You might be wondering why the rules that apply to various medical devices are different. This is because the rules depend on how your product is classified by the Therapeutic Goods Administration (TGA). For the most part, the classifications are related to the perceived risk of the product type. The Australian regulatory body has defined several different classifications for medical devices. If you have a basic understanding of medical device classifications, it will be easier for you to bring new products to market.
In this article, you will know and familiarise a step-by-step approach to determining how your medical devices will be classified.

Classification of Medical Devices

Medical devices are divided into five major classifications, depending on the level of risk they pose, their purpose, what part of the body they will be used, how long they will be used for, and many other factors.

Class I – The first classification is for low-risk medical devices such as surgical retractors and tongue depressors.

Class I sterile, Class I with a measuring function, Class IIa – The second classification is for low to medium risks medical devices such as sterile surgical gloves, dental drills, ultrasound machines, medicine cup with specific units of measurement, and digital or infrared thermometers.

Class IIb – The third classification is for medium to high-risk medical devices such as surgical lasers and diagnostic X-rays.

Class III – The fourth classification is for high-risk medical devices such as prosthetic heart valves, absorbable surgical sutures, and hip prostheses.

AIMD - The fifth classification is for Active Implantable Medical Devices, which are sometimes treated as Class III. Examples include pacemakers and an artificial heart.

The Classification Rules

While medical devices are classified at the highest applicable classification, multiple classification rules may apply to any given medical device. These classification rules are outlined in the Australian Regulatory Guidelines for Medical Devices (ARGMD) and are prescribed in Schedule 2 and Schedule 2A of the TGA medical device regulations.

Rule 2 Non-invasive Medical Devices

Rule 2.1 Non-invasive medical devices – general

Generally, this rule applies to all medical devices that are not covered by a specific rule, that contact intact skin, and that don’t touch the patient. Some examples include urine collection bottles, wound drainage collection bottles, non-sterile dressings, and gravity traction devices.

Rule 2.2 Non-invasive medical devices designed to channel or store blood

This rule applies to medical devices that may be indirectly invasive (e.g. intravenous tubing, syringes for infusion pumps, blood transfusion sets, and oxygen tubing and masks).

Rule 2.3 Non-invasive medical devices designed to modify the biological or chemical composition of blood

This rule applies to medical devices that are indirectly invasive. These devices are used to treat or modify substances that will be delivered into the body. Some of them are hemodyalyzers, autotransfusion systems, and devices used to separate cells.

Rule 2.4 Non-invasive medical devices designed to have contact with injured skin

This rule applies to wound dressings regardless of the wound depth. The technology associated with these devices is well understood and does not pose any hazard to the patients. Some examples include adhesives, polymer film dressings, absorbent pads, gauze dressings, and dressings that provide a temporary skin substitute.

Rule 3 Invasive Medical Devices

Rule 3.1 Invasive devices used to penetrate body orifices

This rule covers medical devices that enter the body through existing body orifices such as ear mouth, nose, and eye, and surgically created stomas. Under this rule are devices intended for diagnostic and therapeutic use in particular specialties: ophthalmology, dentistry, proctology, urology, and gynaecology. Some devices include dental impression materials, contact lenses, artificial eye and urethral stents, and fixed dental prostheses.

Rule 3.2 Surgically invasive devices intended for transient use

This rule covers medical devices that are used to create a conduit through the skin, surgical instruments, and different types of catheters, suckers, and more. Under this rule are suture needles, hypodermic needles and syringes, cardiovascular catheters, tissues clamp, tissue forceps, fibrin-based tissue glues, and more.

Rule 3.3 Surgically invasive devices intended for short-term use

This rule covers medical devices that are used in the context of surgery or post-operative care, infusion devices, and catheters of various types (e.g. skin closure devices, surgical retractors, intravenous cannula, cardiovascular catheters, neurological catheters, and absorbable sutures).

Rule 3.4 Implantable devices, and surgically invasive devices for long-term use

This rule covers implants that are used in orthopaedic, dental, ophthalmic, and cardiovascular fields. The rule also covers soft tissue implants that are used in plastic surgery (e.g. implantable joint replacements, dental filling materials and pins, prosthetic heart valves, joint replacements, dental filling materials and pins, bioactive adhesives and implants, and rechargeable non-active drug delivery systems.)

