As of May 1, 2017, with the “Medical Device Recall Management Measures” Ordinance No. 29, some changes to Medical Devices recall process entered into force in China.
Changes concern the definition of defective Medical Devices while the recall process and the notification timing based on damage severity remain unchanged.
Medical Devices and IVDs manufacturers marketing in China are required to submit more information to the CFDA, as defined in the forms recently disclosed on the competent authority website.
It is important to bear in mind that the foreign manufacturer selling not only in China but also in other countries must now inform the Chinese Regulatory Authority of any recall activity in other markets.
For more information: