Sterilizers do not enter the hospital sales need to apply for a medical device registration certificate? Application for quality system assessment need to submit test reports?

No, first of all, you need to have enterprise production standards, its standards must meet or exceed the national standards, if there is no national standards, first of all, to develop enterprise standards. It is best to ask a professional review body or agency to help you apply for the quality system assessment, the Technical Supervision Bureau, there are specialized sub-units for the enterprise services.