1, product application form: fill out the product application form, and make sure to provide accurate and complete information.
2, product technical documents: including product manuals, technical specifications, product development and production of relevant documents.
3, product design drawings: provide product design drawings and process flow diagrams.
4, product performance verification data: including product performance testing, clinical trial data, safety evaluation reports.
5, quality management system documents: provide quality management system documents in line with relevant certification standards (such as ISO13485).
6, the manufacturer's qualification certificate: provide the relevant production license, business license, etc..
7, the relevant certification documents: such as CE certification, FDA approval documents.
8, the original equipment manufacturer (OEM) agreement: If the products of other manufacturers as the original equipment manufacturer for secondary sales, you need to provide the cooperation agreement with the original equipment manufacturer.