Membership Criteria for Organisations and other Institutions
Dental Product Regulatory Standards
The International Association for Dental Quality (IADQ) is subject to numerous standards, many of which are enforced by the International Standard (ISO), Australian Standard (AS), joint Australian / New Zealand Standard (AS/NZS), European Standard (CEN) or an American Standard (ANSI). IADQ carries out a range of assessment and monitoring activities to ensure that its members’ products are of an acceptable standard. .
Overview Of The Regulatory Environment
The International Association for Dental Quality (IADQ) works with its members to make sure that the products supplied by the dental industry must be safe and comply with the standards and regulations designed to achieve this outcome. IADQ expects that medicines and medical devices provided by its members are safe and of high quality, and of a standard at least equal to that of comparable countries. The objective of the IADQ products standardisation is to provide an international framework for the regulation of dental products to ensure the quality, safety and efficacy of medicines and ensure the quality, safety and performance of dental devices.
Key standards requirements
Most types of equipment need to be manufactured in accordance with the relevant product technical standard which many include an International Standard (ISO), Australian Standard (AS), joint Australian / New Zealand Standard (AS/NZS), European Standard (CEN) or an American Standard (ANSI). Manufacturers of therapeutic devices must ensure that they comply with all applicable rules and regulations that relate to the operation or supply of their device in their country, regardless of whether the requirements directly relate to medical regulatory aspects or not. Depending on the piece of equipment these technical standards may govern the design, manufacture, installation, calibration and maintenance of equipment. In many cases these standards will be referenced in regulations thus compliance with the standards is mandated by law.
For a medical (dental) device to meet the IADQ standards requirements, 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 they have met the Essential Principles. The most common way to demonstrate compliance with the Essential Principles is to meet a standard published by a national or International Standards agency, or a similar standard. General principles for medical devices are:
- 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.
The principles about design and construction include:
- 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. An importer must ensure that the medical devices that they import comply with the Essential Principles and that they have available sufficient information to substantiate that compliance with the Essential Principles or have procedures in
place, including a written agreement, to ensure that such information can be obtained from the manufacturer within twenty working days. The IADQ may request this information at any time without the need to show cause as to why they require the information.
Regulatory Compliance – Responsible persons
IADQ requires that each manufacturer be responsible for ensuring that the piece of dental equipment complies with the requirements of the legislation and is supplied in the same fashion.
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