2012 February

In-house IVDs – TGA Release New Guidance

February 23, 2012 | by Philippa Moore

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.

This article appears in the categories Medical Technology Regulation News TGA

What Does Recall Really Mean? The GHTF Aim to Provide Clarity

February 16, 2012 | by Philippa Moore

The recent PIP breast implant saga is a reminder of just how important it is for us, the medical device industry, to have a universal system for identifying, classifying and resolving product recall situations. Despite its importance, the term recall is currently not harmonised. The term has different meanings depending on region which can result in confusion for regulatory authorities and users worldwide. The Global Harmonisation Task Force (GHTF) has released a draft guidance document which may just pave the way for harmonised terminology, clarifying things for all medical device manufacturers.

The guidance document defines Field Corrective Actions (FCAs) which include Field Safety Corrective Actions and Non Safety related Field Corrective Actions. The actions are classified based on the type and extent of the corrective action and importantly, the level of risk posed to patients, users or others affected by the device’s use. The classification system provides a mechanism for manufacturers to develop comprehensive strategies including planning for communication, action and follow up and for regulatory authorities to monitor progress of the FCA.

The guidance document provides practical examples of each type of FSCA (of which there are 5) and Non Safety related Field Corrective Actions (of which there are 3). These are given below.

Safety Related Field Corrective Actions (e.g. FSCA):

Device Removal (Device Recall)
Device Modification
Implant Alert
Device Precaution
User Warning

Non Safety related Field Corrective Actions:

Device Withdrawal
Device Enhancement
Stock Recovery

The classification system requires manufacturers to propose an expected level of risk to patients, users and others if use of the device was to continue. Classification of FCAs is divided into 3 levels, these are given below:

FCA Class I: Taken by a manufacturer when death or serious deterioration in the state of health of a patient, user or other person has occurred, or there is a reasonable probability that exposure to or use of the device can lead to death or a serious deterioration of health.
FCA Class 2: Taken by a manufacturer when there is a reasonable probability that the exposure of use of the medical device has or can lead to temporary illness, injury, mistreatment or deterioration of the state of health of a patient, user or another person
FCA Class 3: Taken by a manufacturer when there is a reasonable probability that the exposure or use of the device will not lead to temporary illness, injury, mistreatment or deterioration in the state of health of a patient, user or other person.

Whilst still in draft form, the document does provide useful guidance and is a must read for all medical device manufacturers. Find it here.

KD&A can assist your organisation to develop suitable post market procedures to ensure you are prepared and can comply with the regulatory requirements in the markets into which you sell your devices. Visit the Post Market Surveillance System page or contact KD&A.

This article appears in the categories Medical Technology Regulation News

Export Corporation Penalised $3.1 Million for Illegal Supply

February 14, 2012 | by Philippa Moore

On the 3rd of February 2012 the Federal Court ruled that Export Corporation (Australia) Pty Ltd should pay civil penalties of just over $3.1 million for importing and supplying a number of products that were not on the Australian Register for Therapeutic Goods (ARTG). This comes as stern reminder for all therapeutic goods manufacturers and suppliers that regulatory requirements should be a key component of business practice in Australia.

The decision shows that the Federal Court can and will impose significant penalties on therapeutic goods manufacturers and suppliers who import or supply therapeutic goods without completing the required regulatory actions.

The TGA report that in the period from 2006 to 2009 Export Corporation imported and supplied over 35 products that were not certified by the TGA as required. These included nutritional and weight loss products as well as body building, muscle growth and vitamin products.

In deciding the applicable penalty, the Federal Court took into account the following:

The large number of contraventions (numbering in the thousands)
The lack of appreciation by the company of the seriousness of the regulatory requirements
The deficiencies in the company’s compliance culture
The need for the level of penalty to act as a deterrent to others who might be tempted to “make the same mistake” and to serve as a particular message to those involved in importing and distributing sports supplements in Australia

The best advice we can give is if you are unsure of regulatory requirements applicable to your organisation, don’t risk it. Contact KD&A for guidance and assistance.

This article appears in the categories News TGA

Changes Afoot for Medical Device Manufacturers in Argentina, Brazil, Colombia and Cuba

February 1, 2012 | by Philippa Moore

The agencies which regulate medical devices in Argentina, Brazil, Colombia and Cuba have initiated plans to work together to recognise certification of medical device manufacturers. The regulatory bodies ANMAT (Argentina), ANVISA (Brazil), INVIMA (Colombia) and CECMED (Cuba) have recently signed an agreement as a result of an initiative which was passed during the Pan-American Health Organisation (PAHO/OPS) September/October 2010 summit.

The details of the mutual agreement are to be defined during 2012 and it is hoped that the agreement will be operative from 2013. The four regulatory bodies will work independently to begin with to certify manufacturers as compliant with mutually recognised good manufacturing practice (GMP) standards. This model will then adapt to allow for joint inspections to the GMP standards. Down the track it is planned that other activities (including product recall) will be completed on a mutual basis.

The mutual agreement will mean reduced regulatory burden for medical device manufacturers in these regions, and may eventually broaden to bring benefit to overseas manufacturers also. As with many other regions worldwide, a mutually governed approach to medical devices is developing.

For assistance obtaining regulatory certification outside of Australia, please contact KD&A.

This article appears in the categories Medical Technology Regulation News