Postmarket activities
Australian medical devices guidelines
Guidance document number 11, Version 1.7
This guidance document is one of a series that has been produced to help explain the new regulatory system for medical devices in Australia that commenced on 4 October 2002. The new system has been established by the Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Medical Devices) Regulations 2002.
This guidance document describes the obligations and responsibilities of sponsors and manufacturers of medical devices after medical devices have been approved for supply in Australia.
Australian medical devices guidelines: 11. Postmarket activities (pdf,288kb)
Once a medical device has been approved for supply it is necessary to make sure that the product continues to meet all the regulatory, safety and performance requirements and standards that were required for the approval. This is in addition to ensuring that any problems with the product are dealt with and reported through appropriate channels. This postmarket phase for a medical device is as important as all of the pre-approval activities.
Manufacturers must hold and make available on request by the TGA, the technical documentation that demonstrates the conformity of their products with the essential principles and evidence that an appropriate conformity assessment procedure has been applied. Sponsors must have access to this evidence and be able to provide it on request.
There are three major components of postmarket activities. The sponsor of the medical device has a role to play in each of them. The components are:
- The manufacturer's post-market surveillance system,
- Post-market monitoring of market compliance by the TGA, and
- Vigilance programs.
Contents
- Introduction
- Medical device postmarket activities
- The manufacturer's post-market surveillance system
- Post market monitoring of market compliance by the TGA
- Vigilance Programs
- Australian sponsor's post-market responsibilities
- Adverse events
- Reporting
- Reportable events
- Reporting exemption rules
- Timeframes for submitting adverse event reports
- Details to be included in a report
- Annual reports of problems - Class III & Active Implantable Medical Devices
- Address for submission of adverse events and other reports
- Access to a device suspected to be involved in the event
- Vigilance exchange
- Enforcement
- Recalls of therapeutic goods
- Non-Recall actions for therapeutic goods
- Offences, penalties and cancellations
- Offences and penalties
- Other penalties
- Cancellations
- Distribution Records and other kinds of information
- Attachment 1 - Adverse Event Report Form
- Attachment 2 - Medical Device Incident Report Form