For example, a class I device does not require clinical testing, if the manufacturer has complete testing equipment in addition to biological evaluation, can issue its own registration inspection report.
Class II devices, according to the risk level of the product and the SFDA and related regulations (CE, FDA, CMDCAS) to determine the requirements, some Class II devices can be exempted from clinical trials.
Class III devices are currently subject to clinical trials, and the design and development of Class III devices is the most rigorous.
The design and development of three types of active devices, for example, is generally divided into the following stages:
Design and development plan, design input, design review, design verification, design confirmation, design conversion, design changes, etc.
1, design input (regulatory requirements, performance requirements, environmental requirements, customer requirements, functional performance requirements, electrical safety requirements, use of the requirements, Environmental requirements, packaging requirements, risk identification, etc.
2, design output (product drawings, self-test report, biological performance evaluation report, basic performance checklist, clinical report, full performance test report for product registration, etc.)
Related output documents and records; DHR, DHF, DMR
Friends, the above is just a general summary. If you need a deeper understanding of product development, it is recommended to study ISO 13485 and FDA regulation Part 820-Quality system regulation. The above is for reference only!