In order to sell in the Chinese market your rehabilitation/assistive devices (herein after used interchangeably) device(s) must be registered, approved and classified according to the 3 classes mentioned in figure 3. The device registration must be done by a legal Chinese entity and in accordance with the China Food and Drug Administration (CFDA) procedures.
If you do not have a legal entity in China you are required to appoint a registered legal agent to handle your medical device registration. In addition you are required to appoint a local after-sales agent to manage maintenance and device issues.
One option would be to request that your distributor become your legal and after-sales agent. We strongly advise you not to do this because it requires you to give your distributor the rights of registration. This is risky because it gives the distributor too much influence over your business in China. Distributors also have limited experience in registering medical devices and mistakes made in the initial registration can lead to major problems when renewing the registration in the future.
We suggest working with an independent medical registration agency that possesses the right experience and relations to successfully register your medical devices. This solution poses fewer risks and can speed up the registration process significantly.
The 3 Classifications of Medical Devices in China
It’s important that foreign MNC’s, prior to entering the Chinese market, consider the approval time of the different classes of rehabilitation devices. Compared to Japan, the EU and the U.S., China has the longest approval time for each class of medical device. The approval time depends on the class, where class I takes the least time and class III the most. The majority of rehabilitation and assistive devices fall into class II and will take roughly around 6 months to fully register.
The Chinese government has recently (June 2014) put new regulations into effect with the goal of accelerating the registration process. Working with an agency which specializes in the registration of medical devices may also help speed up the registration process.
Medical devices are divided in to 3 classes in China according to risk: I, II and III with class I being the lowest risk and class III being the highest level of risk. Please note: the examples provided in the table below should not be regarded as a definitive guide and you should consult a medical registration agency before relying on these figures.
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