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News Bulletin : ADA News Bulletin October 2011
12 OCTOBER 2011 committee report THE ESSEnTIAL PRInCIPLES For a medical device to be supplied in Australia, it must be demonstrated that the relevant Essential Principles have been met. The regulatory framework provides flexibility for manufacturers and caters for technological advances and changes in the development of new medical devices by not dictating how a manufacturer must prove that the Essential Principles have been met. The most common way to demonstrate compliance with the Essential Principles is to meet a standard published by an Australian or international standards agency, or a similar standard. If the manufacturer chooses to use other voluntary standards, they must provide evidence that the chosen standard is applicable to the manufacturer’s quality system and that its application satisfies the requirements of the Therapeutic Goods Act (Cth) 1989 and subordinate regulations. There are six general Essential Principles that apply to all devices. There are a further eight Essential Principles about design and construction that apply to devices on a case-by-case basis. GEnERAL PRInCIPALS fOR MEdICAL dEvICES: • medical devices not to compromise health and safety; • design and construction of medical devices to conform to safety principles; • medical devices to be suitable for intended purpose; • long-term safety; • medical devices not to be adversely affected by transport or storage; and • benefits of medical devices to outweigh any side effects. dESIGn And COnSTRUCTIOn PRInCIPLES fOR MEdICAL dEvICES: • chemical, physical and biological properties; • infection and microbial contamination; • construction and environmental properties; • medical devices with a measuring function; • protection against radiation; • medical devices connected to or equipped with an energy source; • information to be provided with medical devices; and • clinical evidence. Once a design specification that minimises the identified risks has been defined, the manufacturer will need to decide how to demonstrate that it meets the relevant Essential Principles. In many instances this will be achieved through implementation, maintenance and regular inspection of a quality management system by the device manufacturer. Importers must ensure that the medical devices they import comply with the Essential Principles and they have available sufficient information to substantiate compliance with the Essential Principles or have procedures in place, including a written agreement, to ensure such information can be obtained from the manufacturer within 20 working days. The TGA may request this information at any time. REGULATORY COMPLIAnCE The legal framework established by the Therapeutic Goods Act (Cth) 1989 requires that each manufacturer and importer be responsible for ensuring the medical device complies with the requirements of the legislation and is supplied in the same fashion. Manufacturers may act as a ‘sponsor’ but there is no requirement to do so. Sponsors supply the products to the Australian market place and are also responsible for ensuring that the product appears on the ARTG. dISTRIbUTIOn RECORdS Under the Therapeutic Goods Act (Cth) 1989 the sponsors of medical devices supplied in and exported from Australia are required to keep distribution records of the medical devices. This is required to expedite any recalls of batches of the medical devices and identify the manufacturer of each batch of devices. Importers are not required to maintain records of the individual users of medical devices. However, the importer should have records of distribution centres, hospitals and export countries to which the device has been supplied. Each importer is required to retain the distribution records for their medical devices for between 5 and 10 years (depending upon the class of medical device) after the last product has been distributed. IMPORTER’S OnGOInG RESPOnSIbILITIES An importer of medical devices that has successfully had a medical device listed on the ARTG has ongoing responsibilities. The importer is required to ensure that an appropriate conformity assessment procedure has been applied to the device. An importer is also required to ensure that sufficient information to substantiate the application of those conformity assessment procedures is available, or that procedures are in place to ensure that such information can be obtained from the manufacturer within 20 working days. There are also guidelines governing the advertising and promotion of therapeutic goods and it is the importer’s responsibility to ensure any advertising material relating to the medical device complies with the TGA requirements. IMPORTAnT nOTE AbOUT MEdICInES, bIOLOGICAL PROdUCTS And LOCALLY MAnUfACTUREd PROdUCTS Please note that the TGA has put in place different arrangements for medicines, biological products (blood products and products of human and/or animal origin) and therapeutic goods manufactured locally. For further information on these, contact the TGA or an appropriately qualified consultant. THE LEGISLATIvE fRAMEWORK CHAnGES SO KEEP UP-TO-dATE! The legislative framework governing the manufacture and supply of therapeutic goods is subject to constant review and it is the responsibility of each manufacturer and importer to monitor such changes and determine how they apply to the company’s operations and the distribution or manufacture of goods. Troy Williams Chief Executive Officer Australian Dental Industry Association On behalf of the ADA Dental Instruments Materials and Equipment (DIME) Committee dISCLAIMER This information is provided for information purposes only and should not be relied upon when determining your company’s statutory obligations. It is recommended that you seek independent expert advice concerning your obligations with respect to the Therapeutic Goods Act (Cth) 1989 and related legislation.
ADA News Bulletin September 2011
ADA News Bulletin November 2011