China is one of the most attractive secondary markets for medical device manufacturers worldwide. The regulatory requirements mandated by the State Food and Drug Administration (SFDA) have been evolving.
The following overview of how to classify and register medical devices in China is provided by ChinaGate's Janice Ma.
Medical device classification
There are three classes of medical device in China:
- Class I: Those which safety and effectiveness can be ensured through routine administration.
- Class II: Those which further control is required to ensure their safety and effectiveness.
- Class III: Those which are implanted into the human body, or used to support or sustain life, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness.
Product registration types
There are two types of product registration: a new application and a license amendment. A lot of device companies view the Chinese registration process as difficult and complicated - often because "new applications" tend to apply to a broad range of situations.
For example, a change in manufacturing sites will be grounds for a "new" application because SFDA feels that the whole product QA system has changed. Similarly, adding new models or new accessories will cause an application to be considered new, especially if there are any technical changes which will affect product specification.
Another example is the situation of a pure software product that will be updated every three to six months. In practice that will mean that the minute you obtain approval for one version, you may already have updated your product to the next version and need to restart the whole application process.
For a successful device registration in China, manufacturers need:
- a clear understanding of China and the foreign regulations. When you know the requirements from both sides, you can be well prepared with your technical files and other documents.
- a robust strategy and a creative route to navigate SDFA's product registration processes. If China is strategically important for your company, spend time up-front, before you rush into any registration project in China.
- to appoint a professional and independent bilingual registration agent with broad experience. They should be capable of writing an accurate professional dossier, need to know how to select high-quality testing centers, must have good relationships with SFDA officials, and have experience with the organization of clinical trials and clinical data.
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