Country	Organization	Document	Status
International	WHO	Technical specifications series (TSS) 20: In vitro diagnostic medical devices used for the qualitative detection of SARSCoV-2 nucleic acid	Draft
International	WHO	Technical specifications series (TSS) 21: SARS-CoV-2 antigen rapid diagnostic tests for professional use and self-testing	Draft
International	IMDRF	Guiding Principles to Support Medical Device Health Equity (IMDRF/MC/N79 DRAFT: 2023)	Draft
Australia	TGA	Review of regulatory requirements for medical devices containing materials of animal, microbial or recombinant origin (Version 1.0)	Draft
Australia	TGA	Transition to new manufacturer evidence for IVD medical devices - Guidance for manufacturers and sponsors of IVD medical devices (Version 1.0)	Final
Australia	TGA	Use of market authorisation evidence from comparable overseas regulators/assessment bodies for medical devices (including IVDs) - For abridgement of TGA conformity assessments and as information required for applications for ARTG inclusion (Version 1.9)	Final
Australia	TGA	Reclassification of spinal implantable medical devices - Guidance on the transitional arrangements and obligations of sponsors and manufacturers	Final
Australia	TGA	Reclassification of surgical mesh devices	Final
Australia	TGA	Guidance for completing a notification form for lapses in medical device conformity assessment certification (Version 1.1)	Final
Australia	TGA	The TGA’s approach to delays in medical device conformity assessment recertification - Due to COVID-19 pandemic and implementation of EU MDR/IVDR (Version 1.3)	Final
Australia	TGA	COVID-19 rapid antigen tests - Guidance on performance requirements and risk mitigation strategies (Version 3.0)	Final
Czech Republic	SÚKL	UST-29 Administrative fees, reimbursements of costs of expert activities, reimbursements of activities associated with the provision of information and reimbursements of other activities (version 24)	Final
Denmark	DMA	Notified bodies	Final
Denmark	DMA	New medical devices regulations	Final
Ethiopia	EFDA	Guideline on Medical Products Special import permit	Final
EU	MDCG	MDCG 2022-18 ADD.1 - MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate	Final
India	CDSCO	General Statutory Rule (GSR) 409(E) - Medical Devices	Final
Malaysia	MDA	MDA Approach on Expired EC Certificate for New Registration and Re-registration of Medical Device	Final
Philippines	FDA Philippines	Updated Guidelines on the Application for License to Operate of Health Product Establishments with the Food and Drug Administration	Draft
Switzerland	Swissmedic	Request to check mandates relating to ECM certifications	Final
Switzerland	Swissmedic	Medicinal products with a medical device component (combination products)	Final
UK	MHRA	Regulatory status of equipment being used to help prevent coronavirus (COVID-19)	Final
UK	MHRA	Borderlines with medical devices and other products in Great Britain	Final
UK	MHRA	Implementation of medical devices future regime	Final
UK	MHRA	How tests and testing kits for coronavirus (COVID-19) work	Final
UK	MHRA	Approved bodies for medical devices	Final
UK	MHRA	Medical devices regulations: compliance and enforcement	Final
UK	MHRA	Medical devices: off-label use	Final
UK	MHRA	Assistive technology: definitions, examples and safe use	Final
UK	MHRA	Regulating medical devices in the UK	Final
UK	MHRA	Virtual manufacturing of medical devices	Final
UK	MHRA	Medical devices: legal requirements for specific medical products	Final
UK	MHRA	Register medical devices to place on the market	Final
UK	MHRA	DEHP phthalates in medical devices	Final
UK	MHRA	Software and AI as a Medical Device Change Programme	Final
UK	MHRA	Notify the MHRA about a clinical investigation for a medical device	Final
US	FDA	Patient-Matched Guides to Orthopedic Implants - Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program - Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff	Final
US	FDA	Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Guidance for Industry and Food and Drug Administration Staff	Final

Global Medtech Guidance Tracker: June 2023

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