Quality Assurance
& Legal Agent

QA Consulting

At our company, we provide comprehensive Quality Assurance (QA) consulting services for medical device manufacturers in China. Our team of experienced professionals works closely with clients to ensure that their products meet all regulatory requirements and quality standards, while also optimizing their business operations in China.

Quality Management System

NMPA Inspections

NMPA Change Filing & Registration

Post-Market Surveillance

Unique Device Identifier

QA Training

Other Services

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.

In-Country Representation (Legal Agent)

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.