Regulatory Focus™ > News Articles > China Announces Major Overhaul of Device Regulation

China Announces Major Overhaul of Device Regulation

Posted 02 April 2014 | By Louise Zornoza 

On 31 March 2014, the China Food and Drug Administration (CFDA) and China's State Council Legislative Affairs Office announced the first major overhaul of the regulations governing medical devices since the system's inception in April 2000. 

The end product of six years of effort, the amended Regulations on the Supervision and Administration of Medical Devices are scheduled to go into effect on 1 June 2014, with additional implementing rules to be released over the next few months. 

The new regulations establish three classes of device based on the degree of risk posed, from low to high. Products in the low risk class (Class 1) will only need to file documentation with the relevant municipal FDA, whereas moderate (Class 2) and high (Class 3) risk devices will be subject to premarket review and approval by CFDA. 

The new regulatory scheme tightens regulatory control of the industry, with more stringent good manufacturing practice (GMP) and good supply practice (GSP) compliance and strengthened post-market supervision requirements. Fines for illegal manufacturing or selling of medical equipment will be up to 20 times the value of the goods, as compared to the cap of 5 times the value in the original rule. In the most serious cases, companies can be barred from applying or renewing the relevant licenses or permits for five years. 

The regulations do, however, also include provisions to encourage innovation. For instance, authorizations will only be required for clinical trials on certain high-risk Class 3 devices, and will not be required at all for Class 2 devices; devices in both those classes with documented safety records can be exempt from clinical studies altogether.


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