Registration Renew and Supplemental Submission
Using the overseas clinical trial data is a clinical evaluation pathway for registration in China when the requirements are satisfied. GVMMedicalTM RA team can help you to analysis your case and prepare the rationale and justification documents for you.
Technical Change
You are the king. Let us know your target and your concerns. Talk about your products.
Key Material/Supplier Change
China has so many innovative programs. Our US team will collaborate with China team to match your case to the best pathway for you.
IFU Change
We will communicate with you and review your documents to confirm its feasibility.
License Expires Soon
A comprehensive and organized report will be submitted to you in a timely manner.
GVMMedicalTM RA team can help you to analysis your case and prepare the rationale and justification documents for you.
QUESTIONS?
Whether you’re curious about a free talk, or even press, we’re here to answer any questions.
GVM MedTech RA/QA Service
Why Choose US
Good Knowledge
We dedicate to study the regulation update context that we provide you the accurate insight of the regulations.
Bilingual & Cross-Cultural Experts
Our project manager (PM), business development rep (BD), and part of the experts have background working in US and China.
A network of industry experts
The diversity of the medical device industry makes expert networks extremely important
Hard Working
We respect your time and money, our U.S. and Chinese teams worked together to create a 7/24 rhythm. We will try our best to keep your project proceed in a timely manner.