On March 31, 2014, the Chinese government released a revised version of the “Regulations on the Supervision and Administration of Medical Devices.” These regulations were approved by the State Council on February 13, 2014 and will officially go into effect June 1, 2014. First released in 2000, Chinese regulators have been working on revising the Chinese medical device regulations since 2006. The China Food and Drug Agency (CFDA) has also announced that it will release more than 30 supplemental implementation rules throughout 2014.
One of the key revisions is in expanding the definition of medical devices. The following product categories will be included: appliances, instruments, apparatuses, in vitro reagents and calibrators, materials and related articles, including any software necessary. The previous definition of medical devices was vague on the topic of in vitro diagnostic (IVD) devices; the new definition is more specific regarding what will be considered a medical device. Furthermore, the therapeutic purposes of devices have also been expanded to include devices having an intended purpose of life support or maintenance or an intended purpose of information collection for treatment or diagnosis through human sample testing.
Another important change is in device classification. Based on product risk — as opposed to a list based system — devices will be assigned to Class 1 (low), 2 (intermediate) or 3 (high). This also simplifies the registration and marketing authorization processes. Class 1 devices will not need prior CFDA or provincial FDA registration or approval before marketing. Instead, the manufacturer only needs to file a notification with the relevant local FDA. This applies to both domestically produced and imported Class 1 devices.
CFDA pre-market review and product approval of Class 2 and Class 3 devices will still be in place. However, it will not be necessary to receive prior approval to distribute Class 1 or Class 2 medical devices. Distributors of Class 2 devices should submit notification documents — detailing the start of distribution of a product — to their local government office. While approval for distribution of Class 3 devices will be required, distributors can apply for this approval from local FDAs, instead of the provincial FDA. Labeling and packaging regulations are also being updated.
The new rules further increase requirements for compliance with good manufacturing practices (GMP) and good supply practices (GSP). Manufacturers of medical devices in China will be required to run facilities that are GMP compliant and to provide self-evaluations of GMP compliance to their provincial FDA. Local manufacturers of Class 2 and Class 3 devices will need to receive approval before applying for a medical device production license.
Distributors need to be put in place enhanced GSP compliant systems. Class 2 and Class 3 device wholesalers, as well as Class 3 device retailers, must keep all sales records for at least 5 years after the device is no longer in use. Medical institutions will need to keep records of the medical devices they buy and use, too. Specific records and product numbers of implants and similar devices need to be maintained to ensure that these products can be traced in the event of a recall. The Chinese government will also develop a traceability system for high risk devices.
Some Class 2 and Class 3 devices that already have a proven record of safety based on clinical or non-clinical data — domestic or overseas — may not require clinical studies for approval. The CFDA will release a list of the device types that will be exempt from clinical trials soon.
In the post-market surveillance area, regulations and systems for monitoring adverse events, recalls and re-evaluation of devices have been reinforced — especially in terms of inspection and punishment. Greater emphasis and scrutiny will be given to post-market surveillance. Furthermore, local Chinese FDAs will be required to strengthen their oversight of a device firm’s post-market surveillance. Local FDAs will also receive investigational powers — and will be allowed to shut down manufacturing or distribution facilities if necessary.
Penalties for breaking the law have been expanded for both manufacturers and distributors. Companies that mislead regulators or manufacture or distribute unlicensed medical devices may face stiff punishments. These penalties could include:
- Confiscation of the products and production machinery
- Fines up to 20 times the value of the products
- Criminal charges
- Ineligibility to receive device permits or approvals for 5 years
Already, a variety of draft regulations providing further details on implementing these post-market surveillance laws have been released since March 31, 2014. So far, these have included rules on manufacturing, clinical studies, labeling, distribution and product registration.
Western companies that manufacture medical devices in China for the domestic market or import devices for sale in China should make sure they understand all of the changes in the revised “Administrative Regulation on Medical Devices” by the time the laws go into effect on June 1, 2014. Knowing these regulations will help prevent problems in the future.