Country	Organization	Document	Status
International	WHO	Technical Specification Series for submission to WHO Prequalification - Medical device assessment screening and triage of TB using computer aided detection software for interpretation of chest X-Ray images (Rev 11)	Draft
International	WHO	Technical specifications series for submission to WHO prequalification - Malaria rapid diagnostic tests (second edition) (TSS-3)	Draft
International	WHO	Technical specifications series for submission to WHO prequalification - Haemoglobin point of care analysers (TSS-22)	Draft
International	WHO	Technical specifications series for submission to WHO prequalification - Rapid diagnostic tests to detect mycobacterial lipoarabinomannan (LAM) antigen in urine (TSS-23)	Draft
International	WHO	WHO preferred product characteristics (PPC) of blood-based biomarker diagnostics for Alzheimer disease	Draft
International	WHO	Enhanced reliance in WHO Prequalification of IVDs	Final
International	WHO	Eligibility criteria for WHO prequalification of in vitro diagnostics	Final
Australia	TGA	Review of first-in-human high-risk implantable or cardiac invasive medical device clinical trials	Draft
Australia	TGA	Investigator’s brochures for medical device clinical trials	Draft
Australia	TGA	Instructions for Use for Medical Devices - Consultation on availability of instructions for use in more flexible formats (Version 1.0)	Draft
Australia	TGA	Proposed changes to the regulation of exempt medical devices and exempt Other Therapeutic Goods (Version 1.0)	Draft
Australia	TGA	Regulatory requirements for in-house IVDs (Version 3.0)	Final
Australia	TGA	Medical Devices Essential Principles Checklist	Final
Denmark	DMA	Application form for the authorisation for clinical investigations of medical devices	Final
Denmark	DMA	Fees for performance studies of in vitro diagnostic medical devices	Final
Egypt	EDA	Off-site Nursing in Clinical Trials	Draft
EU	MDCG	MDCG 2024-5: Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices	Final
EU	MDCG	MDCG 2024-5 Appendix A: Cross-references between requirements in Annex XV chapter II of the MDR and the Clinical Investigation submission package	Final
EU	MDCG	MDCG 2024-4: Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746	Final
EU	MDCG	MDCG 2024-4 Appendix: Performance Study Summary Safety Reporting Form	Final
EU	MDCG	MDCG 2022-9/Rev.1: Summary of safety and performance Template	Final
Hong Kong	DoH	Medical Device Information System (MDIS) is supporting New Applications for listing Medical Devices and Traders	Final
Japan	PMDA	Questions and Answers (Q&A) on MR Safety of Implantable Medical Devices, etc. (Part 2) [English translation of administrative noticed issued in September 2022]	Final
Netherlands	CCMO	Template research protocol	Final
Pakistan	DRAP	Guidelines for Storage and Destruction of Returned Therapeutic Goods (QALT/GL/DT/008), 1st Edition	Final
Switzerland	Swissmedic	Information sheet - Medical Device Software (Version: 3.0)	Final
Switzerland	Swissmedic	Field Safety Corrective Action (FSCA) Report	Final
UK	MHRA	Clinical investigations of medical devices – guidance for manufacturers	Final
UK	MHRA	Notify MHRA about a clinical investigation for a medical device	Final
UK	MHRA	Medical devices: UK approved bodies	Final
UK	MHRA	Borderlines with medical devices and other products in Great Britain	Final
UK	MHRA	Assistive technology: definitions, examples and safe use	Final
US	FDA	Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency - Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564 - Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff	Draft
US	FDA	Data Standards Catalog (Version 10.3)	Final

Global Medtech Guidance Tracker: April 2024

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