Product Registration
Product registration is the key to enter into China market. It is a scientifical and artistical process. Extensive industry knowledge, deep regulatory experience, and understanding of the relative CDME reviewers’ styles have great impact on the registration process and result. Good project management practice and good communication skills with both clients and NMPA also play an important role throughout the registration process.
We provide you the professional service by taking care of each of the above aspects, no matter it is the initial registration, the product license renewal, the supplemental submission, or the modification submission.
Registration Strategy
Product registration is the key to enter into China market. A good registration strategy is essential to your successful registration.
See what we will do.
Listen to You
You are the king. Let us know your target and your concerns. Talk about your products.
Match the Best Pathway
China has so many innovative programs. Our US team will collaborate with China team to match your case to the best pathway for you.
Feasibility analysis
We will communicate with you and review your documents to confirm its feasibility.
Report to You
A comprehensive and organized report will be submitted to you in a timely manner.
Product Registration
Product registration is scientifical and artistical process. Extensive industry knowledge, deep regulatory experience, and understanding of the relative CDME reviewers’ styles have great impact on the registration process and result. Good project management practice and good communication skills with both clients and NMPA also play an important role throughout the registration process. We provide you the professional service by taking care of each of the above aspects, no matter it is the initial registration, the product license renewal, the supplemental submission, or the modification submission.
Listen to You
You are the king. Let us know your products.
Identify the GB/YY standards
China has so many innovative programs. Our US team will collaborate with China team to match your case to the best pathway for you.
Product Technical Requirement (PTR)
We will communicate with you and review your documents to confirm its feasibility.
Type Testing
A comprehensive and organized report will be submitted to you in a timely manner.
Preclinical Safety Testing
You are the king. Let us know your products.
CER or Clinical Trial
China has so many innovative programs. Our US team will collaborate with China team to match your case to the best pathway for you.
Dossier Preparation and Submission
We will communicate with you and review your documents to confirm its feasibility.
Approval
A comprehensive and organized report will be submitted to you in a timely manner.
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.
Accelerated Registration Pathway
Real world data program was adopted by Hainan Boao Medical Pilot Zone. Medical devices marketed overseas but not yet access to China market can be licensed for import to the Hainan Boao Medical Pilot Zone. Patients may apply and use them through Real-World Data program. Our RA team can help you to analysis and determine whether your products qualified by this policy. By leverage this policy, your registration process will be shortened significantly. The cost is much lower as well.
Innovative Product
You are the king. Let us know your target and your concerns. Talk about your products.
Emergency Use
China has so many innovative programs. Our US team will collaborate with China team to match your case to the best pathway for you.
Humanarity Use
We will communicate with you and review your documents to confirm its feasibility.
Real-World Data
A comprehensive and organized report will be submitted to you in a timely manner.
Overseas Clinical Data
A comprehensive and organized report will be submitted to you in a timely manner.
Made-in-China Strategy
While clinical trial is your only pathway of clinical evaluation, GVMMedicalTM RA team and CRO team will work together to help you to identify the minimum regulatory requirement. Besides preparation the Clinical trial protocols for you, our CRO team is also very experienced to manage your clinical trial process and prepare the clinical trial report.
Order 104 Pathway
You are the king. Let us know your target and your concerns. Talk about your products.
MAH pathway
China has so many innovative programs. Our US team will collaborate with China team to match your case to the best pathway 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.