The review cycle and implementation rules for NMPA (National Medical Products Administration) certification applications in China involve several key phases and considerations:
Application Submission: The process begins with the submission of a comprehensive application dossier to NMPA. This dossier includes all required technical documentation, test reports, clinical data (if applicable), and information on the quality management system (QMS).
Initial Review: Upon receiving the application, NMPA conducts an initial review to check for completeness and adherence to regulatory requirements. If any deficiencies are found, the applicant may be requested to provide additional information or clarification.
Technical Review: For Class II and Class III devices, NMPA conducts a thorough technical review. This involves evaluating the technical documentation, test reports, and QMS documentation to ensure compliance with Chinese regulatory standards and safety requirements.
Testing: Devices typically undergo testing according to applicable Chinese national standards or recognized international standards. Testing is performed by NMPA-accredited laboratories to verify device safety, performance, and quality.
Clinical Evaluation (if applicable): Class II and Class III devices may require clinical evaluation to demonstrate safety and efficacy. This may involve providing clinical data or conducting clinical trials in accordance with NMPA guidelines.
Expert Panel Review (for Class III devices): High-risk Class III devices undergo a review by an expert panel assembled by NMPA. The panel evaluates the clinical data, technical documentation, and risk management measures associated with the device.
Decision and Certificate Issuance: After completing the review process, NMPA makes a decision regarding the certification application. If approved, a NMPA registration certificate is issued, indicating compliance with Chinese regulatory requirements and allowing the device to be marketed and used in China.
Renewal and Amendments: Certificates issued by NMPA are typically valid for a certain period (often 5 years) and may require renewal. Any changes to the device design, manufacturing process, labeling, or intended use during the certification period must be reported to NMPA and may require additional approval.
Post-Market Surveillance: Once certified, manufacturers are required to establish and maintain post-market surveillance systems. This involves monitoring the performance of the device in real-world settings, collecting feedback from users, and reporting adverse events to NMPA as per regulatory requirements.
Local Representation: Non-Chinese manufacturers must appoint a local authorized representative in China who is responsible for regulatory compliance and communication with NMPA throughout the certification process and during post-market surveillance.
Navigating the NMPA certification process requires careful preparation, adherence to regulatory requirements, and often involves collaboration with local experts familiar with Chinese medical device regulations. Timely and accurate submission of all required documentation and responsive communication with NMPA are crucial for successful certification and market entry in China.
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