Medical devices packaged together
Fact sheet no. 27
1. The different types of packs
There are four different ways in which therapeutic goods that are packaged together for supply are regulated under the Therapeutic Goods Act 1989 (the Act). These are:
- kits (regulated as therapeutic devices) prior to October 2002;
- procedure packs (regulated as medical devices);
- systems (regulated as medical devices); and
- composite packs (regulated as medicines).
1.1 Kits
Kits are therapeutic goods packaged together and contain a variety of different goods (one of which is a device), and were entered on the ARTG as therapeutic devices prior to the implementation of the medical devices legislation on 4 October 2002. These kits may continue to be supplied under that ARTG entry until October 2007.
If these kits are to be supplied after 4 October 2007, the sponsor needs to submit an application for the kits to be assessed against the medical devices regulatory requirements and re-entered onto the ARTG as "included medical devices", before the end of the transition period on 4 October 2007.
1.2 Procedure packs
Procedure packs are medical devices consisting of components packaged together (at least one of which is a medical device), and are intended by the manufacturer to be used in a medical, surgical or diagnostic procedure. Examples include surgical procedure packs, wound dressing packs and first aid kits included on the ARTG after October 2002.
The individual components of these procedure packs require a separate entry on the ARTG if they are supplied as separate items to the procedure pack.
The manufacturer must apply Conformity Assessment Procedures before the Australian sponsor can submit an application to the TGA for inclusion on the ARTG.
Some procedure packs may be eligible for the special Conformity Assessment Procedures if:
- the manufacturer of each component has already applied Conformity Assessment Procedures to the component; and
- the component is compatible with the other components in the procedure pack.
Procedure packs that contain medical device components that are listed or registered on the ARTG are also currently eligible for the special Conformity Assessment Procedures. However, eligibility ceases as soon as those listings or registrations cease on 4 October 2007. The component manufacturer would then need to have performed an appropriate Conformity Assessment Procedure for the component.
1.3 Systems
Systems are medical devices that are comprised of components that are intended, by the manufacturer, to be used in combination as a unit. Examples include Orthopaedic drill systems; Joint replacement systems, and Patient monitoring systems.
Although systems are different to procedure packs they are regulated using the same processes and procedures.
1.4 Composite packs
Composite packs only contain medicines and their containers and are entered onto the ARTG as medicines. Composite packs are used for a single treatment or a single course of treatment. The components must either be combined before administration or be administered in a particular sequence. Examples of composite packs include prefilled syringes and vials of medicines administered in a sequence.
2. Conformity assessment procedures
Manufacturers of medical devices use Conformity Assessment Procedures to demonstrate that their medical devices conform to the Essential Principles of safety and performance.
Depending on the classification of the medical device the Conformity Assessment Procedures may need to be audited by the TGA or another appropriate Conformity Assessment Body.
2.1 The special conformity assessment procedures
The special Conformity Assessment Procedures apply under Paragraph 3.10(3) and Part 7.5 of Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).
The special Conformity Assessment Procedures can be used for systems and procedure packs if:
- all of the medical device components have had the relevant Australian Conformity Assessment Procedures applied to them; or
- they are listed or registered on the ARTG (this option ceases on 4 October 2007); and
- medicines and other therapeutic goods (i.e. not medical devices) in the system/ procedure pack are on the ARTG; Note: Non-therapeutic goods may also be in the system/ procedure pack;
- all components are mutually compatible with:
- the intended purpose of each device,
- the approved indications for medicines, and
- the intended purpose of the system / procedure pack; and
- the manufacturer has made a declaration of conformity to Australia's regulatory requirements.
If the criteria for the special Conformity Assessment Procedures cannot be met, the manufacturer must apply the normal Conformity Assessment Procedures under Regulations 3.4 to 3.9 and 3.11 of the Regulations.
For further help refer to the guidance document "Conformity Assessment Procedures" <http://www.tga.gov.au/docs/html/devguid3.htm>.
2.2 Declaration of conformity
The manufacturer must make a declaration of conformity, whether performing the special or other Conformity Assessment Procedures.
For further help refer to the guidance document "The Declaration of Conformity" <http://www.tga.gov.au/docs/html/devguid5.htm>.
3. Different systems/procedure packs
3.1 Systems or procedure packs supplied sterile
If a system / procedure pack is to be supplied sterile, the manufacturer must follow the manufacturing processes in the quality assurance procedures in Part 4 of Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (medical devices regulations).
The manufacturer may then also apply the special Conformity Assessment Procedures for the sterile systems/procedure packs.
If the sterile system/procedure pack contains a medicine, the sterilisation method must be appropriate for the approved indications for the medicine and the additional sterilisation process must be taken into account in the initial approval of the indications for the medicine.
3.2 Class III and AIMD systems/procedure packs
If a system/procedure pack is classified as a class III medical device or an Active Implantable Medical Device (AIMD), each model of the system/procedure pack needs to be included on the ARTG at the unique product identifier level.
These applications will be subjected to a Level 2 application audit by the TGA - unless the manufacturer has an appropriate TGA Conformity Assessment Certificate.
