Is it necessary to submit evidence of sales in the Chinese market?
分类:行业新闻 发布时间:2024-11-13 11:50:47
In summary, while evidence of previous sales is not usually a requirement for initial certification, providing additional data related to market acceptance can potentially enhance the application.

When applying for the certification of traditional Chinese medical equipment products with the National Medical Products Administration (NMPA) in China, it is generally not a requirement to submit evidence of prior sales in the Chinese market. However, there are some important considerations to keep in mind:

  1. First-time Application: If the product is new or being introduced to the Chinese market for the first time, evidence of previous sales may not be necessary.

  2. Market History: If the product has been sold in other markets, manufacturers may choose to provide sales evidence or market acceptance data to strengthen their application, particularly if they argue for the product's safety and efficacy based on its performance outside of China.

  3. Clinical Data: Instead of sales data, the NMPA focuses more on clinical evaluation data or other evidence supporting the safety and effectiveness of the device. If clinical trials have been conducted or if there is existing literature supporting the product, this is typically more critical for the application.

  4. Post-market Surveillance: After obtaining certification and entering the Chinese market, manufacturers may be required to monitor the product's performance and report sales outcomes, adverse events, or other market feedback as part of their post-market obligations.

  5. Consultation: It can be beneficial to consult with local regulatory experts or legal advisors familiar with NMPA procedures to ensure compliance with current requirements and to understand what documentation might be advantageous for the application process.

In summary, while evidence of previous sales is not usually a requirement for initial certification, providing additional data related to market acceptance can potentially enhance the application.

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