/

/

United States legal-change intelligence across legislation, regulation, and case law. Separate data plane, same Zoe spine.

Platform

Legislation
Cases
Ask Zoe

Company

Pricing
API
X
LinkedIn
Instagram

Jurisdictions

Federal
Supreme Court
Alabama

District of Columbia

© 2026 Zoe. All rights reserved.

Zoe is a legal information platform. Always consult the official source for authoritative text.

Legislation Cases Absurdities Ask Zoe Graph Pricing

Home/Legislation/Therapeutic Goods (Medical Devices) Regulations 2002/14

CTHIn ForceLegislation

Therapeutic Goods (Medical Devices) Regulations 2002

14Clinical evidence

Start here

Get a plain-English read of 14

Turn the raw legal text into a practical explanation grounded in Therapeutic Goods (Medical Devices) Regulations 2002.

View in full context

#### 14 Clinical evidence Every medical device requires clinical evidence, appropriate for the use and classification of the device, demonstrating that the device complies with the applicable provisions of the essential principles. > Note: See regulation 3.11 and the clinical evaluation procedures.

Previous section13C.5UDI device identifier and UDI production identifier to be directly marked on UDI medical device Next section15Principles applying to IVD medical devices only

Section 14 - Therapeutic Goods (Medical Devices) Regulations 2002 - Clinical evidence — Zoe