The CFDA (China Food and Drug Administration) is the highest administrative authority responsible for the registration and certification of medical devices and medical devices. It belongs to the Chinese Ministry of Health (MOH), the administrative body responsible for all medical health care in China.
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.
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.
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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.
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While Class I medical device approval typically takes 6-9 months, Class II medical device approval takes 10-12 months; Class III medical device approval may often take 12-18 months or more due to the clinical trial. The complexity of the device, its use, and its risks determine the cost and time of the approval.
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