Medical device sponsors may be selected to take part in the Medical Device Vigilance Program (MDVP) Pilot desktop audits (DTA) and on-site inspections (inspection). We will select participants after reviewing their Sponsor Vigilance Self-Assessment Tool (SAT) submission.
DTAs and inspections review the sponsor's documents, systems, and procedures. This is used to demonstrate compliance with the post-market requirements to:
- hold or obtain information to substantiate compliance (Essential Principles and Conformity Assessment Procedures), and
- receive, respond to, record, and report device related complaints, adverse events, and recall/non-recall actions.
These activities need good communication and clear processes between sponsors and manufacturers.
Not all sponsors who have completed the SAT will be selected to progress to a DTA and inspection. Selection is based on the TGA’s review of the SAT responses and other regulatory information. For the MDVP Pilot, a range of sponsor types (for example, new versus experienced sponsors, sponsors with different sized portfolios of entries in the Australian Register of Therapeutic Goods (ARTG), sponsors of various device classes) may be selected.
DTAs are scheduled to commence in late 2023, with inspections to follow in 2024. We will contact you if you are chosen to take part in the DTA and inspection stages. We will use the contact details in your SAT response or the TGA eBusiness Services (eBS) portal.
Remember to keep your contact details up to date on the eBS portal.
Desktop audit (DTA
We will send you a letter informing you on your participation in a DTA, and request information from you. Requests for information will be through section 41JA of the Therapeutic Goods Act 1989 (the Act). It sets a clear response timeframe.
You will have reasonable time, no less than ten working days, to provide the information.
You can submit your information to us via the SharePoint portal link we will provide you. The link will come with instructions.
We will review your documents and records and may ask for more information. At the end of this process, you will receive a DTA outcome letter that will summarise:
- what we requested and reviewed,
- whether you will progress to an inspection (outcome), and
- (as appropriate) information to help improve your understanding of the relevant post-market regulatory obligations.
We will contact you if you progress to an inspection.
Visit the MDVP Pilot webpage for updates and general feedback.
On-site inspection
An inspection will review your post-market systems, processes, and procedures.
We will inform you of your participation in an inspection as part of the DTA outcome letter. We will notify you at least four weeks before the planned inspection date.
The on-site inspection usually takes one working day. The size of your organisation, ARTG portfolio, and complexity of matters observed will determine how long it takes.
Preparing
You will receive an inspection announcement letter requesting pre-inspection information and notifying you of the inspection details.
Planning for the inspection is beneficial. This means:
- making sure you have relevant documents/records available,
- key staff are present, and
- contacting relevant legal manufacturers for any information you need.
What to expect
The inspection starts with an opening meeting, where we will discuss the inspection plan and make any required changes. Activities will then begin in line with the inspection plan.
Generally, we will:
- review how you receive, respond, record and report device events or incidents (including complaints, adverse events, and recall or non-recall actions),
- interview staff in your organisation, and
- examine your facilities.
At the inspection closing meeting, we will discuss observations and preliminary findings.
Inspection reports
We will provide an inspection report afterwards, summarising the feedback. If needed, we will request further information from you regarding any corrective actions taken to address feedback. To ensure timely responses, information will be requested under section 41JA of the Act.
An inspection proceeds to close-out once we are satisfied with your response.
Desktop audit and inspection outcomes
The DTA and inspection processes may uncover compliance deficiencies or non-compliances. This could be in your systems, documents, records, or practices.
We will first work with you to address any identified compliance deficiencies or non-compliances.
This can be through:
- providing you with guidance or examples of best practice where available, and
- requiring you to establish corrective action plans.
Powers to request information and inspect premises
In the MDVP Pilot, we will utilise powers listed in the Act.
Under section 41JA of the Act, we will request information from sponsors and set response deadlines. This is to ensure a timely response and prevent processing delays.
TGA Authorised Persons can enter sponsor premises to monitor regulatory compliance. Part 6-2 of the Act confers these powers.
It is also a condition of inclusion for a device in the ARTG to allow the TGA to enter and inspect a sponsor’s premises. This is under section 41FN(1) of the Act.
Compliance and enforcement
Medical device sponsors must comply with the post-market regulatory obligations.
Where there are significant issues of non-compliance, such as:
- failing to comply with the post-market requirements, or
- refusing or failing to comply with conditions of inclusion for ARTG entries,
the TGA can take regulatory action, like:
- suspend or cancel medical devices from the ARTG (Part 4-6 of the Act),
- impose infringements, civil penalties, or criminal offences (sections 41MN and 41MNA of the Act).
The TGA will take regulatory action according to the Regulatory Compliance Framework.
Records management
To substantiate compliance with post-market responsibilities, medical device sponsors should keep records. This includes having procedures and records for:
- managing and reporting adverse events and other signals (complaints, incidents),
- processes to investigate the issues,
- investigation timelines, responsibility for actions, and
- recording the reasons for decisions.
The MDVP Pilot DTAs and inspections will involve reviewing procedures and records. It will also involve a review of systems and practices.