In the last 15 years, local clinical trials were almost never required to register a high-risk imported medical device in China, even for the most risky devices. Foreign clinical data from the United States or European Union would normally suffice, and registration was a lot simpler.
However, this all changed in October 2014, when the newly released Chinese medical device regulations by the China Food and Drug Administration (CFDA) stated that more and more local clinical studies would be needed to register your device in China. Today, some class II devices and almost all class III devices require local clinical trials to obtain product registration approval. The only exception is if your device is on an exemption list.
The heightened requirement for local clinical trials means that many device companies in the West now face significantly higher costs to do business in China. This is in addition to the higher user fees that the CFDA is now charging to review your dossier. Beyond the cost, the additional time frame to do such clinical trials will slow the registration process by at least one year.
In May 2015, the CFDA announced that in lieu of local clinical trials, some foreign device companies could present a clinical evaluation report (CER) showing that their product was significantly similar to predicate devices already approved in China. Since the new regulations on CER have come out, many Western device companies have asked me how they can do CERs as a way to avoid local clinical studies.
While I was in China in November, I asked our China team and other key regulatory affairs affiliates we have there about CERs. To my knowledge, there have been some CERs submitted to the CFDA but no replies saying that local clinical trials will be waived yet, though this may change in the near future. What I learned was that no one is really sure whether CERs will work either in the industry or at the CFDA. Many of our regulatory colleagues claim that these CERs would never suffice in the place of local clinical trials, but one or two others say that the CER may work and save foreign device companies the cost and time to do a local clinical study in China. It seems that the jury is still out on whether the CERs will help some Western device companies avoid local clinical trials for product registration in China.
To demonstrate that your new device has an approved predicate for the CER is most feasible if your new product is an upgraded version of your old product that is approved and being sold in China already, with the same use and application. Using your previously registered devices in China may be the easiest way to find success with CERs.
Of course, there are plenty of foreign device companies with similar devices that do not have a predicate device approved in China, so what else can a device company do? One colleague suggested that if this is the case, then you need to compare your product to a similar approved device from another company in China. To do this, you may need to purchase the competitor’s approved products in China and do your own testing to show that your products are very similar to the already approved products. I am not sure what local tests will suffice for this type of CER comparison, but some seem to feel that this strategy may work.
Of course, as usual, the Chinese regulations are always evolving, so it is unclear exactly what to expect about CERs at this point.