QMS Establishment & Gap Analysis
QMS Audit & Rectification
Annual Self-Inspection Reporting
Overseas inspection
National sampling inspection
Unannounced inspection
Design change
Labeling change
Supplier change
Address change
Legal agent change
All other changes
Individual adverse event reporting
Periodic risk evaluation reporting
Recalls
UDI filing
UDI system maintenance
Manufacturer training
Distributor training
Supplier training
Advertisement review
Supplier and distributor audits
QMS Documents Translation
QA personnel recruitment
National and provincial procurement platform maintenance
We understand that navigating the regulatory landscape in China can be challenging, which is why we strive to provide our clients with practical and actionable solutions that address their unique needs and goals. With our QA consulting services, you can be confident that your medical devices meet all the necessary quality standards and regulatory requirements, while also achieving your business objectives in China.
Contact us to learn more about our QA consulting services and how we can help you ensure the quality and compliance of your medical devices in China.
If you are an overseas medical device manufacturer planning to sell products in China, you are required to have In-Country representation (legal agent) by law. At our company, we offer basic legal agent services that cover all the necessary aspects of the NMPA requirements. However, we understand that each of our clients may have unique needs and circumstances in China, which is why we also offer customized legal agent services to meet your specific requirements.
| Our basic legal agent services include: |
|---|
| Registering with the Chinese regulatory authorities on your behalf |
| Serving as your primary point of contact with the regulatory authorities |
| Providing translation and interpretation services |
| Coordinating with your authorized representatives in China |
| Keeping you informed of any regulatory changes that may affect your business operations in China |
We are committed to helping our clients navigate the complex legal requirements of doing business in China's healthcare industry. Contact us to learn more about our legal agent services and how we can help you meet your compliance obligations in China.