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 #regulatoryandmore The Shop Share Facebook Twitter Linkedin Whatsapp Envelope Template – Product Qualification and Classification under the EU IVDR 2017/746 (v.1.0) $50.00 Add to cart Checklist – ISO 13485 2016 Internal Audit (v.1.0) $50.00 Add to cart Template – SOP Master Validation Test Plan (v.1.0) $50.00 Add to cart Template – Technical Documentation Table of Content according to the IVDR (v1.0) $50.00 Add to cart Template – SOP Technical Documentation according the IVDR (v1.0) $50.00 Add to cart How to Create a Project Timeline in Simple Steps Read More » How to create a Project Timeline with VisualMaker? Read More » The IVD Product Types: RUO, IUO, GPR, ASR Read More » Claims under the MDR and the IVDR (Art. 7/7) Read More » The Investigational Device Exemption (IDE) Read More » Conformity Assessment Options for Products Failing under the MDR Read More » Follow Us Linkedin Twitter Facebook Instagram