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.
Significance of Change Control
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.
What are the “Raw Material Changes”?
The Guideline contains the following raw material changes:
- Change in the type of raw material
- Material composition/match ratio change
- Change in the processing method of materials
- Other changes (Raw material supplier change, change in raw material grade, surface modification treatment, etc.
Device Being Impacted
It also lists the below 11 devices as example:
- Hollow fiber hemodialyzer
- Facial implants
- Balloon dilatation catheter
- Vertebral fusion cage
- Orthopedic surgical tool handles
- Single use infusion set
- Absorbable suture
- Cornea contact lens solution
- Color contact lenses
- Acrylic bone cement for artificial joints
- Silicone rubber breast implant
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ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.