CFDA: New and adjusted regulations for medical device registration announced

10. April 2014

As we previously wrote about in our “News” section on our website, the China Food and Drug Administration (CFDA, Chinese: 国家食品药品监督管理总局) announced (in February of 2014) that they would soon be publishing amendments to the Regulations for the Supervision and Administration of Medical Devices (Chinese: 医疗器械监督管理条例（修订草案）).

On March 31, 2014 the new regulations were officially published on the CFDA homepage. Unfortunately, the have only been published in the Chinese language for now. They will become effective as of June 1, 2014. Manufacturers of medical devices who consider to approve their products for the Chinese market, will be required to be in compliance with the new revisions.
Obviously, these amendments will affect the way that products will be certified going forward. One such difference will be in regards to clinical trials for Class II products, which will no longer be required. According to the new regulations, only Class III products with a high potential of risk to the health and/or safety of the patient will require clinical trials in the future. However – this cannot be assured as the authority will decide in every single case what exactly is required for CFDA approval.
Another change will be a heightened system of monitoring medical products, as well as stiffer penalties to manufacturers who are not in compliance with the requirements, or who accidentally or intentionally defy the rules. Although the CFDA will monitor all medical products they will of course put an emphasis on monitoring and controlling Class III “high risk” devices. There will be a three-pronged approach to assuring the safety of devices going forward:

• The first will be a monitoring system set up to keep track of adverse events, thus tracking the failures of devices, and keeping statistics
• Secondly, there will be a reappraisal mechanism that will go into effect when standards are compromised
• The last will be a recall, requiring all flawed devices to be withdrawn from the market and future shipments and sales halted. It will be at this stage that the CFDA will determine if any penalties will be levied

In addition, the penalties have increased substantially for all non-compliance, with special attention to medical devices deemed as “high risk (generally Class III).” Depending on the potential risk, penalties of up to 20 times the value of the medical device, as well as criminal charges are possible for manufacturers, distributors and buyers. The main goal is to stop the manufacturing, distribution and use of unregistered devices, as well as to quickly pull any unsafe devices out of the supply chain.
Applicants who have already started their approval process will be required to comply with the new amendments immediately. They are placed in a difficult position since they have quickly to adapt their ongoing certification process to the new regulations. This will delay the certification process, often resulting in higher costs for the manufacturer.
With the new amendments comes an increased liability for manufacturers of these devices.
It is important for manufacturers to stay current with the new Chinese regulations as they are announced, and to make adjustments when necessary to avoid non-compliance and potential penalties.
Future regulatory amendments are expected.