China medical device sampling inspection plan is announced annually by the National Medical Products Administration (NMPA) to inform registrants, filers and NMPA legal agents about the upcoming arrangements, in order to ensure that the post-market surveillance responsibilities are carried out as required.
The China medical device sampling inspection plan for 2023 was announced (No.28-2023) by the NMPA on March 31, 2023, with a total of 68 products covered including electronic endoscopes, medical oxygen concentrators (medical oxygen generators), intense pulsed light therapy devices, soft contact lenses, medical sodium hyaluronate gels, vascular stents, etc.
Inspection work requirements
Medical devices selected for sampling inspection this year are mainly medical electrical equipment, including medical imaging devices, physiotherapy devices, ophthalmic devices, etc. and even cover in vitro diagnostic reagents and passive implantable devices. The sampling inspection plan sets forward specific requirements for the basis and items for testing, as well as principles for decision making. The institutions for initial sampling inspection and re-inspection are also clarified in the announcement.
Re-inspection work requirements
- If there is any objection against the inspection results, only one chance will be given to appeal whilst the application for re-inspection should be submitted within 7 days after receiving the results.
- Re-inspection applications would be accepted and handled by the MPA of the respective province where the registrant, filer or legal agent belongs to.
- The announcement also published a list of agencies assigned by the China regulatory body for the arrangement of re-inspection.
- Upon receiving the results of the re-inspection, the re-inspection application can no longer be revoked.
- No re-inspection can be conducted for risk monitoring.
The notice also requires that the medical device registrant filer and the sampled unit shall take immediate risk control measures upon receipt of the product non-compliance report. Drug supervision and management departments should promptly organize the investigation and disposal, in line with the conditions of the case, timely investigation and punishment; suspected of crime, according to law, transferred to the judicial organs.
- Upon confirmation of products being listed for sampling inspection in 2023, registrants / filers should prepare in advance to ensure the product quality requirements have been met.
- Upon confirmation of products affected by the recent updates of the GB 9706 standards, registrants / filers should promptly prepare to comply with the requirements as stipulated accordingly. Read our recent article about the clarified implementation details of GB9706 standards for medical electrical equipment.
Read the full NMPA announcement on the medical device sampling inspection plan for 2023.
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