification.