Country	Organization	Document	Status
International	IMDRF	Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews (IMDRF/GRRP WG/N66 FINAL:2024 (Edition 2))	Final
International	IMDRF	Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews (IMDRF/GRRP WG/N63 FINAL:2024 (Edition 2))	Final
International	IMDRF	Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews (IMDRF/GRRP WG/N61 FINAL:2024 (Edition 2))	Final
International	IMDRF	Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews (IMDRF/GRRP WG/N59 FINAL:2024 (Edition 2))	Final
International	IMDRF	Principles of Labelling for Medical Devices and IVD Medical Devices (IMDRF/GRRP WG/N52 FINAL:2024 (Edition 2))	Final
International	IMDRF	Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (IMDRF/GRRP WG/N47 FINAL:2024 (Edition 2))	Final
International	IMDRF	Competence, Training, and Conduct Requirements for Regulatory Reviewers (IMDRF/GRRP WG/N40 FINAL:2024 (Edition 2))	Final
International	IMDRF	Medical Device Regulatory Review Report: Guidance Regarding Information to be Included (IMDRF/GRRP WG/N71 FINAL:2024 (Edition 2))	Final
International	IMDRF	Annex A: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Medical Device Problem	Final
International	IMDRF	Annex B: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Type of Investigation	Final
International	IMDRF	Annex C: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Investigation Findings	Final
International	IMDRF	Annex D: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Investigation Conclusion	Final
International	IMDRF	Annex E: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Health Effects - Clinical Signs and Symptoms or Conditions	Final
International	IMDRF	Annex F: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Health Effects - Health Impact	Final
International	IMDRF	Annex G: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Medical Device Component	Final
International	IMDRF	Appendix B: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Change Log	Final
Australia	TGA	Legal supply of COVID-19 test kits	Final
Australia	TGA	Q&As on conditions of supply for rapid antigen point of care COVID-19 tests	Final
Australia	TGA	Good Clinical Practice (GCP) Inspection Program	Final
Australia	TGA	Notification of a change in sponsorship	Final
Australia	TGA	Regulation of software based medical devices	Final
Australia	TGA	Guidance on boundary and combination products (Version 2.0)	Final
Australia	TGA	Examples of boundary and combination products and their product category (Version 2.0)	Final
Canada	HC	Cancellation of MDELs for non-compliance with annual licence review requirements	Final
Denmark	DMA	Requirement for information on medical devices to be in Danish	Final
Denmark	DMA	Fees paid for clinical investigations of medical devices	Final
Denmark	DMA	End of clinical investigation	Final
Denmark	DMA	Clinical Investigations – Reporting of SAEs	Final
Denmark	DMA	Clinical Investigations – Application for authorisation of substantial modifications	Final
Denmark	DMA	Clinical Investigations – Notification of PMCF investigation	Final
Denmark	DMA	Clinical Investigations – Information about the assessment	Final
Denmark	DMA	Clinical Investigations – Application for an authorization	Final
Denmark	DMA	Clinical Investigations – Notification duty	Final
Denmark	DMA	Clinical investigation of medical devices	Final
EU	EMA	Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746) (EMA/37991/2019), Rev 4 [Track version]	Final
EU	MDCG	MDCG 2022-4 Rev 2: Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD	Final
EU	MDCG	MDCG 2024-6: Preliminary re-assessment review (PRAR) template – MDR (Regulation (EU) 2017/745)	Final
EU	MDCG	MDCG 2024-7: Preliminary assessment review (PAR) template – MDR (Regulation (EU) 2017/745)	Final
EU	MDCG	MDCG 2024-8: Preliminary assessment review (PAR) template – IVDR (Regulation (EU) 2017/746)	Final
EU	MDCG	MDCG 2024-9: Preliminary re-assessment review template – IVDR (Regulation (EU) 2017/746)	Final
Hong Kong	DoH	Overview of the Medical Device Administrative Control System (GN-01:2024-2(E))	Final
India	CDSCO	Circular – Regulation of all Class C & D Medical Devices under Licensing regime	Final
India	CDSCO	Circular – Retention of license or certificates under Medical Devices Rules, 2017	Final
India	CDSCO	Circular – Testing and evaluation of Medical Devices/In-Vitro Diagnostics by Medical Devices Testing Laboratory in the Country	Final
Ireland	HPRA	Guide for Health Institutions that Manufacture and Use In-house in vitro Diagnostic Medical Devices in Ireland (SUR-G0052-1)	Final
Ireland	HPRA	Guide to Clinical Investigations carried out in Ireland (AUT-G0095-7) [Track version]	Final
Japan	PMDA	Regulatory Science Strategy Consultation - FAQs	Final
Malaysia	MDA	Change notification for registered medical device (MDA/GD/0020), Fifth Edition	Draft
Pakistan	DRAP	Introduction of new Case Management System	Final
Saudi Arabia	SFDA	SFDA Recognized Standards (Supporting Medical Device Premarket Submissions) (MDS – G020), Version 3.0	Final
Saudi Arabia	SFDA	Form - Authorization to open overseas manufacturer account for SFDA’s Unified Electronic System (GHAD)	Final
South Africa	SAHPRA	Guidelines on the traceability of health products (SAHPGL-INSP-RC-04_v1)	Draft
South Africa	SAHPRA	Expression of interest for medical device registration voluntary feasibility study	Final
South Africa	SAHPRA	Annual retention fee payment notification for year ending 31 December 2024	Final
Switzerland	Swissmedic	Announcements on performance studies with vitro diagnostic medical devices	Final
Switzerland	Swissmedic	Information sheet - Performance studies with IVD (Version 3.5)	Final
Switzerland	Swissmedic	Information sheet - Clinical investigations with medical devices (Version 4.4)	Final
UK	MHRA	Common Specification Requirements for In Vitro Diagnostic Devices	Draft
UK	MHRA	COVID-19 test approval: how to apply	Final
UK	MHRA	Implementation of medical devices future regime	Final
UK	MHRA	Medical devices regulations: compliance and enforcement	Final
UK	MHRA	Software and artificial intelligence (AI) as a medical device	Final
UK	MHRA	AI Airlock: the regulatory sandbox for AIaMD	Final
UK	MHRA	Medical devices: UK approved bodies	Final
US	FDA	Remanufacturing of Medical Devices - Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff	Final

Global Medtech Guidance Tracker: May 2024

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