Validity: NMPA certification is usually valid for 5 years. The validity period of the certification is calculated from the date of issuance.
Renewal requirements: During the validity period of the NMPA certification, manufacturers need to regularly renew their certification to ensure that their products continue to be compliant and meet relevant regulations. Here are some common aspects of update requirements:
Technical file updates: Manufacturers need to ensure that new product information, performance data, and test reports are included in their technical files. If there are changes to product specifications or design, these changes also need to be updated and reported to the NMPA.
Quality Management System Updates: Manufacturers need to maintain and update their quality management systems to ensure they are compliant with the requirements of the NMPA. This includes regular quality management system audits and improvements.
Clinical data updates: If a product involves clinical data, manufacturers need to regularly update these data to support the efficacy and safety of the product.
Market surveillance: Manufacturers need to actively participate in market surveillance, report any adverse events or recalls, and ensure that their products continue to meet the safety and performance requirements of the NMPA.
Notification of Changes: Manufacturers are required to notify NMPA of any material changes in product design or performance in a timely manner. These changes may require re-evaluation and renewal of certification.
Renewal Application: Manufacturers are required to submit an application for renewal of certification to the NMPA, providing updated documentation and information for review and re-evaluation of certification.