Products and equipment for medical purposes, due to the increased risk to human health, belong to the category of important objects of technical regulation. This determines the complexity of certification in this sphere of production and sales: supervisory authorities pay increased attention to goods for medical purposes.

Medical product approvals in Australia

The use of specialised products for medical purposes in Australia is subject to registration. This process occurs through documentation to the Australian regulatory authority as well as a certificate of compliance for the specific medical device.

If necessary, a letter of waiver is also issued to show that the law does not require mandatory certification of this type of medical device.

The list of medical devices approved for use in Australia includes:

• Aortic stents
• Aortic valve insertors
• Dental implants
• Dental sutures
• Endoscope
• Endotracheal tubes
• Endoscopes
• Endonasal guidewires
• Endocardic catheters

Medical device compliance consultants

Organisation of experts of compliance consultants and of medical device regulation in Australia

The Australian Association of Health Practitioners and Officials in Regulation of Medical Devices (AAHPMRD) was established in 2003.

By creating an official liaison between practitioners and regulatory authorities in Australia, AAHPMRD aims to promote, monitor and regulate the activities of all organisations involved in the sale, distribution and monitoring of medical products.

Federation of Medical Technology and Health Officers

The Federation of Medical Technology and Health Officers (FMTHOE) is responsible for maintaining close contacts with the Australian Medical Device Authority (AMDA) and other agencies involved in compliance with the regulations of medical devices in Australia.

FMTHOE also aims to maintain communication and exchange information among the members of Australia’s international organisations.

FMTHOE is composed of compliance consultants and medical device regulation experts.

The Federation of Medical Technology and Health Officers represent the majority of Australia’s doctors as members of the Pharmaceutical Society of Australia and the Royal Pharmaceutical Society of Australia.

Their mission is to maintain the integrity of the medical device system and to enhance patient safety.

There are a number of advantages to using biological implants for surgical procedures. These advantages include reduced reliance on general anaesthesia and no need to have the patient undergo surgery for implantation of the implantation device.

There is also a high level of reliability for the integrity of the implant. This results in fewer follow-up visits for implantation and no need for repeated implantations for patient compliance.

• Aortic stents
• Conductive plastics
• Coronary tissue stents

Medical device compliance specialists

Medical device regulation is changing due to the strong demand for better quality products as well as the introduction of new medical technology.

The role of medical device compliance consultants is changing as medical devices become increasingly sophisticated.

Medical devices come with their own manufacturers as well as medical device compliance consultants.

The demand for medical device compliance consultants, in particular, is increasing due to the complexity of certification and compliance requirements for medical devices.

Medical device regulation specialists are now required to keep up with the increasing demand of manufacturers and compliance consultants in terms of the scope of work for certifying medical devices.

The issue with compliance is that the same consultant will have to keep up with the expanding scope of work for certification and comply with the growing demands of the medical device industry.

Summary

Medical device regulation in Australia ensures the compliance of all involved parties with the regulations.

The complexity of medical device regulations means that compliance consultants need to work with compliance experts, consultants and regulators.

There are many examples of medical device compliance certifications across a wide range of devices and countries.

As this area develops, the regulations will further improve to meet the new requirements of medical technology, in general.

To help medical device regulation, consult with medical device compliance consultants to find out about the requirements for a medical device certification.