TGA changes for Medical Devices in Australia

BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com

The Big Changes in Australia in Medical Devices

Product Development and Market Access Down Under

Dr Arthur Brandwood • Previous Director Devices Registration and Assessment at TGA and

Director, TGA Biomaterials and Engineering Laboratories

• Past National Chair and Chair Regulatory Expert Panel AusMedtech

• Member of AHWP SG1 and Leader of Combination Products Task group

• Adviser and trainer to multiple Asia Pacific regional regulators

• Australian Delegation Leader to ISO TC 194 – Biocompatibility and Clinical Trials and ISO TC 150 – Implantable Devices

• Past President Australian Society for Biomaterials

• Visiting Professor in Biomedical Engineering, University of Sydney


BRANDWOOD:BIOMEDICAL securing your compliance

Medical Devices and IVDs

Asia Pacific Focus

Global Perspective

Highly Networked

Highly Engaged


http://asiapacificdevicesummit.com/



Why Australia?

Deregulation

Clinical Trials

R&D Tax Concessions

Employee Options Tax Concessions

Trade with Asia



The Single Largest Manufacturing Sector Exporting

from Australia to China is Therapeutics (Medical Devices

and Pharmaceuticals) Australian Bureau of Statistics


Health Spending - Australia


Limited Resources: <100 in Devices

Acts as both Competent Authority

and Conformity Assessment Body

Strong scientific culture – this was once a

laboratory building!


Therapeutic Goods Act 1989 http://www.tga.gov.au/industry/legislation.htm

Chapter 1—Preliminary

Chapter 2—Australian Register of Therapeutic Goods

Chapter 3—Medicines and other therapeutic goods that are not medical devices

Part 3-1—Standards

Part 3-2—Registration and listing of therapeutic goods

Part 3-3—Manufacturing of therapeutic goods

Chapter 4—Medical devices

Part 4-1—Introduction

Part 4-2—Essential principles and medical device standards

Part 4-3—Conformity assessment procedures

Part 4-4—Conformity assessment certificates

Part 4-5—Including medical devices in the Register

Part 4-6—Suspension and cancellation from the Register

Part 4-7—Exempting medical devices from inclusion in the Register

Part 4-8—Obtaining information

Part 4-9—Public notification and recovery of medical devices

Part 4-10—Assessment fees

Part 4-11—Offences and civil penalty provisions relating to medical devices

Chapter 5—Advertising, counterfeit therapeutic goods and product tampering


Therapeutic Goods (Medical Devices) Regulations 2002

Includes AIMDs and

IVDs

5.7 Active implantable medical devices

(1) An active implantable medical device is classified as Class AIMD.

Four New Rules for IVDs


Special Access

Clinical Trials

Authorised Prescriber

Custom Made

CTN

CTX

SAS B

SAS A

ARTG Inclusion

Exempt Goods

Personal Imports

AIMD Act Implant

III

IIb

I

NO TGA assessment of safety MUST MEET safety and performance

requirements

Generally humanitarian exemptions or advance

access to new technology

pending completion of

TGA regulatory assessment

For Investigational use only – for research or to gather clinical

data to support subsequent

TGA assessment

This is a unique

Australian regulatory

peculiarity – a person

may import any device or

medicine (except S8

poisons e.g. narcotics) for personal use at own risk

These are single devices individually

manufactured to clinical

prescription for a named

patient (e.g. dental crowns,

orthotic braces)

These are very low risk goods (e.g.

hospital bedding, protective clothing,

conventional toothpastes)

These devices and IVDs are subject to

TGA regulatory assessment which

increases with higher numbered

risk class

These devices are NOT assessed by TGA and are EXEMPT from inclusion on ARTG – but they must still

meet safety and performance regulations and are subject to

postmarket monitoring

IIa

IVD 4

IVD 3

IVD 2

IVD 1

Australian Regulatory Requirements


Sponsor – the Australian Authorized Representative

Must be Australian company

May be third party

Provides manufacturer info to TGA on demand

•Contractual arrangement with manufacturer

BRANDWOOD

BIOMEDICAL securing your compliance



TGA accepts CE certificates

in lieu of Australian Certificates

for most devices


Fast Track

Have Your Certificates Ready


TGA Sponsor Manufacturer

Determine AU Class

Technical File Data

Australian D.o.C

CE Certification

Accepted Manufacturer

Evidence

Sponsor Makes ARTG

Application for Device

Sponsor Submits To TGA

Assess e

Assess ARTG Entry e Application

Audit


Exclusions to the CE Fast Track

Class III with integral medicine

•Also requires TGA medicine assessment

Class III with biological component

•Includes recombinant products, blood products

•Some low risk exceptions e.g. gelatine

All Australian manufactured devices

•Direct TGA assessment is mandatory for the locals

•TGA may abridge assessment if device is CE marked



“As an important first

step, the Government

will enable Australian

manufacturers of

medical devices the

option of using

European Union

certification in place of

TGA certification. This

will place Australian

manufacturers on the

same footing as

overseas

competitors.”


