TGA News Issue 56 (July 2008) - Medical devices
ADN form
A new form Australian device name (ADN) nomination form is now available <http://www.tga.gov.au/devices/forms/formadn.htm>. This form should be used when proposing a name for a new ingredient used in a formulated medical device.
ARGMD
The TGA is developing a consolidated reference document detailing the Australian regulatory requirements for medical devices.
The Australian Regulatory Guidelines for Medical Devices (ARGMD) will provide guidance on all the regulatory requirements for medical devices in Australia and will be made available on the TGA website. It will replace the existing guidance documents and information sheets for medical devices.
As each section is prepared, it will be released for comment, with a four week deadline. We welcome comments on the technical aspects of the document. We are keen to have stakeholder involvement in the development of the ARGMD as we want to ensure that the language is easy to understand.
Since the last issue of TGA News, a draft Table of Contents for the ARGMD has been made available. This shows the structure that is planned for the ARGMD, however please be aware that it will be frequently updated as the need for new information is identified.
The draft section on Fees & charges is available for comment with a closing date of 30 July 2008 <http://www.tga.gov.au/devices/argmd.htm>.
Clinical evidence for medical devices
Clinical data may be:
- clinical investigation data
- data from all formal clinical trials carried out using devices
- any other experimental use in humans using prototype devices or components for the purpose of developing or investigating their safety and performance
- data from clinical experience, including:
- manufacturer-generated post market surveillance reports, registries or cohort studies
- adverse events databases
- data for the device in question generated from individual patients under Authorised Prescriber and/or Special Access Schemes prior to marketing of the device
- details of clinically relevant fi eld corrective actions (eg recalls, notifi cations, hazard alerts)
- data, both favourable and unfavourable, obtained from a review of the literature:
- specifically about the device in question - where available, this must always be included in any review, and/or
- for comparative and well-established devices this must include relevant post market information
- if clinical data is not available adequate justifi cation should be provided to explain how data for a similar device can establish the safety and performance of the device in question.
Clinical data that is not acceptable includes but is not limited to: brochures, testimonials and product description.
Manufacturers must:
- demonstrate compliance with Essential Principle 14 relating to clinical evidence
- compile clinical data
- arrange for a signed and dated clinical evaluation report to be prepared by an expert.
The TGA will:
- ensure compliance with the relevant legislation, including Essential Principle 14
- assess the clinical evaluation report against the clinical data if and when requested from the manufacturer.
The TGA may seek the advice of the Medical Device Evaluation Committee to provide expert advice in relation to the medical device and the documented:
- performance
- safety
- benefit/risk assessment
- compliance with the TGA legislative requirements.
For more information, please see the guidance document Clinical evidence requirements for inclusion of medical devices in the ARTG <http://www.tga.gov.au/docs/html/devguid4.htm>.
MDEC
A summary of key resolutions and a meeting report from the Medical Device Evaluation Committee's June 2008 meeting are available <http://www.tga.gov.au/docs/html/mdec/mdecrecords.htm>.
Standards orders
New MDSOs
Two new medical devices standards orders have been finalised and the updated versions were registered on the Federal Register of Legislative Instruments (FRLI) on 28 May 2008. Both are available on the ComLaw website >http://www.comlaw.gov.au> and the TGA website:
- Medical Device Standards Order (Standards for Clinical Evidence) 2008
<http://www.tga.gov.au/legis/mdsoce2008.htm>
This Order specifies medical device standards relevant to medical devices that require clinical evidence in order to demonstrate compliance with the essential principles.
This Order is for all medical devices for which clinical evidence is required to demonstrate compliance to the essential principles. - Medical Device Standards Order (Standards for Risk Management) 2008
<http://www.tga.gov.au/legis/mdsorm2008.htm>
This Order specifies relevant medical device standards for the risk analysis and risk management methods concerning medical devices.
This Order determines medical device standards, which set methods for risk analysis and risk management in order to demonstrate compliance of medical devices with the essential principles.
Draft CASO & MDSO
The TGA is seeking comments on a proposal to adopt the following four standards orders.
- Conformity Assessment Standards Order (Standards for Quality Management Systems and Quality Assurance Techniques) 2008
- Medical Device Standards Order (Standards for Medical Devices Required to be Sterile) 2008
- Medical Device Standards Order (Standards for Natural Latex Rubber Condoms) 2008
- Medical Device Standards Order (Standards for Biological Safety and Biocompatibility of Medical Devices) 2008
This consultation closes on 15 August 2008. More information and copies of the draft orders: Stakeholder consultation: Medical Device Standards Orders (MDSOs) and Conformity Assessment Standards Orders (CASOs) <http://www.tga.gov.au/devices/drmdsocaso2.htm>.