The State Council of China passed amendments to the Regulations on Supervision and Administration of Medical Devices which came into effect on June 1, 2014. The amendments present significant regulatory changes that will impact the manufacturing, distribution, importation, clinical trials and product liability of the medical device industry in China. A summary of these key amendments are set out below.
Classifications Tied to Level of Risk
The amendments retain the concept of having three classes of medical devices: Class I, II and III. In addition to the prior requirements, these classifications are now tied to the level of risk associated with each medical device. Class I includes medical devices with 'low risk', Class II includes those with 'moderate risk' and Class III involves those with 'relatively high risks'. In determining the level of risk and classification of each medical device, the State Food and Drug Administration (SFDA) look to factors such as the intended purpose of the medical device, its structural features and applications.
Record Filing Instead of Registration
The amendments simplify product registration procedures and introduce documents that are necessary for filing and approval in order to secure medical device registration certificates.
Notably, a Class I medical device will no longer require approval from the CFDA. Instead, prior 'record-filing' with the CFDA’s local counterparts is required. This amendment also applies to the importation and distribution of foreign manufactured Class I medical devices. Approvals remain necessary for Class II and III medical devices and clinical trials may now be exempt within these classes. It is also no longer necessary to update product registration due to a change of manufacturing address, which may have implications for contract manufacturing.
A medical device registration certificate is now effective for five years instead of four years. An extension as opposed to a re-registration may now also be applied for six months prior to expiry of a registration certificate.
Under the amendments, product registration for Class II and III medical devices can now be completed before an application for a manufacturing certificate is made. Previously, the manufacturing certificate must be applied for before product registration can be completed, which may have meant an upfront capital commitment.
The amendments impose higher standards for a corporate qualifying to be a medical device manufacturer. In particular, a qualifying manufacturer must now have quality assurance systems in place, after sales service capabilities, and meet the relevant research and development standards as well as manufacturing processes.
It remains unnecessary to have a distribution license for Class I medical devices. A medical device distribution license, however, is no longer required for distributing Class II medical devices.
The amendments add provisions dedicated to monitoring adverse post-registration events, product re-evaluation and recall, and provide stricter rules for non-compliance. For example, administrative fines for manufacturing or distributing unregistered Class II or III medical devices are up to 20 times the value of a medical device itself.