On May 19 2020, China NMPA implemented the "Guideline on Raw Material Change Evaluation of Non-active Device" 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. The following is considered as raw material changes:
- Type of raw material
- Material composition/ formulation ratio
- Processing method of the materials
- Other changes (Raw material supplier change, change in raw material grade, surface modification treatment, etc.)
Other key areas includes feasibility and effectiveness of the control measures implemented for the identified risks, specific contents of raw material changes, biological evaluation, etc.
What is your experience in handling raw material changes in China, US or EU? We'd like to hear your cases and opinions particularly relating to US FDA practices. China NMPA does factor in best practice from FDA and EU. So if there are areas you see that you think China is overly burdensome, please feel free share those or drop me an email.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------