NMPA issued <The appendix to the Medical Device Operation Quality Management Standard: Guidance for On-site Inspection of Quality Management of Enterprises Providing Medical Device Transportation and Storage Service> and requested the medical products administrations to execute accordingly.
The guidance applies to on-site audits of enterprises providing medical device transportation and storage. During the on-site audit, the enterprises which comply with all requirements or are able to correct immediately can be considered as “Pass”. The enterprises that comply with all critical and 90% of general requirements are considered “To be corrected in time”. This means the enterprises shall correct the insufficiencies within 30 days and submit the correction report. Critical requirements are not met, or more than 10% of general requirements are failed, so the audit result is “Failed”.
For detailed requirements, please consult the attachment.
Attachment:
The Appendix to the Medical Device Operation Quality Management Standard: Guidance for On-site Audit of Quality Management of Enterprises Providing Medical Device Transportation and Storage Services
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