Will there be multiple certification and approval processes for NMPA registered medical devices in China?
分类:公司新闻 发布时间:2024-09-09 15:54:03
Each process aims to ensure that the device continues to meet regulatory standards throughout its lifecycle.

Yes, multiple certification and approval processes can be involved for NMPA-registered medical devices in China, depending on the nature of the device and the changes made:

  1. Initial Registration: This process involves obtaining the primary approval for the medical device, including technical reviews, testing, and inspections.

  2. Clinical Trials: For certain devices, especially Class III devices, clinical trials may be required to demonstrate safety and efficacy.

  3. Changes and Updates: Significant changes to the device or its manufacturing process require additional approval. This might involve submitting new documentation or undergoing further review by the NMPA.

  4. Renewals and Re-certifications: Periodic renewals of the registration might be necessary, involving updates to documentation and re-evaluation of the device.

Each process aims to ensure that the device continues to meet regulatory standards throughout its lifecycle.

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