On February 22, 2022, the NMPA (National Medical Products Administration) published (No.15-2022) the 2022 Sampling Inspection Plan for medical devices covering 60 products including electronic endoscope, hollow fiber dialyzer, sodium hyaluronate injection, etc.
- The main focus of this year’s sampling inspection plan targets medical electrical equipment, in vitro diagnostic reagents, anti-epidemic medical supplies, etc.
- 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. However, there will be no arrangement available for re-inspection for oxygenerators, and 4 other products that require risk monitoring sampling inspections.
- 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 registrant, filer or legal agent should take immediate actions to carry out risk control measures once they receive a failure report from the sampling inspection
By Julie Zhang and Jacky Li. Contact Cisema if you would like to learn more.