Medical Devices Vigilance Program pilot

The Medical Devices Vigilance Program (MDVP) pilot ran for 12 months.

It aimed to support Australian medical device sponsors comply with their ongoing post-market surveillance responsibilities under:

• the Therapeutics Goods Act 1989 (the Act) and
• the Therapeutic Goods (Medical Devices) Regulations 2002.

The pilot was designed to complement our post-market surveillance of medical devices, including

• post-market reviews,
• adverse event monitoring, and
• audits of medical device manufacturer facilities.

Participants

The pilot was open to all ARTG-registered Australian medical device sponsors. Participation was voluntary.

Sponsors had the opportunity to work with us to learn more about their post-market regulatory requirements. This included understanding whether their processes or procedures are sufficient to ensure compliance with the legislative requirements.

MDVP pilot process

We held a sponsor Information Session (webinar) in September 2023. Sponsors learnt about the MDVP pilot, its processes and what to expect during the program.

Self-Assessment Tool (SAT)

Sponsors were invited to complete and submit a Sponsor Vigilance Self-Assessment Tool (SAT).

The SAT is a set of questions that helped sponsors to better understand their post-market regulatory obligations.  The tool also, helped us to select sponsors for desktop audits and/or on-site inspections, as well as support regulatory education.

Desktop audit (DTA)

A range of sponsor types were selected. For example, sponsors with different sized Australian Register of Therapeutic Goods (ARTG) portfolios or sponsors with devices over a range of classifications.

Selected sponsors were provided with a request for information through section 41JA of the Therapeutic Goods Act 1989 (the Act).

Following review, sponsors received DTA outcome letters summarising:

• what we requested and reviewed,
• whether they would progress to an on-site inspection, and
• educational information to help improve understanding of the relevant post-market regulatory obligations.

On-site inspection

Inspections of sponsor sites were conducted over one day. The inspections aimed to review sponsor’s post-market surveillance systems, processes, and procedures.

During the inspection, TGA inspectors:

• reviewed how sponsors receive, respond, record and report device events or incidents (including complaints, adverse events, and recall or non-recall actions),
• interviewed staff in the organisation,
• examined the facilities, and
• discussed observations and preliminary findings at the closing meeting.

After the inspection, a sponsor inspection report was provided. It summarised TGA feedback.

In some cases, sponsors had to:

• establish a corrective action plan and
• provide a response on any corrective actions taken to address feedback.

Powers to request information and inspect premises

The MDVP pilot utilised powers listed in the Act.

Under section 41JA of the Act, we requested information from sponsors and set response deadlines. This was 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.

Next steps

We are currently reviewing feedback from participating sponsors. An evaluation is in progress, and its outcomes will help to inform the next steps.

Contact us

If you have any questions or would like to participate, contact us at: MDVP@health.gov.au