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NMPA (CFDA) Guideline on Raw Material Changes: 11 Devices as Example

  • 1.  NMPA (CFDA) Guideline on Raw Material Changes: 11 Devices as Example

    Posted 17-Sep-2019 11:05

    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 Guideline 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:

    1. Change in the type of raw material
    2. Material composition/match 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.)

    It also lists the below 11 devices as example:

    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

    If you have any questions or want an English copy of "Guideline on Raw Material Change Evaluation of Non-active Device (Draft)", please leave comments below or email me at gpalma@ChinaMedDevice.com.



    ------------------------------
    Grace Fu Palma
    ChinaMed Device, LLC
    MA, U.S.
    gpalma@ChinaMedDevice.com
    978-390-4453
    www.ChinaMedDevice.com
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