Country	Organization	Document	Status
International	WHO	WHO Global Model Regulatory Framework for medical devices including IVDs (GMRF) (WHO/GMRF/DRAFT/2 May 2022)	Draft
International	IMDRF	Machine Learning-enabled Medical Devices: Key Terms and Definitions (IMDRF/AIMD WG/N67)	Final
International	IMDRF	Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form (IMDRF/NCAR WG/N14FINAL:2022 (Edition 3))	Final
Australia	TGA	Seasonal Influenza Rapid Antigen Self-tests and Combination tests: Clinical performance requirements and risk mitigation strategies (Version 2.0)	Final
Australia	TGA	Testimonials and endorsements in advertising	Final
Denmark	DMA	Deregistration of medical devices	Final
Denmark	DMA	Certificates of Free Sale to Danish manufacturers of medical devices	Final
Ethiopia	EFDA	Guidelines for Medical device manufacturer’s Good Manufacturing Practices site inspection management (First edition)	Final
Ethiopia	EFDA	Guidelines for Medical Device Labeling (First edition)	Final
Ethiopia	EFDA	Guideline for Medical Devices Good Clinical Practice (First edition)	Final
EU	EC	Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for In Vitro Diagnostic Medical Devices	Final
EU	MDCG	MDCG 2022-10 - Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746	Final
EU	MDCG	MDCG 2022-9 - Summary of safety and performance template	Final
EU	MDCG	MDCG 2022-8 - Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022	Final
EU	MDCG	MDCG 2022-7 - Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746	Final
EU	MDCG	MDCG 2022-6 - Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR	Final
India	CDSCO	Updated list of Laboratories for conducting Performance Evaluation of In-Vitro Diagnostic Medical Device	Final
India	CDSCO	List of Laboratories for conducting Performance Evaluation of In-Vitro Diagnostics Medical Device (Analyzer, Instrument and software)	Final
India	CDSCO	Final General Statutory Rules (GSR) 356(E) -Insert rule 43A for Suspension and cancellation of license in MDR 2017	Final
Ireland	HPRA	Form - Request for performance study pre-submission meeting	Final
Ireland	HPRA	Application for a performance study	Final
Malaysia	MDA	Personal Protective Equipment (PPE) – Requirements (MDA/GD/0058), 2^nd Edition	Final
Malaysia	MDA	Guidance on the rules of classification for general medical devices (MDA/GD/0009), 2^nd Edition	Final
Pakistan	DRAP	Statutory Regulatory Order (SRO) 559(I)/2022 (Amendments in the Medical Devices Rules, 2017)	Final
Philippines	FDA Philippines	Updated Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2020-0017	Draft
Philippines	FDA Philippines	Annex A (Requirements for License to Operate) - Updated Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2020-0017	Draft
Philippines	FDA Philippines	Annex B (Qualified Person Qualification and Credential Requirements) - Updated Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2020-0017	Draft
Philippines	FDA Philippines	Annex C (List of Requirements for Specific Variation in the LTO) - Updated Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2020-0017	Draft
Philippines	FDA Philippines	FDA Circular - Good Storage and Distribution Practices for Medical Devices	Draft
Singapore	HSA	GN-09: Guidance on the Component Elements of a Dear Healthcare Professional Letter (Revision 3.6)	Final
Singapore	HSA	GN-09 R3.6 Annex 1: “Dear Healthcare Professional” Letter Format	Final
Singapore	HSA	Request for unregistered medical device for use on patients by qualified practitioner/licensed healthcare facility (MDSA-HCP, Version 2)	Final
Switzerland	Kofam	Clinical trials with medical devices, including in-vitro diagnostic products: changes in the legal requirements	Final
Switzerland	Swissmedic	New regulations applicable to in vitro diagnostic medical devices as of 26 May 2022	Final
Switzerland	Swissmedic	Performance studies with IVD	Final
Switzerland	Swissmedic	Information sheet - Performance studies with IVD	Final
Switzerland	Swissmedic	Information sheet - Clinical investigations with medical devices	Final
UK	MHRA	Notify the MHRA about a clinical investigation for a medical device	Final
UK	MHRA	Medical devices: UK approved bodies	Final
US	FDA	Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program: Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus: Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised): Guidance for Industry and Food and Drug Administration Staff	Final

Global Medtech Guidance Tracker: May 2022

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