NMPA implemented the “Guideline on Raw Material Change Evaluation of Non-active Device” on May 19, 2020. The guideline has gone through modifications since the draft feedback was released on June 27, 2019. The 22-page document guides manufacturers when raw material changes of non-active device are made. It discusses design control, change control, Basic Safety and Effectiveness List, evaluation pathways, implications on Device Master File, and necessity to submit new registration, renewal registration or conduct further clinical investigation.
What to Do When Changes Happened
The Guideline emphasizes change control that “shall follow the risk management requirements of the quality management system, especially risk control and evaluation”. With the regard to risk control, there must be an effective risk control plan and analysis of the effectiveness of the risk control plan (including validation/verification). After implementing risk control, additional risks should be evaluated through the guidelines of the risk management plan. the remaining risks are not applicable to the risk management plan, additional steps are required to ensure risk control measures and risk benefit analysis are carried out.
The Guideline contains the following raw material changes:
Other Highlights from the Guideline
Eleven Examples for Re-evaluation
The guideline lists eleven devices as example to demonstrate the raw material changes that can result in re-registration or further clinical evaluation:
We have translated the “Guideline on Raw Material Change Evaluation of Non-active Device” with the flow chart on how raw material changes trigger reevaluation. For an English copy please email info@ChinaMedDevice.com.