Medical devices are classified by the CFDA in three different categories. The three classifications are marked Class I, Class II and Class III. Each category may require specific administrative procedures, product testing and / or even clinical trials.
- For Class I devices, safety and efficacy can be ensured through routine administration, so that product testing and clinical trials in China are usually not required.
- For Class II devices, safety and efficacy can be ensured through routine administration and product testing. Some devices also require clinical testing to gain regulatory approval for the Chinese market.
- Class III devices implanted in the human body or used to support or sustain life pose a potential risk to the human body and are strictly controlled through mandated tests and clinical trials to ensure safety and efficacy.
The cost and timeframe required for the CFDA registration of a product varies among the three different categories of medical devices (Class I, II or III). Even with the same classification, costs can vary widely depending on factors.Other factors that affect costs and timeframe:
- Number of products to be tested.
- Need to implement corporate or product standards.
- Scope of advice required for the labeling of the product (s).
- Prerequisite for an after sales agent or support in China.
- Amount of product documentation needed for language translation.
- Scope of product testing to Chinese GB standards.