TGA

The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health (link is external), and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products.

Almost any product for which therapeutic claims are made must be entered in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.

As part of the Department of Health, the TGA safeguards and enhances the health of the Australian community through effective and timely regulation of therapeutic goods.

The TGA is responsible for ensuring that therapeutic goods available for supply in Australia are safe and fit for their intended purpose. These include goods Australians rely on every day, such as vitamin tablets and sunscreens, through to goods used to treat serious conditions, such as prescription medicines, vaccines, blood products and surgical implants.

Regulating medical devices

--Classifying the medical device based on different levels of risk to the user

--Assessing compliance with a set of internationally agreed essential principles for their quality, safety and performance

--Implementing appropriate regulatory controls for the manufacturing processes of MD

--Including the medical device in the Australian Register of Therapeutic Goods

--Monitoring MD, if available（A comprehensive adverse event reporting program included.）

Risk management approach to the regulation of:

In vitro diagnostic medical devices (IVDs)

Blood

Blood components

Plasma derivatives

Tissue and cellular products

Tissue and cell based derivatives

Sterilants and disinfectants

Medical devices & IVDs

Medical devices include a wide range of products such as medical gloves, bandages, syringes, condoms, contact lenses, in vitro diagnostic medical devices, disinfectants, X-ray equipment, surgical lasers, pacemakers, dialysis equipment, baby incubators, heart valves.

What is a medical device?

Medical devices:

--are used on humans

--have therapeutic benefits

--generally have a physical or mechanical effect on the body or are used to measure or monitor functions of the body.

--Medical devices range from a bandage that you would put on a scratch to high risk products such as pacemakers that are implanted in your body.

Other examples of medical devices include:

Artificial hips

Blood pressure monitors

Breast implants

Catheters

Condoms

Lubricating eyedrops

MRI scanners

Orthodontics - eg braces, fillings

Syringes

Tongue depressors

From the Therapeutic Goods Act 1989...

(41BD What is a medical device)

A medical device is:

any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:

Diagnosis, prevention, monitoring, treatment or alleviation of disease;

Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;

Investigation, replacement or modification of the anatomy or of a physiological process;

Control of conception;

and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or

an accessory to such an instrument, apparatus, application

ARTG

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.

Once a sponsor has all the necessary information for the medical device/s they want to supply, they can lodge an application with the TGA via TGA e-Business Services (link is external).

What We Do?

--Gap analysis audit

--Pre-assessment audit

--Full or partial internal audit

--Subcontractor or supplier audit

--Document and records control

--Training on regulatory requirements and internal procedures

--Design and development

--Risk management

--Software development (if applicable)

--Supplier evaluation

--Control of measurement equipment

Why Jiushun Management?

Jiushun Management, focused on Medical Device Registration, Certification for 20 years, provided high quality service for more than 5,000 global customers.

The MD industry focus degrees, regulatory familiarity, and rich experience, determine our high efficiency and professionalism.

Our professional technical support, from the early regulations, processes guidance, documentation preparation, to testing assistance, review tracking, as well as years of MD industry resource integration, will greatly shorten the period of your product approval, and well practice our principle "Jiushun Management, create value for you. ".