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Achieve and maintain your medical device compliance

To ensure the quality, safety, efficacy and performance of medicines and medical devices, the TGA regulates the manufacturers of these products to ensure compliance to the ISO 13485 Medical Devices standard.

Background

Manufacturers and distributors that intend to supply therapeutic goods in Australia must have their products entered onto the Australian Register of Therapeutic Goods (ARTG) before they can lawfully be sold.  To be included on the register these products must have been manufactured by a company that has demonstrated compliance to ISO13485 Medical Devices standard demonstrate equivalence.  ISO 13485 is the most commonly chosen path for medical device companies to meet the quality system requirements in Europe, Canada, Japan, Australia and other countries.

Australian Register of Therapeutic Goods

The Australian Register of Therapeutic Goods (ARTG) is the central point of control for the legal supply of therapeutic goods in Australia.  Sponsors take responsibility for the supply of a medical device in or from Australia.

Relevant standards

  • ISO13485  Medical Devices – Quality Management systems – Requirements for regulatory purposes

ISO 13485:2003 is a quality system standard designed specifically for medical device companies. The ISO 13485 standard supplements ISO 9001 and has many of the same requirements. However, there are additional requirements for process control, design control, retention of records, accountability, traceability and more.

The TGA in collaboration with the medical devices industry sector has developed a consolidated reference document detailing the Australian regulatory requirements for medical devices.

This document has been developed as a guide to assist sponsors and manufacturers understand the regulatory requirements for medical devices in Australia.

Medical devices

These devices are used on humans and are either used to measure or monitor the functions of the body or have a a therapeutic or mechanical effect on the body.

Other examples of medical devices include in vitro diagnostic (IVD) tests used in pathology laboratories, woundcare, artificial hips, blood pressure monitors, breast implants, pace makers, condoms, lubricating eyedrops, CT scanners, Orthodontics – eg braces, fillings, syringes, tongue depressors.

Classes of Medical Device

  • Class I – elastic bandages, tongue depressors, cervical collars, slings, non-sterile dressings
  • Class IIa – X-ray films, intravenous tubing, contact lenses, catheters
  • Class IIb – Blood bags, dressings for severe wounds, condoms
  • Class III – Coronary artery probes, intrauterine contraceptive devices, medical devices that contain medicines, such as dressings with an anti-microbial agent
  • Active implantable medical devices – Pace makers, cochlear implants

In vitro diagnostic medical devices

In vitro diagnostic medical devices (IVDs) are generally pathology tests and related instrumentation used to carry out testing on human samples, where the results are intended to assist in clinical diagnosis or in making decisions concerning clinical management. IVDs are typically used in diagnostic laboratories, at the point of care, and in the home.   IVDs undergo a level of regulatory scrutiny that is commensurate with the risks associated with their use.

In-house IVDs

Laboratory organisations can manufacture and distribute in-house IVDs within their laboratory network. (To be considered a laboratory network they must have a quality management system common to all sites manufacturing and using the in-house IVDs).  The level of regulation is dependent on the class of IVD.  IVD medical devices are classified according to the risk posed to the health of the public or an individual, and relates to the risk of an incorrect result arising from the use of the IVD.

Class 1 IVD – no public health risk or low personal risk
Class 2 IVD – low public health risk or moderate personal risk
Class 3 IVD – moderate public health risk or high personal risk
Class 4 IVD – high public health risk or high personal risk

Laboratories manufacturing Class 1-3 in-house IVDs require compliance with ISO 15189

Laboratories manufacturing Class 4 in house IVDs require the same regulatory compliance as the commercial manufacturers of IVDs,  ISO 13485 Medical Devices – Quality Management systems – Requirements for regulatory purposes.

What are the benefits of meeting medical device compliance?

  • Meeting regulatory requirements.  Without compliance with the ISO13485 requirements the TGA will not enter your product onto the Australian Register of Therapeutic goods which means it will be unlawful to supply your product in Australia.
  • Meeting the needs of the customer, through effective communication regarding products, order handling, feedback and complaints.
  • Reducing errors and associated costs, contamination events and reworks.
  • Improving the confidence in the product for the regulatory bodies, medical professionals and end users.
  • Companies wanting to sell their products in Europe or USA require either a CE Mark (EU) or FDA clearance (USA) for their products and need to complete the applicable conformity assessment procedures depending on the class of the product (EU) or be ready to pass an FDA inspection (US) to the requirements of 21CFR820 QSR.  Meeting the requirements of ISO13485 puts these manufacturers well on the path to meeting the additional requirements.

Call us today to discuss your medical device compliance requirements.