2022 Sampling Inspection Plan for Medical Devices

2022 Sampling Inspection Plan was published (No.15-2022) by the NMPA (National Medical Products Administration) on February 22, 2022, for medical devices covering 60 products including electronic endoscope, hollow fiber dialyzer, sodium hyaluronate injection, etc.

Highlights - 2022 sampling inspection plan

• 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.