Rule 4 Active Medical Devices

Rule 4.1 Active medical devices – general

This rule covers active medical devices that are not under a specific rule (e.g. examination lights, surgical microscopes, diagnostic devices for thermography, and active devices for recording.)

Rule 4.2 Active medical devices for therapy

This rule covers medical devices that are used in surgery (electrical equipment), specialised treatment, and stimulation devices, which include muscle stimulator, cryosurgery equipment, phototherapy for skin treatment and neonatal care, hearing aids, surgical lasers, therapeutic cyclotrons, linear accelerators, and therapeutic X-ray sources.

Rule 4.3 Active medical devices for diagnosis

This rule covers medical devices that are used in ultrasound diagnosis and capture physiological signals and medical devices that are used in therapeutic and diagnostic radiology. Some of these devices are magnetic resonance equipment, gamma cameras, electrocardiographs, intensive care monitoring systems, and diagnostic X-ray sources.

Rule 4.4 Active medical devices designed to administer or remove medicines, etc. from a patient’s body.

This rule covers anaesthesia equipment and drug delivery systems such as suction equipment, anaesthesia machines, dialysis equipment, pressure regulators for medical gases, medical gas mixers, and moisture exchangers in breathing circuits.

Rule 5 Special Rules for Medical Devices

Rule 5.1 Medical devices incorporating a medicine

This rule applies to medical devices that incorporate a medicinal substance, including stable derivatives of human blood and blood plasma that assists the function of the device. Some of these are antibiotic bone cement, condoms with spermicide, and heparin-coated catheters.

Rule 5.2 Medical devices for contraception or prevention of sexually transmitted diseases

This rule covers some devices that may perform both functions such as condoms, contraceptive diaphragms, contraceptive intrauterine devices, and surgically implanted contraceptive devices.

Rule 5.3 Medical devices designed for disinfecting, cleaning, and rinsing

This rule covers different contact lens fluids and substances or equipment to disinfect another medical device. The rule does not apply to devices that clean by a physical action only. Some of these devices are contact lens solutions, comfort solutions, and sterilisers for medical devices.

Rule 5.4 Non-active medical devices intended to record X-ray diagnostic images

This rule covers non-active medical devices that are used to record X-ray diagnostic images such as X-ray films and photostimulable phosphor plates.

Rule 5.5 Medical devices containing non-viable animal tissues or derivatives

This rule covers medical devices that contain animal tissues that have been rendered non-viable or derivatives from such tissues also being non-viable. Some of these devices include biological heart valves, implants and dressings made from collagen, intra-ocular fluids, meniscal joint fluid replacement, and tissue fillers based on hyaluronic acid derived from bacterial fermentation processes.

Rule 5.6 Medical devices that are blood bags

This rule covers blood bags. But if the blood bags have a function greater than storing purposes and include systems for preservation other than anti-coagulants, then other rules (e.g. Rule 5.1) may apply.

Rule 5.7 Active implantable medical devices

Active implantable medical devices are classified as Class AIMD. Some of these devices are electrode leads associated with pacemakers, defibrillators, and nerve stimulators.

Rule 5.8 Medical devices for export only

This rule covers medical devices that are intended by the manufacturers for export (Class I).

Rule 5.9 Medical devices that are mammary implants

This rule covers a medical device that is a mammary implant (Class III).

Key Points to Remember

Knowing how the medical device classification is important. The product classification will determine what you need to do before you can sell a product. It will help you identify requirements during the product development phase, specifically design controls. Most importantly, product classification is an important part of determining how much it will cost to bring your device to the market and providing you with an idea of how long the process will take.

If you want to keep up with the latest regulatory changes, have your devices consulted by Vicki Partridge. As someone who has been with the Therapeutic Goods Administration for quite some time, she knows the ins and outs of the industry. She will provide you with a comprehensive and reliable medical device consulting service.

Visit the services page on her website https://vickipartridge.com and see what you can benefit from the services she offers.