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ANALYSIS: Aus approvals could slide further with pre-market scrutiny hurdles

This article was originally published in Clinica

Executive Summary

The number of new medtech products on the Australian market has slowly declined over the six months to March 2013 and looks set to fall further if, as expected, tougher approval requirements are introduced for higher risk products.

Figure 1 shows that the number of new products registered on the Australian Register of Therapeutic Goods (ARTG) has fallen 21% over a six-month period, from 118 in October 2012 to 93 in March this year. While there was a spike in new entries between October and November last year (November recorded 158 new entries), the figure consistently declined thereafter.

All medical devices marketed in Australia must meet the requirements set out in Chapter 4 of the Therapeutic Goods Act 1989, and in the Therapeutic Goods (Medical Devices) Regulations 2002.

However, the Therapeutic Goods Administration (TGA) is also looking to beef up the approvals process, with the likely result a further slowdown in the number of approvals. Recent proposals (www.clinica.co.uk , 4 April 2013) from the regulatory body to increase its pre-market scrutiny of medical devices and improve transparency around its decision-making process drew concern from medtech companies that this could lead to delays in approvals and have a negative effect on the companies whose product approval refusals would be made public on the TGA's website. This is clearly a legitimate concern, given the number of approvals the small agency has to process and the fact that regulatory/quality professionals represent only 4% of personnel employed in the medtech sector, according to the Medical Technology Association of Australia (MTAA).

Currently, the TGA publishes limited information on devices included in the ARTG. The information can be viewed through the publicly accessible version of the ARTG and contains basic attributes such as the product's name on the label, identity and address of the device sponsor and manufacturer, the product's intended purpose etc.

The TGA's transparency proposal focuses on providing information about the degree to which a medical device has been assessed prior to inclusion in the ARTG. For example, this includes information on whether the medical device has been audited, the evidence considered in that audit and the extent to which TGA conformity assessments have been abridged. The proposal extends to publishing rejected and withdrawn applications, for which there is currently no visibility.

Fig 1. New ARTG entries from Oct 2012-March 2013-04-17



One thing adding to the complexity of the ARTG is the 2012 reclassification of hip, knee, and shoulder joint replacement implants from Class IIb (medium-high risk medical devices) to Class III (high risk medical devices). The reclassification initiative has a two year transition period, from 1 July 2012 to 30 June 2014. Musculoskeletal devices accounted for the second largest proportion of ARTG entries between October 2012 and March 2013 (see Figure 2)

Fig 2. ARTG entries by product type (Oct 2012-Mar 2013).



The change means that these devices will be added to the ARTG as "individual products", allowing for their better identification and traceability. Under the lower classification level, a number of such implants were included under a single ARTG entry.

The TGA estimates that from the third year of the implementation (ie 1 July 2014) there will be approximately 2,200 Class III hip, knee and shoulder implant entries in the ARTG.

In the six months to March 2013, there were 22 new hip systems, 56 knee systems and 10 shoulder systems approved. The full list is below.

New hip, knee and shoulder systems on ARTG (Oct 2012-March 2013)



