Australia’s TGA Releases New Guidance on Conformity Assessment Procedures
Australia’s Therapeutic Goods Administration released new draft guidance spelling out what steps are needed when devicemakers that have been issued conformity assessment certificates in Australia and want to make a change.
The guidance includes events that trigger a transfer of a conformity assessment certificate and associated manufacturer responsibilities. It is one of three the TGA will release related to new conformity assessment procedures in the Australian Regulatory Guidelines for Medical Devices (ARGMD). Australia’s device regulations are undergoing a major update, and more guidance will be issued on a range of other issues including notified bodies in Australia, accelerated reviews for devices and other procedural changes.
For any device changes, manufacturer s are expected to have written procedures in their quality management systems that cover change management and guides to decision making. They must consider the impact of any changes on regulatory requirements and risk management and must document the risks and decisions.
Critical changes would include a change in a sterilization method or manufacturing process, a change in the location of a key step in manufacturing such as outsourcing. Other changes that require notification include changes to the product range, changes to product design, changes to labeling and instructions for use.
Changes that are not considered substantial would include:
- Changes to non-critical parts or suppliers that still meet the acceptance criteria established by the manufacturer;
- Changes to manufacturing equipment or processes that are not likely to influence the level of risk; and
- Changes to the packaging or labeling that do not alter compliance.
Companies must notify the TGA of any substantial change before supplying affected products affect. When a conformity assessment certificate will be transferred, the TGA should be notified
within three months. Events that trigger a transfer would include bankruptcy, a name change, disposal of the business or amalgamation with another company.
The TGA will soon release a new online conformity assessment application form and will launch a new certificate repository that will automatically generate conformity assessment certificates when an assessment is concluded.
Included in the TGA guidance is a checklist for devicemakers that covers essential principles for medical devices. The 20-page checklist is comprised of 15 sections, including: design and construction and intended use; safety and adverse events; verification and validation and risk control elements related to substances used in manufacturing; infection and microbial contamination; protection against radiation; implantable devices and IVDs.
The regulator also noted that annual fees will now apply to IVDs, and companies will be charged AUS$660 (U.S. $500) for each entry for the 2017 to 2018 financial year.