Clinical Evaluation
Our clinical evaluation service includes clinical evaluation report (CER), overseas clinical data, real world data, and clinical trial service. It is very important to understand whether your current clinical data are accepted by NMPA before the launch of registration. China is such a unique country that the upfront clinical data assessment or a proper clinical strategy leveraging the innovative program play key role in the successful registration. It also saves your time and money and prevent you from the frustration during the registration.
Clinical Exemption
NMPA keeps update a Clinical Trial Exemption List (CTEL) based on the clinical practice and situation. If your product is included in the CTEL, you are good to go without clinical data. However, you must pay highly attention to make sure your product exactly matches the product code on the CTEL based on the product description and intended use. Sometimes consulting the NMPA is necessary to make sure its exemption qualification. GVMMedicalTM will help you to make the important decision
Clinical Evaluation Report (CER)
GVMMedicalTM will help you to determine your clinical evaluation pathway. Once CER is identified as the right pathway, we will work with you to define the predicates and do literature research and summarize the comparison results. Our RA experts are responsible for the preparation of the CER according to the regulatory requirement. A good CER is half of the success.
Overseas clinical data
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.
Real World Data
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. GVMMedicalTM 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.
Clinical Trial
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.
Clinical Evaluation owns 50%+ share of the submission data, that this is the most important part in the product registration. Work with us, you will save much time and money to leverage our expert team and advisors in net.
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.