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Submissions received: Proposed clarification of the regulatory requirements for medical device systems or procedure packs
The TGA thanks respondents who provided submissions in response to the public consultation paper Proposed clarification of the regulatory requirements for medical device systems or procedure packs.
The consultation was related to the implementation of the Australian Government Response to the Review of Medicines and Medical Devices Regulation (MMDR), in particular Recommendation 20, the regulation of medical devices in Australia, wherever possible, be aligned with the European Union (EU) framework.
A total of 16 submissions were received.
This consultation invited respondents to provide feedback on the proposed changes to the current regulatory requirements for medical device systems or procedure packs (SOPPs). The proposed changes apply to medical devices, including in vitro diagnostic (IVD) medical devices in Australia.
The proposed changes outlined in the public consultation paper were based on the EU regulatory framework and were intended to improve clarity and understanding of the existing Australian regulatory requirements for medical device SOPPs. By removing barriers to regulatory compliance, these changes are expected to improve the safety and performance of medical devices.
Specifically, the proposed amendments in the consultation paper were to:
- introduce definitions of system, procedure pack, and compatibility;
- clarify existing requirements for manufacturers of SOPPs that are medical devices used for a special purpose to include:
- holding evidence in the form of a conformity assessment document from the TGA, a comparable overseas regulator or assessment body for each medical device in the SOPP, obtained from the manufacturer of those devices;
- for SOPPs intended to be supplied sterile, ensure that the minimum conformity assessment procedure appropriate for ensuring the sterility has been applied, and ensure that sterilisation of the SOPP has been carried out in accordance with the instructions from all original manufacturers of all goods put into the SOPP;
- where the packaging of any goods is opened or modified and put into the SOPP – ensuring that a written agreement is in place with the manufacturers of the respective goods comprising the SOPP, verifying that the production step has been performed in accordance with the manufacturer's instructions and does not impact the performance of the goods; and
- consider the adequacy of the record retention requirements specified in clause 7.6 of the Therapeutic Goods (Medical Devices) Regulations 2002 relating to SOPPs using the special conformity assessment procedure pathway.
Further feedback was sought on whether there are any groups/categories of SOPPs (e.g. IVD systems, orthopaedic loan kits) that should be given particular consideration including comments regarding the transitional arrangements proposed in the consultation paper.
Summary of responses to proposals
The overall level of support for the proposed changes was positive with broad support for:
- the introduction of definitions;
- amendments to the existing regulatory provisions that apply to SOPPs using the special conformity assessment procedure pathway; and
- re-consideration of existing record retention requirements that apply to SOPPs using the special conformity assessment procedure pathway.
A range of industry respondents expressed some concerns with the proposals relating to:
- requirements for manufacturers of SOPPs that are medical devices used for a special purpose; and
- particular categories of SOPP such as orthopaedic loan kits.
One respondent expressed concern about first aid kits being categorised as medical device SOPPs. The TGA has since discussed this issue and will clarify in guidance, the regulatory requirements with respect to first aid kits.
All respondents, with the exception of two, supported the transitional arrangements proposed in the consultation paper.
Clarify existing requirements for SOPPs that are medical devices used for a special purpose
Some respondents expressed concerns with the proposal to require a written agreement to be in place with the manufacturers of goods, when the packaging of any goods placed in the SOPP have been opened or modified. Concerns related to the regulatory burden associated with this approach and the difficulty with obtaining these written agreements. Respondents requested an alternate option in lieu of a written agreement with the original manufacturer.
Other respondents requested clarity and guidance on what is meant by an acceptable conformity assessment document from a comparable overseas regulator for the SOPP manufacturer. Further clarity was also sought for the allowance of custom-made medical devices supplied through the exemption pathway to be included in SOPPs that are medical devices used for a special purpose.
Considerations for particular categories of SOPP such as orthopaedic loan kits
Some respondents raised concerns about the potential impacts including the lack of flexibility to meet surgeons' requests or costs to supply orthopaedic loan kits if the proposed regulatory reforms for SOPPs also applied to loan kits.
Following consideration of the public submissions, the TGA invited respondents to targeted workshops to discuss specific matters. In these workshops, respondents expressed:
- broad support for the proposition that loan kits should be regulated in a similar manner to other medical devices and not regulated as SOPPs that are medical devices used for a special purpose;
- support for other details relating to the regulation of loan kits to be addressed in guidance materials; and
- agreement that when the SOPP manufacturer opens or modifies the original packaging of any goods that comprise the SOPP, they assume responsibility for the safety and performance of the modified goods.
The TGA has considered the feedback received from the submissions and targeted stakeholder engagements and has prepared amendments for the regulation of SOPPs for Government consideration.
Comprehensive guidance material will be made available to provide information to stakeholders about what the proposed amendments will mean for SOPP manufacturers and sponsors, as well as further information about transitional arrangements.
Targeted stakeholder engagements has identified the need to develop guidance on requirements particular to loan kits, what constitutes as a conformity assessment document for a SOPP manufacturer and clarity on the interpretation of when SOPP manufacturer opens original packaging of any goods placed in the SOPP. Detailed guidance will be made available to stakeholders to assist clarify in more detail, the other issues raised in the submissions.
All submissions that gave permission to be published on the TGA website are available below in PDF format.
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- Consultation submission: AbbVie Pty Ltd (pdf,95kb)
- Consultation submission: Australian Dental Industry Association (pdf,905kb)
- Consultation submission: Kevin Samuels, Director of Quality & Regulatory ANZ
- Consultation submission: Mahesh Datar, Senior Regulatory Affairs Manager
- Consultation submission: Medicines Australia (pdf,556kb)
- Consultation submission: Minta Chen, Senior Regulatory Affairs and Quality Manager