For Non-active Medical Device Products With Sterilized Packaging, How To Submit The Performance Evaluation Data For Primary Packaging?

The administrative counterpart should evaluate the relevant performance of the primary packaging materials based on the effects of the product itself and the sterilization method on the primary packaging materials. It is recommended to consider primary packaging materials, packaging process, packaging methods, and compatibility of primary packaging materials with products as well as other aspects, such as product packaging integrity, packaging seal strength and similar performance evaluation which can affect resistance to bacteria during shelf life, whether there will be biochemical reactions between the packaging materials and the medical device, whether the reaction will affect the barrier properties of the packaging and/or the safety and effectiveness of the product, the challenges of the shape of the medical device to the primary packaging, etc.