Recently in May, China NMPA issued a new Guidance Document for the Evaluation of Raw Material Changes in Non-active Medical Devices (hereafter called as “Guidance”). This guidance requires that when the raw materials used in non-active medical devices change, the registrant should fully evaluate the possible impact of the raw material changes on the medical devices, and reduce the risk to an acceptable range.
Registrant shall fully consider this Guidance in below situations:
- Changes in the primary packaging materials of non-active medical devices, and
- Changes in the raw materials of non-active components in active medical devices, and
- Changes in the characteristics of biocompatibility, physical, chemical, or expiration date of final products due to changes in production processes of non-active medical devices.
Registrant shall conduct a risk assessment according to the following process:
1. The registrant should determine whether the raw materials of the product have changed. This includes changes in raw material types, changes in material composition and/or ratio and changes in material preparation processes.
2. Identify all possible hazards (sources) or injuries caused by changes in raw materials.
3. Perform the verifications and assessments for each risk.
If the risk is evaluated as unacceptable, manufacturer shall take action to reduce or control the risk. The registrant should consider further verification through animal experiments, and a clinical evaluation if necessary.
NMPA also notifies manufacturers to consider this Guidance when signing an agreement with the material supplier.
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