The addition of a medical device to the packaging of a drug is clearly beyond the scope of the preparation process and packaging, the addition of medical devices and related instructions for use, warnings and other content, the impact of a wider range of quality, safety and use of risk, etc., should not be considered as an intermediate change.
In the drug registration management approach, the medium change mainly refers to the preparation process and packaging of the drug is different from the registered batch, but will not have a significant impact on the quality, efficacy, safety, do not need to provide new quality, efficacy, safety data and other changes.