On 19.05.2020, the NMPA (National Medical Products Administration) addressed the guidance notes (No.33-2020) for NMPA Legal Agents to formulate risk control measures due to the changes in raw materials used for manufacturing passive medical devices. With this guidance, NMPA Legal Agents should be in a better position to determine if it is necessary to apply for registration approval for the changes.
According to the guidance notes, the NMPA Legal Agent is responsible to evaluate and determine if the raw material changes would initiate any biological hazards, as well as consider whether there will be an impact to the chemical properties and physical performance of the parts or the medical device itself.
The common changes in the raw materials include, but are not limited to the following:
- Change of the type;
- Change of the composition and ratio; and
- Change of the preparation process.
The NMPA Legal Agent should always formulate an effective risk control plan and evaluate the effectiveness of the risk control measures. After taking risk control measures, any remaining risks should be evaluated using the criteria as specified in the risk management plan. If the residual risk is considered to be unacceptable, further risk control measures or risk-benefit analysis should be taken until the raw material has been accepted or rejected.
This guidance document does not act as an enforced regulation, and does not stipulate whether registration review and approval is required for material changes.
By Jacky Li. Contact Cisema to learn more.