Therapeutic Goods Act 1989

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INTRODUCTION
A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug).[1]

Medical device regulatory system in Australia [2]
 In Australia medical devices are regulated by TGA (Therapeutic Goods Administration).
 The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices.
 As per Therapeutic Goods 1989 Act, therapeutic goods supplied in Australia must meet acceptable standards of quality, safety …show more content…
The higher the class, the more regulatory control is required. Depending on the level of risk, medical devices are classified …show more content…
 In case of direct payment of fees by manufacturer in the country of origin the fees shall be paid through electronic clearance system (ECS), and the original receipt of the said transfer shall be treated as an equivalent to the bank challan, subject to the approval by the Bank of Baroda that they have received the payment.
 DCG(I) implemented user fees for product registration under the Guidelines and accepted many industry recommendations on appropriate categories, or “families” of products. Application for Registration Certificate addressed to the Drug Controller General (India) and deposited at the Resource Center, CDSCO.
 A registration fee of about $US 1500 for the premises where the devices intended to be imported; A registration fee of $US 1000 for a single medical device (which may include variation in sizes or shape without any change in the material or method of use) and an additional fee of US$1000 for each additional device and for duplicate copy 300 $US.

Vigilance
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