On 5^th November 2008 TGA will launch the much anticipated, and needed, revision to its online SIME system. The new Electronic Business Services (eBS) is a complete redesign of the existing system and will provide a single portal for all electronic facilities with the TGA in medical device and medicines applications, manufacturers evidence, access to the ARTG and administrative details. The changes are both cosmetic and functional.

Immediate approval for Class I devices

The most hotly anticipated change will be the automatic inclusion of Class I (non-sterile, non-measuring) on to the ARTG. This move will align practices with the original intent of the legislation and bring Australian practices closer to those seen in Europe and America for many years. From the 5^th of November TGA intends all Class I devices will be included on the ARTG within 24 hours of submitting the application online.

This new approach to Class I devices is a welcome improvement on current practices which saw lengthy increases in time-to-market for many companies.

The change will include a revised list of questions in the online application form to provide greater validation that the device meets the classifications requirements for the Class I device. There will also be greater checks on the Intended Purpose, including a list of Restricted and Prohibited words for Class I applications. Use of these words within the Intended Purpose will either flag the application or prevent its submission. TGA has published a first draft of the "Prohibited/Restricted Word List". The list clearly aims to capture things like biological products, implants, diagnostics and devices which include medicines. However it's potentially a fairly blunt instrument. For example applications containing the words caliper, trial, and prosthesis are widely used to describe a range of genuinely class I devices. TGA has given assurances that the word check will be a brief review only so should not unduly delay legitimate Class I applications.

Class I devices will be controlled through a greater emphasis on postmarket monitoring, a growing world-wide regulatory trend. There will be three levels of postmarket reviews; Targeted Level 1, Targeted Level 2 and Random. Use of a restricted word in the intended purpose will automatically result in a Level 1 review. This review will examine the appropriateness of the classification, GMDN code and Intended Purpose, it will not review the technical file. Targeted Level 2 reviews will be conducted due to a number of reasons including among others; outcomes of Level 1 reviews, trends in IRIS reports, repeated breaches of the advertising code and recalls. Finally, random Level 1 and Level 2 reviews will be conducted.

Worth Waiting...?

For those with applications currently in draft it must be noted that on the 29^th October all Class I applications in draft will be deleted by the TGA. All other applications will be retained; however you may be required to complete additional fields to validate the submission. Any application that has already been lodged with the TGA will continue to be processed in the old system. If you are close to submitting a Class I application, it may be worthwhile holding off until after the 5^th November.

More detailed information is available at TGAs eBS help page.

Manufacturer's Evidence

Another welcome change in the works at TGA is the automation of new or revised manufacturers' evidence and the introduction of a combined device application and conformity assessment process. This new process is currently slated to be implemented in May 2009. Currently the two processes run in series, with lengthy queuing delays.

Currently the rejection rate of manufacturers' evidence is approximately 45%, the TGA wishes to reduce this to 10% before implementing the combined assessment process. The TGA will undergo a sponsor teaching process in an attempt to reduce this rejection rate. The high rejection rate is primarily due to sponsors not providing all the necessary documents. The training process will aim to teach sponsors to thoroughly check their applications prior to submitting evidence. For more guidance on the TGA's requirements for manufacturers evidence consult TGA Guidance Document 20 Obligations and responsibilities of medical device sponsors and manufacturers and TGA Devices Fact Sheet 17 Manufacturers' evidence - EC certificates for medical devices