The National Medical Products Administration (NMPA) of China has released the “Guidelines for Onsite Inspection of Medical Device Operation Quality Management Standards,” which detail the process for on-site verification of business licenses for medical device operating enterprises, including any changes or extensions.
According to the guidelines, if an enterprise’s applicable projects fully meet the requirements or can be corrected immediately during the inspection, the outcome will be classified as “passed.” For a result of “rectification within a specified time limit,” the non-compliant items in key projects must not exceed 10%, and in general projects (excluding identified items), they must not exceed 20%. If the non-compliant items in key projects surpass 10% or in general projects exceed 20%, the inspection will be deemed “failed.”
In cases where the inspection result indicates a “deadline for rectification,” the enterprise is required to complete the necessary corrections within 30 working days following the completion of the on-site inspection. The enterprise must then submit a comprehensive rectification report to the department that conducted the original inspection.- Flcube.com
