build your regulatory pathway in China with Atlas Operations
Regulatory Strategy Development
Partner Selection for Execution
Partner Selection for Execution
We collaborate with you to formulate a comprehensive regulatory strategy tailored to your medical device, considering its classification and intended use. This strategy outlines the necessary steps to achieve compliance with Chinese regulations, facilitating a clear pathway to market entry.
Partner Selection for Execution
Partner Selection for Execution
Partner Selection for Execution
Identifying and partnering with qualified local entities is crucial for efficient compliance processes. We assist in selecting reputable partners, such as authorized legal agents and local distributors, who are well-versed in China's regulatory landscape and can effectively support your compliance efforts.
Laboratory Testing Coordination
Laboratory Testing Coordination
Laboratory Testing Coordination
Compliance with Chinese standards often necessitates specific laboratory testing. We coordinate these tests, ensuring they are conducted in accredited facilities that meet the National Medical Products Administration (NMPA) requirements. This includes managing test protocols, timelines, and result evaluations to confirm your device's adherence to applicable standards.
NMPA Submission Management
Laboratory Testing Coordination
Laboratory Testing Coordination
The final step involves compiling and submitting a comprehensive registration dossier to the NMPA. We oversee this process meticulously, ensuring all required documentation, including test reports and clinical data, is accurate and complete. Our goal is to facilitate a smooth review process, leading to the successful approval of your medical device for the Chinese market.