Understanding the CFDA
From October 2014, the China Food and Drug Administration (CFDA) enforced a number of new regulatory reforms regarding the registration of medical devices in China. Their reasons for doing this were three fold: for one, their aim was to create a more level playing field for domestic and foreign players, since previous to this change, all domestic Class II and III devices required clinical trials but most imported devices unfairly did not. Second, through these reforms, the CFDA was able to prioritise its workload by focusing on higher risk devices, requiring Class I products, for example, to be filed on record only, streamlining the process. Thirdly, the reforms encouraged the improvement of technical standards and increased transparency of the registration process.
While in theory the regulatory reforms were a positive change, they also present a number of challenges for companies planning to bring their medical devices to China. The CFDA now requires long clinical trials for a number of products, which can draw out the registration time substantially. Moreover, the amount of mandatory documentation applicants must submit has increased significantly in complexity and amount. This, coupled with noticeably higher fees, make the decision to register a much more serious process.
Given this complex and costly exercise, it is crucial to find a suitable advisor that can help with the registration procedures. To give you some insight into what is expected, you can find the key steps below so you can prepare accordingly if you want to take the next step in bringing your medical devices to China.
Example: Class III CFDA Registration
|1. Compile technical requirements||Registration Agent||1 month|
|2. Conduct testing||Approved testing centre||3 – 6 months depending on type|
|3. Translation of documents||Appointed official translator||2 – 3 months, can be done parallel to step 2|
|4. Conduct clinical trials, i.a.||Approved hospitals||1 year or more|
|5. Technical review||CFDA||150 working days for 2 cycles|
|6. Administrative approval||CFDA||30 working days|
First, we recommend to begin with a thorough analysis of the registration requirements, such as the classification (Class I, II, or III), number of applications required for the portfolio, and whether or not clinical trials are needed. At this stage, it makes sense to establish a project plan with the agent. Keep in mind that several registrations per set of devices might be required, as is the case for example for dental implants. Your agent must be able to compile a list of technical requirements and testing standards for your portfolio.
Testing and clinical trials precede the CFDA registration application and can be done in one of a handful of testing centres across the country. Beware that choosing the right one with suitable facilities and available capacity is an important decision! Only a few established agents are able to directly manage the clinical trial process, while most outsource it. Additionally, distributors are often involved in the clinical trial process, as they have access to Key Opinion Leaders (KOLs), such as medical doctors and other experts. To save time, we recommend the preparation and translation of the registration documents to be done concurrently to the testing process.
More likely than not, after the technical review which takes 90 working days, the CFDA will issue a notice for supplemental information, which will take another 60 working days. If the device is highly innovative or of high risk, an expert panel review may be required, which will add another 3-6 months to the process. In addition, locally producing companies will have to undergo a Quality Management System (QMS) audit at this stage.
All in all, the registration procedure is a lengthy and costly process that can take up to several years if companies fail to submit the required information and necessary documentation in time. Working with someone who is experienced in dealing with the CFDA and is up-to-date with the current requirements is essential in increasing the chances of success.