Country	Organization	Document	Status
International	GHWP	Guidance on the Risk-Based Approach to Quality Management System Aspects: ISO 13485:2016 (GHWP/WG7/PF004:2023)	Final
International	GHWP	Guidance for Additional Considerations to support Conformity Assessment of In vitro Companion Diagnostic Medical Devices (GHWP/WG2/PF001:2023)	Final
International	GHWP	A Guide to Understanding Best Practices in Audit Life Cycle Management (GHWP/WG7/PF001:2023)	Final
International	GHWP	Guidance to Supplier Audit for Medical Device Manufacturers (GHWP/WG7/PF003:2023)	Final
International	GHWP	GHWP UDI Rule (GHWP/WG9/PF001:2023)	Final
International	GHWP	A Guide to Understanding Presently Available Audit Duration Determination Systems (GHWP/WG6/PF002:2023)	Final
International	GHWP	Post Market Resource Center (GHWP/WG4/PF001:2023)	Final
International	GHWP	Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU) (GHWP/WG1-WG2-WG3/PD002:2023)	Final
Australia	TGA	Australian declaration of conformity templates (IVDs)	Final
Australia	TGA	Chlamydia, gonorrhoea and syphilis IVD self-tests - Clinical performance requirements and risk mitigation strategies (Version 1.1)	Final
Australia	TGA	Hepatitis B and C viruses IVD self-tests - Clinical performance requirements and risk mitigation strategies (Version 1.1)	Final
Australia	TGA	Software for use with COVID-19 rapid antigen self-tests - Guidance on regulatory requirements (Version 1.3)	Final
Australia	TGA	Clinical evidence guidelines for medical devices (Version 3.2)	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 1.10)	Final
Australia	TGA	Advertising compliance self-assessment checklist	Final
Australia	TGA	Medical device conformity assessment application - Information and forms about applications for TGA conformity assessment certificates	Final
Australia	TGA	Australian Regulatory Guidelines for Medical Devices (ARGMD)	Final
Canada	HC	Implementing the regulatory enrolment process (REP) for medical devices regulatory activities: Revised notice	Final
Canada	HC	What medical device establishment licence holders need to know about annual licence review for 2024	Final
EU	MDCG	MDCG 2022-11 Rev.1 - MDCG Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements	Final
Hong Kong	DoH	GN-10: Guidance Notes on Changes for Listed Medical Devices (GN-10:2023(E))	Final
Malta	MMA	Notice - Product Notification relevant to Medical Device Regulatory Sciences in Malta	Final
Philippines	FDA Philippines	Guidelines on the Use of the Food and Drug Administration eServices Portal System for the Initial Application of a Certificate of Medical Device Notification (CMDN)	Draft
Saudi Arabia	Saudi FDA	Guidance on Saudi Food and Drug Authority Policy for Engagement with Healthcare Practitioners (MDS – G017), Version 1.0	Final
Saudi Arabia	Saudi FDA	Guidance on Saudi Food and Drug Authority Policy for Collection of Patient Experience Data (MDS – G018), Version 1.0	Final
Saudi Arabia	Saudi FDA	Guidance on Saudi Food and Drug Authority Policy for Engagement with Patients (MDS – G019), Version 1.0	Final
Singapore	HSA	Change Notification applications arising from the EU MDR/IVDR related changes to registered medical devices	Final
South Africa	SAHPRA	Guideline for Medical Device Vigilance: Adverse Events Reporting for Licensed Holders (SAHPGL-MD-03_v4)	Draft
South Africa	SAHPRA	Guideline for completing medical device adverse event form for licensed holders (SAHPGL-MD-11_v1)	Draft
South Africa	SAHPRA	Guideline On Questions And Answers Licensing Of Medical Device Establishments (SAHPGL-MD-07_v3)	Final
South Africa	SAHPRA	Form - Licence Application to Import Distribute or Export Medical Devices	Final
South Africa	SAHPRA	Form - Licence Application Medical Device Manufacture	Final
Switzerland	Swissmedic	New information on submitting vigilance reports for medical devices	Final
Switzerland	Swissmedic	Guidance document - Field Safety Corrective Action (FSCA) economic operators (Version: 3.0)	Final
Switzerland	Swissmedic	Information sheet - FAQ on in vitro diagnostic medical device notifications (Version: 1.4)	Final
Switzerland	Swissmedic	Guidance document - Service Agreement Export Certificates MEP (Version: 1.4)	Final
UK	MHRA	The Innovative Devices Access Pathway (IDAP)	Final
UK	MHRA	Register medical devices to place on the market	Final
US	FDA	Select Updates for the 506J Guidance: 506J Device List and Additional Notifications - Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act - Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	Enforcement Policy for Clinical Electronic Thermometers - Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices - Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions - Guidance for Industry and Food and Drug Administration Staff	Final

Global Medtech Guidance Tracker: November 2023

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