Regulatory Knowledge At A Glance

Regulatory Landscape

Resource Center

International

Key laws, acts, regulations, directives, guidelines, guidance documents, standards and other relevant resources for business development and regulatory professionals in the medical industry.

The International Medical Device Regulators Forum (IMDRF)

IMDRF is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonization and convergence.

World Health Organization (WHO) - Medical Devices

Factsheets, Guidelines and Databases

ISO

ISO is an independent, non-governmental international organization with a membership of 167 national standards bodies developing International Standards.

TGA Australia

The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods.

The role of the TGA in digital health

TGA Australia
WEBINAR

Good Manufacturing Practice (GMP)

TGA Australia
WEBINAR

The Good Manufacturing Practice (GMP) Framework

TGA Australia
WEBINAR

Meeting Your Obligations

TGA Australia
WEBINAR

Good Manufacturing Practice (GMP) Clearance Applications - Common pitfalls

TGA Australia
WEBINAR

Special Access Scheme Portal - Information for Healthcare Professionals

TGA Australia
WEBINAR

Unique Device Identification #1

TGA Australia
WEBINAR

Unique Device Identification #2

TGA Australia
WEBINAR

Unique Device Identification #3

TGA Australia
WEBINAR

Unique Device Identification #4

TGA Australia
WEBINAR

Unique Device Identification #5

TGA Australia
WEBINAR

Unique Device Identification #6

TGA Australia
WEBINAR

Application for consent to import, supply, or export a medical device non-compliant with the Essential Principles #1

TGA Australia
WEBINAR

Application for consent to import, supply, or export a medical device non-compliant with the Essential Principles #2

TGA Australia
WEBINAR

Advertising Code public information session

TGA Australia
WEBINAR

Democratizing MedTech Regulatory Knowledge

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