Can medical devices sterilize their own packaging

The act requires approval and filing.

According to the Shun enterprise network shows that the high level of disinfectants and disinfecting instruments used for medical devices, has a high risk and requires strict management to ensure safe and effective disinfection products. Sterilization products need to be approved and filed regulations, the provisions are as follows:

1, the need for administrative approval (i.e., often referred to as the approval of the consumer name).

2, need to obtain a safety evaluation report for the record voucher. Sterilization products need to do a good job of safety evaluation reports, and to the provincial health department for the record and obtain the record voucher (the implementation of the provinces will be different).

Requirements for the record: the first time the product is listed, the product should be responsible for the unit of health and safety evaluation report to the local provincial health department for the record. By the provincial health department for health and safety evaluation report for formal review.