New China FDA Document Clarifies Device Crackdown Plan
On 15 March 2014, the China Food and Drug Administration (CFDA) issued a question and answer document designed to clarify the purpose of an earlier 13 March 2014 notice on the new national Special Action Program (SAP).
That notice, sent to Chinese provinces and municipalities, called on local authorities to crack down on illegal activities relating to medical devices, and especially medical device registration, production, distribution and use.
The Program will run through 15 August 2014 and will focus on the prosecution of companies involved in illegal activities. It will also focused on ordering the marketing cessation of illegal devices, as well as mandatory recalls of defective devices nationwide.
A primary focus of the crackdown will be the registration of class II and III medical devices, especially clinical trial reports submitted by first time registration submissions for Class III devices.