NMPA (CFDA) published the “Guideline on Raw Material Change Evaluation of Non-active Device (Draft)” on June 27. Discussing design control, change control, Basic Safety and Effectiveness List, evaluation pathways, implications on Device Master File, and the necessity to submit new registration or renewal registration, the 25-page document guides manufacturers when non-active device raw material changes are made.
The NMPA Guideline on Raw Material Change emphasizes change control that “shall follow the risk management requirements of the quality management system, especially risk control and evaluation”. With 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:
It also lists the below 11 devices as example:
For the English version of “Guideline on Raw Material Change Evaluation of Non-active Device (Draft)”, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
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