TGA Reclassification Deadline Drawing Closer

The TGA announced the reclassification of hip, knee and shoulder joint implants (total and partial) in 2012. The announcement required medical device manufacturers and sponsors to update their product certification and Australian Register for Therapeutic Goods (ARTG) inclusion – transitioning from a Class IIa/IIb to a Class III.  A transition period was granted however this is due to conclude on the 30th June 2014.

As described in our news story dated September 2012, reclassification applies to a number of products. The GMDN codes associated with affected devices on the Australian Register for Therapeutic Goods (ARTG) can be found on the TGA website. After 30th June 2014, sponsors of all Class IIb hip, knee and shoulder joint implants need to have submitted a reclassification application to transition the product.

The TGA are urging sponsor and manufacturers to move quickly to avoid cancellation – which will occur on the 1st July 2014 for any outstanding ARTG inclusions.

KD&A can assist your organisation to complete the transition smoothly and efficiently. Do not hesitate to contact with any questions, or if you would like a quotation for our services.