NMPA Guideline on Raw Material Changes for Non-active Devices: Eleven Examples

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:

1. Change in the type of raw material
2. Material composition/formulation ratio change
3. Change in the processing method of materials
4. Other changes (Raw material supplier change, change in raw material grade, surface modification treatment, etc.)

Other Highlights from the Guideline

1. To determine the appropriate change pathway, manufacturers shall first review the feasibility and effectiveness of the control measures implemented for the identified risks.
2. To determine which change it triggers, manufacturers shall obtain the specific contents of raw material changes. When the raw material composition information cannot be obtained under certain circumstances, further evidence may be provided through relevant standards and literature or appropriate chemical analysis. For the process, methods and requirements of chemical analysis. please contact info@ChinaMedDevice.com for relevant standards and guidelines.
3. For biological evaluation, manufacturers shall determine whether the changed material has direct or indirect contact with the human body, and evaluate if new biological hazards are caused by the change.
4. “Approved predicate device” means the device with same formula or chemical composition, and with same manufacturing process (including sterilization process). In addition, the physical properties of the device or component that undergoes a material change, the polymer curing time and other physical properties should also be factors for evaluation.

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:

1. Hollow fiber hemodialyzer
2. Facial implants
3. Balloon dilatation catheter
4. Vertebral fusion cage
5. Orthopedic surgical tool handles
6. Single use infusion set
7. Absorbable suture
8. Cornea contact lens solution
9. Color contact lenses
10. Acrylic bone cement for artificial joints
11. Silicone rubber breast implant

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.