KD&A

The TGA have published a guidance document for manufacturers of in-house IVDs (in-vitro diagnostic device) to assist in ensuring compliance with the new regulatory framework, released on 1 July 2010. The guidance is easy to understand and is a must read for Australian in-house IVD manufacturers.

An in-house IVD is defined as the following in the Therapeutic Goods (Medical Devices) Regulations 2002 as amended, Regulation 1.3:

An in-house IVD device means an IVD medical device that is:

(a) Within the confines or scope of an Australian medical laboratory or Australian medical laboratory network:

i. Developed from first principles; or

ii. Developed or modified from a published source; or

iii. Used for a purpose, other than the intended purpose assigned by the manufacturer; and

(b) Not supplied outside that medical laboratory or medical laboratory network.

In-house IVDs are, in general, pathology tests that have been developed or modified by a medical laboratory to carry out testing on human samples, where the results are intended to assist in clinical diagnosis or in making decisions concerning clinical management. The regulations are not limited to NATA accredited medical testing laboratories but extend to all laboratories that manufacture in-house IVDs as prescribed in the regulations. There are three broad situations where, in accordance with Regulation 1.3, a laboratory is considered to have manufactured an in-house IVD.

In-house IVDs must be classified according to the classification rules given in the Therapeutic Goods (Medical Device) Regulations 2002 as amended. Based on the determined classification conformity assessment procedures shall then be followed.

All Class 4 in-house IVDs shall comply with the requirements defined for commercially supplied Class 4 IVDs.

The conformity assessment procedures for Class 1-3 IVDs are specified in Schedule 3, Part 6A of the Regulations. To meet the basic requirements, the following activities must be completed:

• Notify the TGA annually of the contact details of the laboratory and provide the name and risk class for each in-house IVD manufactured. This must be completed annually via the TGA’s online system, eBusiness.  Details will be recorded on the In-House IVD Notification Database.
• Meet the requirements defined in by the National Pathology Accreditation Advisory Council (NPAAC) performance standard.
• Obtain and maintain National Association of Testing Authorities (NATA) accreditation (or conformity assessment body accreditation (as deemed suitably by the TGA)).
• Meet the standard ISO 15189 Medical Laboratories – Particular Requirements for Quality and Competence.

The manufacturer (the laboratory) is required to hold information in relation to their quality management system, the design and manufacture of each in-house IVD and other documentation specified in the NPAAC standard. A post market system must also be implemented.

With a transition period that begun in 2010, in-house IVD manufacturers have until the 30 June 2014 to comply with the specified requirements. It is recommended manufacturers demonstrate compliance as soon as possible to avoid a long TGA review period.

The TGA Guidance can be found at http://www.tga.gov.au/pdf/ivd-regulatory-requirements.pdf.

For assistance completing regulatory activities for in-house IVDs, contact KD&A.

The Australian government released the Blueprint for TGA’s future in early December 2011 which describes the results of 18 months of discussion and review of proposed reforms. The reforms are designed to improve the transparency and efficiency of therapeutic goods regulation and will affect almost all manufacturers and sponsors of therapeutic goods in Australia.

The government’s blueprint includes the following:

• Plans to focus on improving communication and engagement with the community with the intention of becoming a well known and understood regulatory agency.
• Plans to establish an Australian Therapeutic Goods Advisory Council which will facilitate direct public feedback and comment on TGA activities
• An intention to improve current arrangements for the regulation of therapeutic goods advertising by creating a central point for all complaints about advertising, and the development of options for further consideration.
• A plan to update and include in the regulation of complementary medicines the ‘guidelines for the levels and kinds of evidence to support indications and claims’ to increase rate of compliance with regulatory and legislative requirements.
• Medical device reforms including increased rigour of pre-market regulatory assessment of high risk devices, reclassification of load bearing joint replacements (from Class IIb to Class III), a requirement that Australian Register for Therapeutic Goods (ARTG) inclusions to specify all devices sold under each ‘kind of medical device’ inclusions, and an increase in the product information available on the TGA website.
• A commitment to maintain an emphasis on self-regulation of industry in relation to promotion of therapeutic goods.
• An indication that a modest increase in fees will apply to implement the fundamental reforms.

Whilst reforms are welcomed, there appears to be some disappointment in the failure to implement reforms to create equality in the promotion of therapeutic goods. Based on the government’s current stance, a level playing field appears somewhat out of reach for industry. It has also been said that an increase in fees is likely to be not well received by sponsors and manufacturers in Australia, with current fees already considered to be significant for smaller companies.

For manufacturers and sponsors, the reality of the reforms is here, meaning it is time to prepare your organisation to comply with the requirements or implement plans to do so. For medical device reforms, transition periods apply however it is recommended that a focus on compliance within your organisation is actioned as soon as possible.

To better understand new requirements for your organisation and for guidance regarding the most effective way to comply,  contact KD&A.

The TGA proposed regulatory reforms during October 2010 in response to the Australian Government Health Technology Assessment Review (HTA) and after considerable consultation further information has been released. The announced reforms will have an effect on almost all medical device manufacturers and sponsors placing medical devices on the market in Australia. Read on to see how the reforms affect you. (more…)

Positive news for therapeutic goods manufacturers as the Australian and New Zealand Governments agree to resume plans for a joint scheme for regulation of therapeutic goods. The joint scheme will reduce regulatory burden for industry in both Australia and New Zealand. (more…)

The internet is a vast resource and hunting through available information can be time consuming  – making it difficult for you to find what you need, when you need it. As an Australian medical device or IVD manufacturer or sponsor there are some key websites which allow you to have valuable and reliable information at your fingertips.  The sites below are worth adding to your favourites list.

• The Therapeutic Goods Administration website acts as an excellent resource, providing information such as the Australian Regulatory Guidelines for Medical Devices and IVD guidance documents.

• The Australian ComLaw website provides access to full copies of the Therapeutic Goods (Medical Device) Regulations 2002 as amended along with other Acts and Regulations. (more…)

The 4 Corners program on ABC television which aired on the 16th of May explored the failure and subsequent recall of the DePuy Orthopaedics ASR hip replacement device, raising questions regarding the regulation of joint implants in Australia. (more…)