Medical Device Regulatory Consulting Service
The CIRS Medical Device Team specializes in providing regulatory compliance, market intelligence, quality assurance, IPR protection and clinical consulting services to global medical device and IVD manufacturers or suppliers seeking to market their product into China.
We take care of every aspect of the medical device project. CIRS offers turnkey consulting services across the product’s life cycle in Chinese market from helping foreign company with pr-market investigation, regulatory strategy, test, clinical study, quality assurance, risk management, registration and market-access approval in China to assisting registered companies with post-market monitoring and update, Customs clearance and intellectual property right (Trademark, Patent and copyright) protection, adverse event monitoring.
Our dedicated consulting team provides consulting and regulatory support based on the full understanding of the CFDA regulations and the practical experience on medical device regulatory compliance in China.
The following is a list of our services. Please contact us if you have any questions regarding your project.
- Pre-market Investigation & Analysis
- Medical Devices Registration & Approval
- Clinical Trial Consulting
- Manufacturing and Distributing License Approval
- Quality Assurance & Compliance
- Risk Assessment & Management
- Customs Clearance
- IPR Protection in China
Please join in our “China Medical Device Regulatory Assistant Program” for free proposal. For complex and urgent projects, we will assign a dedicated project manager to customize a program specific to your requirements. We are ready to be of service at any time.