On 7 March 2014, China's State Council promulgated the new Medical Device Supervision and Administration Regulations (the "Regulations"). The Regulations, which came into effect on 1 June 2014, contain some significant changes covering product and manufacturing approvals, clinical trials, operation and use of medical devices, sale and advertising and monitoring of adverse events. Some of these changes are set out below:
Classification of Medical Devices and Registration Requirements
Medical devices are classified into 3 Classes- Class I, II and III. Class I devices (whether or not manufactured in China) can be sold in China after recordal with the city FDA. Class II and III devices can be registered with the provincial and CFDA respectively. Product licences are valid for 5 years.
Clinical trials and the manufacture of medical devices
Class I medical devices i.e. low risk devices do not require clinical trials. Clinical trials are, however, required for Class II and III devices but there are statutory exemptions, such as where the safety of such devices can be proved through non-clinical evaluation or by clinical trials conducted on the same categories of medical devices. Having said that, the Regulations remain silent as to whether foreign clinical trials will be acceptable.
Class III devices, requiring clinical trials will still require the necessary approvals.
The Regulations no longer require companies to obtain a manufacturing licence before registering Class II and III devices, provided that the relevant GMP requirements have been complied with during product design and development. This is a welcome change as the previous system required a manufacturing licence to be given in support of the product licence.
Manufacturing licences are valid for 5 years.
Post-marketing surveillance and onsite inspection
The CFDA will establish a monitoring system to deal with adverse events and product recall. Every medical device company should also establish a system to monitor and report any adverse event. The CFDA is empowered to conduct on-site inspection, documentation examination, product seizure and other activities.
Escalated penalties for non-compliance
The Regulations contain notable increases on the liabilities and penalties for manufacturers. For example, penalties for offences such as unlicensed manufacturing or manufacturing of unlicensed products can be up to 20 times the value of the products, and companies may be barred from applying or renewing the relevant licence for up to 5 years.
Supplementary Administrative Measures
To support the implementation of the Regulations, the CFDA also formulated and revised five Administrative Measures, which were promulgated on 30 July 2014 and will be effective from 1 October 2014.
- Administrative Measures for Medical Device Registration;
- Administrative Measures for the Registration of In Vitro Diagnostic Reagents;
- Administrative Rules for the Instructions and Labels of Medical Devices;
- Administrative Measures for the Supervision of Medical Device Manufacturing;
- Administrative Measures for the Supervision of Distribution of Medical Devices.
All medical device companies operating in China should carefully consider the implication of the Regulations and the Administrative Measures to ensure that their operations are in line with these new requirements.