"Measures for the Administration of Medical Institution Recall" Article 4 (2 2) described "does not meet the compulsory standards、Products with registered or filed product technical requirements "，Refers to the mandatory standard for medical device that does not meet the factory of the factory or registered or filed medical equipment。Due to safety reasons，Standard Implementation Notice Except for special regulations。

For example: In 2010, the factory was released and sold and used a certain medical equipment that has so far.，In 2010, when the factory was released, it met the effective national standard at that time。and then，This mandatory national standard is updated，promulgated and implemented the new version of My stake betting appthe mandatory national standards in 2016。In this case，This product that has been listed and sold and used does not belong to the scope of recalled，But the product that the product released after the new version of the mandatory national standards in 2016 should meet the requirements of the new version of the mandatory national standard。