Regulatory News

The International Medical Device Regulators Forum (IMDRF) Meeting Update

The successor to the now defunct GHTF, the International Medical Device Regulators Forum (IMDRF), has had its inaugural meeting in Singapore on 28 February to 1 March 2012. The IMDRF Management Committee will meet bi-annually. IMDRF meetings include an open session to which all interested stakeholders, such as industry, academia, health care professionals, and consumer and patient groups, are welcome.

Work items for progression:
1. review of National Competent Authority Report (NCAR) system
2. roadmap for implementation of Unique Device Identification (UDI) system
3. medical device single audit program (MDSAP)
4. recognised standards
5. regulated product submissions

The next IMDRF Meeting will be held in Sydney, Australia, on 25 to 27 September 2012. The Open Stakeholder Session will take place on Wednesday 26 September 2012.

Link to IMDRF website: http://www.imdrf.org/

 

Australian and New Zealand Medical Regulators to form joint trans-Tasman Scheme

On 28 January 2012, the TGA has released a statement regarding the revival of the Australia New Zealand Therapeutic Products Agency (ANZTPA). Agreement for a joint trans-Tasman regulatory scheme was first reached in 2003. However, the joint scheme did not proceed as New Zealand was unable to pass enabling legislation and subsequently negotiations were suspended in 2007. Last year both countries began to share resources, expertise and information. The transition will be implemented in three stages: 1) work sharing and increased operations; 2) establishing a single point of entry for industry and a common trans-Tasman regulatory framework; 3) establishing of a single regulatory body.

According to the TGA statement, "over a period of five years the new regulatory Agency will replace Australia's Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) with the objective of ensuring that consumers have access to safe, quality medicines and medical devices which are brought to market through a single approval process for both countries".

The TGA press release:

http://www.tga.gov.au/about/international-anztpa-imc-120128.htm

 

Latest changes to ACMA’s Telecommunications Labelling Notice (TLN)

On 4 May 2011, the Australian Communications and Media Authority (ACMA) issued a new version of the Telecommunications Labelling (TLN) Notice 2001 (Customer Equipment and Customer Cabling).

The 2011 version of the TLN describes mandatory A-tick requirements for telecom devices. These are listed in Schedule 1, Part 2 and include a new category of equipment, A55: Mobile Equipment, which includes IMT-2000 devices.

This new category covers mobile devices such as telephone handsets, tablet PC’s and modems which support UTRA FDD (WCDMA) bands, E-UTRA FDD (LTE) bands and OFDMA TDD WMAN bands.

A new technical standard AS/CA S042.4: 2010 was released to cover the IMT-2000 technology.

At the same time, Division 4.5 of TLN was changed and now IMT-2000 devices will not be required to obtain a written carrier’s permission.

Currently and until 30 April 2012, it is still acceptable to receive the carrier’s permission instead of showing compliance to the AS/CA S042.4 standard.

Certification Body Australia (CBA) provides certification of GSM products against the standards AS/ACIF S042.1 and AS/ACIF S042.3. In addition to these standards, CBA is accredited by the ACMA to provide assessment of documents related to AS/CA S042.4 requirements and issue compliance reports. These reports can then be used as an alternative to receiving the carrier’s permission.