The Therapeutic Goods Administration (TGA) controls medical devices in Australia according to criteria prescribed by the Therapeutic Goods (Medical Devices) Regulations 2002. The regulatory environment in Australia is quite similar to that in Europe. Indeed, if a device has the European CE Marking, the classification will probably be consistent and the approval process will be easier since the CE Marking is generally accepted by the TGA.

Chapter Contents:

• 4.1 Regulatory environment and approval process in Australia
• 4.2 Regulatory environment and approval process in Brazil
• 4.3 Regulatory environment and approval process in Canada
• 4.4 Regulatory environment and approval process in China
• 4.5 Regulatory environment and approval process in Japan
• 4.6 Regulatory environment and approval process in Russia

Inspec keywords: law; medical supplies

Other keywords: TGA; regulatory environment; therapeutic goods administration; Australia; Therapeutic Goods Regulations; European CE Marking; medical devices

Subjects: Legal aspects; Medical equipment and supplies industry