Section 16. Systems and procedure packs Overview or procedure pack’ is a term used in the legislation to identify products that are packaged together for a ‘System specific intended purpose. Such a package must include at least one medical device but it can also contain medicines, other therapeutic goods (OTGs), and non-therapeutic goods. A group of products packaged together that meets the definition of or procedure pack’ is considered to be a medical device for the purposes of ‘system the Act. Other groupings of therapeutic products, such as therapeutic kits and composite packs, are also discussed in this section. The term and the term pack’ are used in order to accommodate different types of packages ‘system’ ‘procedure that contain medical devices. Additionally, some manufacturers might use the term pack’ for a ‘procedure particular collection or combination of products (for example, a collection of therapeutic goods for an appendectomy surgical procedure) while other manufacturers might refer to the same collection of therapeutic goods as a system. Nevertheless, no regulatory distinction is made between the two terms. The regulatory requirements are the same regardless of whether the package of goods meets the definition of or meets ‘system’ the definition of pack’ or meets the definitions of both. ‘procedure The term is used to describe an individual item in a system or a procedure pack. ‘component’ A system or procedure pack does not consist of: An individual item only A collection of miscellaneous items that are not intended by the manufacturer to be used for a specific purpose Bulk packs of one or more items
Section 16. Systems and procedure packs Overview ‘System or procedure pack’ is a term used in the legislation to identify products that are packaged together for a specific intended purpose. Such a package must include at least one medical device but it can also contain medicines, other therapeutic goods (OTGs), and non-therapeutic goods. A group of products packaged together that meets the definition of ‘system or procedure pack’ is considered to be a medical device for the purposes of the Act. Other groupings of therapeutic products, such as therapeutic kits and composite packs, are also discussed in this section. The term ‘system’ and the term ‘procedure pack’ are used in order to accommodate different types of packages that contain medical devices. Additionally, some manufacturers might use the term ‘procedure pack’ for a particular collection or combination of products (for example, a collection of therapeutic goods for an appendectomy surgical procedure) while other manufacturers might refer to the same collection of therapeutic goods as a system. Nevertheless, no regulatory distinction is made between the two terms. The regulatory requirements are the same regardless of whether the package of goods meets the definition of ‘system’ or meets the definition of ‘procedure pack’ or meets the definitions of both. The term ‘component’ is used to describe an individual item in a system or a procedure pack. A system or procedure pack does not consist of: An individual item only A collection of miscellaneous items that are not intended by the manufacturer to be used for a specific purpose Bulk packs of one or more items
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