Hip system 



Manufacturer 



MiniHip Stem -Prosthesis 



Corin 



Alloclassic Zweymüller Hip Stem  



Zimmer 



CLS Spotorno Hip Stem 



Zimmer 



Biolox Option Ball Head 



Medacta 



Biolox Option Sleeve 



Medacta 



Taper Alumina Ceramic Femoral Head 



Stryker 



V40 Taper BIOLOX Delta Ceramic Femoral 



Stryker 



RESTORATION ADM / MDM X3 Insert  



Stryker 



ABG II Alumina Ceramic Inserts 



Stryker 



Mectacer Biolox Delta Ceramic Liners 



Medacta 



Mectacer Biolox Delta Ball Head Taper 12/14 



Medacta 



ABG II Femoral Stem with HA 



Stryker 



ABG II Cup with HA for Ceramic 



Stryker 



EXETER V40 Femoral Stem 



Stryker 



ABG II Pack - Prosthesis 



Stryker 



ABG II Hooded Inserts 



Stryker 



RESTORATION ADM Cup with HA 



Stryker 



Contemporary Hooded Cup 



Stryker 



EXETER CONTEMPORARY Flanged Cup 



Stryker 



Targos Femoral Stems  



Life Healthcare 



Quadra-H Cementless 



Medacta 



Quadra-R Cementless 



Medacta 



Knee system 



Manufacturer 



Genesis II Cruciate Retaining Articular Insert 



Smith & Nephew Surgical 



Genesis II Dished Articular Insert 



Smith & Nephew Surgical 



Genesis II Constrained Articular Insert 



Smith & Nephew Surgical 



Oxford Medial Porous HA Coated Tibia with Extractor Slot 



Biomet 



Oxford Partial Knee System HiFlex Twin Peg Cemented Femoral 



Biomet 



Oxford Partial Knee System Femoral HA & Porous Coated 



Biomet 



Oxford Partial Knee Cemented Alpha Tibia 



Biomet 



Genesis II Nonporous Posterior Stabilised Femoral Component 



Smith & Nephew Surgical 



Journey Uni Tibial Insert 



Smith & Nephew Surgical 



Genesis II Oxinium Posterior Stabilised Femoral Component 



Smith & Nephew Surgical 



Journey Unicondylar Tibial Baseplate 



Smith & Nephew Surgical 



Genesis II Posterior Stabilised High Flexion Insert 



Smith & Nephew Surgical 



Genesis II Cruciate Retaining Deep Flexion Insert 



Smith & Nephew Surgical 



Genesis II Posterior Stabilised Articular Insert 



Smith & Nephew Surgical 



Genesis II Cruciate Retaining Femoral Component 



Smith & Nephew Surgical 



Genesis II Oxinium Cruciate Retaining Femoral Component 



Smith & Nephew Surgical 



Genesis II Non-Porous Tibial Base 



Smith & Nephew Surgical 



Oxford Partial Knee System Domed Lateral Bearing 



Biomet 



HLS Kneetec Mobile Tibial Tray 



Tornier 



HLS Kneetec Mobile Tibial Insert 



Tornier 



Bi-Cruciate Stabilised (BCS) Knee Femoral Oxininium Nonporous 



Smith & Nephew Surgical 



Oxford Partial Knee System Anatomic Meniscal Bearing 



Biomet 



HLS Kneetec PS Femoral Component 



Tornier 



TiNbN Coated Oxford Knee Femoral Component 



Biomet 



BalanSys TiNbN cemented PS femur 



Mathys Orthopaedics 



JOURNEY OXINIUM Unicondylar Femoral Implant 



Smith & Nephew Surgical 



Oxford Partial Knee System Domed Lateral Tibial Tray 



Biomet 



Oxford PKS Cemented Tibia TiNbN coated 



Biomet 



balanSys cemented femur 



Mathys Orthopaedics 



balanSys cemented PS femur 



Mathys Orthopaedics 



balanSys uncemented femur 



Mathys Orthopaedics 



Evolis Postero-Stabilized Insert + Screw 



Medacta 



Evolis uncemented tibial component 



Medacta 



Evolis Resurfacing Patella 



Medacta 



Evolis Ultra-Congruent Flex Insert 



Medacta 



Evolis Tibial Extension Stem 



Medacta 



Evolis Cemented PS Femur TiNbN Coated 



Medacta 



Evolis Cemented Postero-Stabilized Femur 



Medacta 



Evolis Cemented Standard Femur TiNbN coated 



Medacta 



Evolis Standard Insert 



Medacta 



Evolis Cementless Postero-Stabilized Femur 



Medacta 



Evolis Inset Patella 



Medacta 



Evolis Cemented Standard Femur 



Medacta 



Evolis cemented tibial component 



Medacta 



Evolis Cementless Standard Femur 



Medacta 



Coated knee femur prosthesis 



Oceania Orthopaedics 



Uncoated knee tibia 



Oceania Orthopaedics 



Knee prosthesis 



Oceania Orthopaedics 



Coated knee tibia prosthesis 



Oceania Orthopaedics 



Uncoated knee femur prosthesis 



Oceania Orthopaedics 



Knee stem 



Oceania Orthopaedics 



Shoulder system 



Manufacturer 



BIGLIANI/FLATOW Modular Humeral Stems 



Zimmer 



Equalis Keeled Spherical Base Glenoid 



Tornier 



Aequalis PerFORM Keeled Glenoid  



Tornier 



Aequalis PerFORM Pegged Glenoid 



Tornier 



Aequalis PerFORM Cortiloc Pegged Glenoid 



Tornier 



Aequalis Pegged Spherical Base Glenoid 



Tornier 



Aequalis Humeral Head - Ti6AI4V 



Tornier 



Aequalis Press-Fit Cementless Humeral Stem 



Tornier 



Sidus Stem-free Shoulder Humeral Head 



Zimmer 



ReUnion HA Fracture Humeral Stem 



Stryker Australia 

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