Can individual businesses apply for China NMPA certification?
分类:行业新闻 发布时间:2024-08-19 15:33:38
Individual businesses need to ensure they adhere to these standards and work closely with regulatory consultants if necessary to navigate the certification process.

Yes, individual businesses can apply for China NMPA certification. However, they must meet specific requirements:

  1. Legal Entity: The business must be a legally registered entity, either within China or through a foreign-invested enterprise (FIE) in China.

  2. Compliance: The business must comply with all relevant Chinese regulations, including those for quality management systems and product safety.

  3. Documentation: The business must provide comprehensive technical documentation, including details on manufacturing processes, quality control, and safety data.

  4. Facility Standards: For manufacturers, the production facility must meet NMPA's requirements for good manufacturing practices (GMP).

Individual businesses need to ensure they adhere to these standards and work closely with regulatory consultants if necessary to navigate the certification process.

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