Australia TGA Medical Device Registration Process Explained

PART

Legal basis

The Complete Australian Medical Device Registration Process Explained – Figure 1

Core regulation: Therapeutic Goods (Medical Devices) Regulations 2002 (as amended on 14 December 2024)

Legal framework: based on the Therapeutic Goods Act 1989, which systematically governs the classification, registration and regulation of medical devices

The Complete Australian Medical Device Registration Process Explained – Figure 2

PART 2

Medical device classification

The Complete Australian Medical Device Registration Process Explained – Figure 3

The Complete Australian Medical Device Registration Process Explained – Figure 4

PART 3

Compliance route to registration

The Complete Australian Medical Device Registration Process Explained – Figure 5

Conformity assessment requirements:

Class I devices: compliance can be achieved by self-declaration

Class IIa and higher devices: require conformity assessment by the TGA (Therapeutic Goods Administration) or a body it recognises

Class III/AIMD devices: require a full quality system audit

PART4

Timelines and fees

The Complete Australian Medical Device Registration Process Explained – Figure 6

The Complete Australian Medical Device Registration Process Explained – Figure 7

PART5

Quality management system requirements

The Complete Australian Medical Device Registration Process Explained – Figure 8

Advantages of MDSAP certification: the Medical Device Single Audit Program (MDSAP) simplifies the quality management system audit process, enabling an efficient “one audit, recognised by multiple countries” model.

PART6

Local compliance obligations

The Complete Australian Medical Device Registration Process Explained – Figure 9

Mandatory Australian sponsor: manufacturers based outside Australia must appoint an Australian sponsor (referred to here as the Australian Authorised Representative, ARP) as the legal point of contact with the TGA, responsible for submitting documents and receiving regulatory notices.

The Complete Australian Medical Device Registration Process Explained – Figure 10

PART7

Registration process, illustrated

The Complete Australian Medical Device Registration Process Explained – Figure 11

Determine product status: confirm whether the product is a medical device as defined in section 41BD of the Therapeutic Goods Act 1989
Appoint the responsible party: designate the Sponsor (the applicant)
Determine risk class: classify the product by risk based on its characteristics (Class I to AIMD)
Submit evidence: the Sponsor submits the manufacturer’s evidence documents via the eBS (TGA Business Services) system
TGA pre-assessment: the regulator reviews and accepts the manufacturer’s evidence
Product application: submit the complete product registration application via eBS
Formal assessment:

Approved: TGA registration (ARTG inclusion) granted

Further information requested: submit additional documents after receiving feedback

Application rejected: the TGA will explain the reasons for rejection in writing

The Complete Australian Medical Device Registration Process Explained – Figure 12

PART8

Notes on regulator logos

The Complete Australian Medical Device Registration Process Explained – Figure 13

Official TGA logo: “Therapeutic Goods Administration” (part of the Australian Government Department of Health)

Example certification mark: a combined logo with the words “TGA CERTIFIED”

The Complete Australian Medical Device Registration Process Explained – Figure 14

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The Complete Australian Medical Device Registration Process Explained – Figure 15

About Us

COMPANY INTRODUCTION

EVERBIZ Certification Services (Shanghai) Co., Ltd. (EVERBIZ) is a professional compliance service platform for testing, certification, consulting and training of medical products, dedicated to helping leading medical R&D companies at home and abroad improve their compliance capabilities and competitiveness. The company has offices and branches in Shanghai (China), Hong Kong, Munich (Germany), Salzburg (Austria) and Thailand, covering nearly 25 industries of compliance products (such as medical devices, new energy, household appliances, lighting, tools, laboratory instruments, machinery, in vitro diagnostics, wireless products and reagents).

The Complete Australian Medical Device Registration Process Explained – Figure 16

Our Offices

COMPANY ADDRESS

Shanghai: Room 705, Building 6, Lane 111, Luxiang Road, Baoshan District, Shanghai | Germany: Landsberger Str. 155, 80687 München, Germany

Austria: Innsbrucker Bundesstraße 136/3, 5020 Salzburg, Austria

Hong Kong: Room A1, 11/F Winner Building, 36 Man Yue Street, Hung Hom, Kowloon, Hong Kong

Thailand: No. 850 Soi Lat Krabang 30/5, Lat Krabang Subdistrict, Bangkok 10520

The Complete Australian Medical Device Registration Process Explained – Figure 17

The Complete Australian Medical Device Registration Process Explained – Figure 18