3.3 Systems/procedure packs containing tissue of animal origin or integral medicine
Conformity Assessment Certification by the TGA is required for any component of a system or pack containing:
- tissues of animal origin that have been rendered non viable (other than those that are intended to contact intact skin only), or
- tissues, cells or substances of microbial or recombinant origin, and are intended for use in or on the human body, or
- stable derivatives of human blood or human plasma, or
- a medicine that is integral to the component, and the primary function is that of a device.
This means that manufacturers of these devices, whether in Australia or overseas, need a Conformity Assessment Certificate from the TGA before these goods can be considered for inclusion on the ARTG. An application may be made for a component or for the system or procedure pack.
Conformity Assessment Certification from the TGA is also required for the component if the component manufacturer is Australian and the component is higher than Class I, has a measuring function, or is sterile.
Once the Conformity Assessment Certification is obtained for the component, then the special Conformity Assessment Procedures can still be applied to the system/procedure pack itself.
3.4 Systems/procedure packs containing distinct medicine(s)
If a system/procedure pack contains a distinct medicine, the medicine is not considered when classifying the system/ procedure pack. However, distinct medicines that are incorporated in a system or a procedure pack must meet the regulatory requirements for the medicine. The systems/procedure packs containing medicines must also satisfy the labelling requirements for the medicine.
3.5 Systems/procedure packs not requiring a Conformity Assessment Certificate
A Conformity Assessment Certificate is not required for procedure packs:
- classified as Class I that are not supplied in a sterile state or do not contain a component that has a measuring function;
- approved for special or experimental use;
- approved for supply by a medical practitioner, or
- that are non-sterile and qualify for the special Conformity Assessment Procedure.
4. Issues to be considered
4.1 Classifying a system or a procedure pack
When classifying a system/procedure pack check:
- the appropriate Conformity Assessment Procedures have been selected;
- the component manufacturer's intended purpose and classification applies. By changing or limiting the component manufacturer's intended purpose or classification, the system/procedure pack manufacturer assumes responsibility for the component - invalidating the special Conformity Assessment Procedures;
- the component with the highest risk classification has determined the overall classification for the system/procedure pack , eg a procedure pack containing a class III device will also be class III;
- a system/procedure pack intended to be used in combination with another medical device, needs to be classified separately to that other medical device;
- any accessories are classified separately;
- the software used to drive or control a system has the same classification as the system;
- that when two or more classification rules can be applied the highest classification rule applies.
For further help refer to the guidance document "Classification of medical devices" <http://www.tga.gov.au/docs/html/devguid25.htm>.
4.2 Labelling requirements
In addition to the information required in Essential Principle 13, in Part 2 of Schedule 1 of the Regulations, systems and procedure packs must include the instructions for use for each component, as provided by the component manufacturer/s.
4.3 Documentation
The manufacturer of a system / procedure pack that is eligible for the special Conformity Assessment Procedures must
- hold evidence of eligibility for all component medical devices:
- component manufacturer's Australian declaration of conformity or TGA conformity assessment certificate or
- component manufacturer's CE certificate and supply agreement with the component manufacturer or
- ARTG inclusion certificate and supply agreement with the component sponsor;
- hold copies of the ARTG inclusion certificate for all component medicinal products and other therapeutic goods;
- have access to any technical documentation, including the component manufacturer's declaration of conformity, certification and technical documentation, for the lifetime of the device and at least 5 years; and
- provide those statements and documentation to the TGA on request.
4.4 Information required by the TGA
All Conformity Assessment Procedures require the manufacturer to establish a post-market surveillance system to:
- systematically review experiences gained after the device was supplied in Australia;
- implement corrective action, commensurate with the nature and risks involved with the medical device; and
- notify the sponsors of the medical device of adverse events and near events.
Sponsors have obligations to:
- collect information from users about incidents and the performance of devices and send this information to the manufacturer;
- report details of certain incidents and performance issues to the TGA; and
- maintain distribution records.
For details regarding the postmarket requirements, including reporting mechanisms, criteria and timeframes, refer to the guidance document "Postmarket activities" <http://www.tga.gov.au/docs/html/devguid11.htm>.
4.5 Changes or variations
If the contents in a system / procedure pack change, the manufacturer needs to:
- reassess the classification;
- reassess eligibility for the special Conformity Assessment Procedures;
- apply appropriate Conformity Assessment Procedures;
- assess whether the change requires TGA assessment or notification;
- update documentation, including the declaration of conformity; and
- determine if the change is covered by the scope of existing ARTG inclusions (eg GMDN code). If not, a new device application will be required.
Disclaimer
This document is provided for guidance only. It should not be relied upon to address every aspect of relevant legislation. Please refer to the Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Medical Devices) Regulations 2002 for legislative requirements.
Further information
The Medical Devices Information Unit of the Office of Devices, Blood and Tissues of the Therapeutic Goods Administration (TGA) can be contacted by:
Telephone: 1800 141 144
Facsimile: (02) 6232 8299
Email: cab.medical.device.information@tga.gov.au
Website: www.tga.gov.au/devices/devices.htm
Mail: PO Box 100, Woden ACT 2606
© Commonwealth of Australia 2007