Class I MD Filing
- Time of issue:2021-06-09 14:40:57
Medical device filing means that the medical device filing person submits the filing materials to the NMPA (National Medical Product Administration), and the NMPA files the submitted filing materials for reference.
For overseas production enterprises that export Class I medical devices to China, their representative offices established in China or designated corporate legal persons in China shall be their agent, and submit the filing application materials to NMPA.
1.Product risk analysis data
2.Product technical requirements
3.Product inspection report
4.Clinical evaluation data
5.Product manual and label samples
6.QMS documents related to product development and production
7.Other information required to prove the product is safe and effective
➣NMPA administrative fee: none
➣Estimated Timeline: acceptance on spot
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The company specializes in medical device registration, in vitro diagnostic reagents registration, cosmetics agent service company, committed to the NMPA, CE regulation research and product registration and certification service has been more than 17 years.