Country	Organization	Document	Status
International	WHO	WHO guidance for best practices for clinical trials	Draft
International	WHO	Eligibility criteria for WHO prequalification of in vitro diagnostics (Version 7)	Final
International	WHO	Pre-submission form - Prequalification of in vitro diagnostics	Final
International	GHWP	GHWP UDI Rule (GHWP/WG9/P001:2023)	Draft
Australia	TGA	Varying entries in the ARTG - Medical devices and IVD medical devices (Version 4.0)	Final
Australia	TGA	Application for TGA conformity assessment certificates (medical devices)	Final
Australia	TGA	Reclassification of active medical devices for therapy with a diagnostic function - Guidance on the transitional arrangements and obligations (Version 1.2)	Final
Australia	TGA	Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems - Guidance on the transitional arrangements and obligations (Version 1.3)	Final
Australia	TGA	Reclassification of medical devices that administer medicines or biologicals by inhalation - Guidance on the transitional arrangements and obligations (Version 1.3)	Final
Australia	TGA	Reclassification of medical devices that are substances to be introduced into the body or applied to and absorbed by the skin - Guidance on the transitional arrangements and obligations (Version 1.5)	Final
Australia	TGA	Reclassification of spinal implantable medical devices - Guidance on the transitional arrangements and obligations of sponsors and manufacturers (Version 2.5)	Final
Australia	TGA	Active medical devices - Introduction and overview of requirements (Version 1.1)	Final
Australia	TGA	Regulation of software based medical devices	Final
Canada	HC	Pre-market guidance for machine learning-enabled medical devices	Draft
Canada	HC	Medical devices licence amendment minor change form: Guidance for changes to the manufacturer’s name and/or address of existing device licences and/or COVID-19 medical device authorizations	Final
Canada	HC	Guide to authorities under the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law)	Final
EU	EC	Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period	Final
EU	TEAM-NB	Template - Transfer agreement for surveillance of legacy devices specifying the terms of the transfer of the appropriate surveillance activities according to Article 120 (3e) of Regulation (EU) 2017/7451 in respect of legacy devices covered by a certificate issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC	Final
EU	TEAM-NB	Position paper - New MDR Transition Timelines and Notified Body Capacity	Final
Ireland	HPRA	HPRA process for certificates of free sale applications for devices qualifying under Regulation 2023/607	Final
Ireland	HPRA	Application for Certificates for Free Sale (Medical Device Directives: Medical Devices/System and Procedure Packs/Legacy Devices) for Devices Qualifying under Regulation 2023/607	Final
PMDA	Japan	Points to Consider for Informed Consent Using Electromagnetic Means in Clinical Trials and Post-marketing Clinical Trials (Provisional translation)	Final
Malaysia	MDA	Importation of Medical Device for Re-Export (IRE)	Draft
Malaysia	MDA	Wearable Medical Device	Draft
Malaysia	MDA	Importation of medical device for personal use	Draft
Malta	MMA	Guidance on fees in relation to Medical Devices (GL-MDF07/09)	Final
Saudi Arabia	SFDA	Checklist for Quality Manual (In accordance to ISO 13485)	Final
South Africa	SAHPRA	Form - Licence Application To Wholesale Medical Devices	Final
South Africa	SAHPRA	Form - Licence Application to Import, Distribute or Export Medical Devices	Final
South Africa	SAHPRA	Form - Licence Application to Manufacture, Import, Distribute or Export Medical Devices	Final
Switzerland	Swissmedic	swissdamed – Swiss Database on Medical Devices	Final
Switzerland	Swissmedic	Information sheet - Derogation MEP	Final
Switzerland	Swissmedic	Information sheet - Notifications devitalised human tissue	Final
UK	MHRA	MORE Registrations - user reference guide	Final
UK	MHRA	MORE Submissions - user reference guide	Final
UK	MHRA	Notify the MHRA about a clinical investigation for a medical device	Final
UK	MHRA	Medical devices: UK approved bodies	Final
UK	MHRA	How tests and testing kits for coronavirus (COVID-19) work	Final
UK	MHRA	Export medical devices	Final
UK	MHRA	Register medical devices to place on the market	Final
UK	MHRA	Medical devices: guidance for manufacturers on vigilance	Final
US	FDA	Informed Consent - Guidance for IRBs, Clinical Investigators, and Sponsors	Final
US	FDA	Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff	Final

Global Medtech Guidance Tracker: August 2023

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