Packaging for non sterile product

The type of medical device determines the conditions under which it must be manufactured. This is not prescribed anywhere. So it is up to the manufacturer to set requirements for environmental conditions in production. In ISO 13485: 2016, requirement 6.4.1 states that manufacturers must document requirements for the work environment need to achieve conformity of product requirements, especially if conditions may affect product quality.

From your example, you need to define what is controlled environment, how you will prove that these criteria for a controlled environment are met. For example, it can be temperature monitoring, humidity monitoring, regular cleaning process, disinfection, microbiological cleanliness of premises, and so on.