Exclusions to the CE Fast Track

Class III with integral medicine

• Also requires TGA medicine assessment

Class III with biological component

• Includes recombinant products, blood products

• Some low risk exceptions e.g. gelatine



Multiple Reviews of TGA

3 Senate enquiries

Auditor General Review

HTA Review

…

TGA


It’s all about Confidence…

TGA is undertaking Confidence Building with EC Notified Bodies

−Shared Audits

−Document reviews

−Information Exchange

Reduced Application audits for those in which TGA has Confidence


Special Access

Clinical Trials

Authorised Prescriber

Custom Made

CTN

CTX

SAS B

SAS A

ARTG Inclusion

Exempt Goods

Personal Imports

AIMD Act Implant

III

IIb

I

NO TGA assessment of safety MUST MEET safety and performance

requirements

Generally humanitarian exemptions or advance

access to new technology

pending completion of

TGA regulatory assessment

For Investigational use only – for research or to gather clinical

data to support subsequent

TGA assessment

This is a unique

Australian regulatory

peculiarity – a person

may import any device or

medicine (except S8

poisons e.g. narcotics) for personal use at own risk

These are single devices individually

manufactured to clinical

prescription for a named

patient (e.g. dental crowns,

orthotic braces)

These are very low risk goods (e.g.

hospital bedding, protective clothing,

conventional toothpastes)

These devices and IVDs are subject to

TGA regulatory assessment which

increases with higher numbered

risk class

These devices are NOT assessed by TGA and are EXEMPT from inclusion on ARTG – but they must still

meet safety and performance regulations and are subject to

postmarket monitoring

IIa

IVD 4

IVD 3

IVD 2

IVD 1

Australian Regulatory Requirements

Clinical Trial Notification

• Ethics Committee assessment of the protocol and oversight of trial

• TGA may audit the trial

• Nominal Fees

• Notification only to TGA

• All devices have been done this way to date


National Controls

http://www.australianclinicaltrials.gov.au/node/30


Lower Costs



“…it's CASH, paid quarterly, not a tax credit”

“Note the difference between the rebate and the tax rate - effectively the rebate is a subsidy way higher than the tax deductibility of these expenses”


Free Money – from the Tax Man The Australian R&D Tax Incentive

45% Refundable Offset

−Non refundable for firms >$20M turnover

−For small firms – paid as refund, quarterly

Eligible Entities

−Australian companies

−Foreign companies in countries with double tax agreement which have permanent establishment in Australia

https://www.ato.gov.au/Business/Research-and-development-tax-incentive/











35


The R&D challenge…

Clinical Challenge

• Bowel Preps available in Australia not effective

• Require significant investment to develop data

• High patient population requires significant sample size

Clinical Trial Required

• Multicentre

• Randomised

• CRA Audited

• 300 Patients

• $ 1 Million budget

ANZ operations didn’t have budget to support


R&D Tax Incentive

Given ANZ subsidiary, local profits 3-4%

Provided potential for legitimate cost savings and capability

Needed to demonstrate that proposed trial outcomes had not already been demonstrated ie: True R&D


Employee Share Options

July 2015 commencement

Defer tax until exercise of options

Maximum time for deferral 15 years

Standardised documentation for establishment and maintenance of ESS.


Start-up Concession for ESS

Unlisted Co. / Aggregate Turnover <$50M / Inc. < 10 Years

Tax exempt first $1,000 for employees earning <$180,000

Shares at discount of up to 15% with no tax liability for discount

−Discounted portion is exempt from CGT at time of sale

Shares must be held at least 3 years


Why Australia?

Deregulation

Clinical Trials

R&D Tax Concessions

Employee Options Tax Concessions

Trade with Asia



Regulatory Trends in Asia Pacific

2015 ASEAN MDD Commences

2014 ASEAN harmonizes IVD registration format New Provisions in China Japan PMDL Malaysia Regulations

2013 China SFDA becomes CFDA

2011 India Medical Devices

2010 HK Medical Devices Registrations

2009 Korea High-risk IVD Tougher regs

2008 HK IVD Voluntary Product Listing Singapore Mandatory Registration

2007 Major Regulation Change in China

2006 Malaysia Voluntary Product Listing

2005 Japan PAL

2004 Hong Kong Medical Device Registration –excludes IVDs Singapore Voluntary Listing

2002 China Mandatory Product Registration





Let’s talk!

TGA Submissions

Australian Sponsor Service − and others including China

Regulatory Strategy

Risk Analysis and Standards Compliance

Quality Systems

Clinical Trials

Postmarket Compliance

Reimbursement

Regulatory Intelligence

Training

Contact us for a free no-obligation consultation and

quote

+61 2 9906 2984

[email protected]

www.brandwoodbiomedical.com

Brandwood Biomedical has offices in Sydney, Wellington and Beijing and offers specialist expertise throughout the

Asia Pacific

http://www.brandwoodbiomedical.com/

Date post:	04-Jul-2015
Category:	Healthcare
Upload:	joe-hage
View:	613 times
Download:	1 times

TGA changes for Medical Devices in Australia

Healthcare