Country	Organization	Document	Status
International	WHO	Good practices of national regulatory authorities in implementing the collaborative registration procedures for medical products (QAS/24.956)	Draft
International	MDSAP	Extension of Remote and Hybrid Auditing Pilot	Final
International	GHWP	UDI Data Elements (GHWP/WG9/PD002:2024)	Draft
International	GHWP	Creation and Placement of Unique Device Identifier (GHWP/WG9/PD001:2024)	Draft
International	GHWP	Guidelines for Adverse Event Reporting of Percutaneous Coronary Intervention (PCI) devices for the Medical Device Manufacturer or its Authorized Representative (GHWP/WG4/PD002:2024)	Draft
International	GHWP	Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative (GHWP/WG4/PD001:2024)	Draft
Australia	TGA	Regulatory changes for medical devices containing medicinal substances or materials of animal, microbial or recombinant origin - Guidance on the new regulatory requirements and transition arrangements (Version 1.0)	Draft
Australia	TGA	Medical Devices – Essential Principles for Safety and Performance - Part 2: Proposed alignment with the European Regulations (Version 1.0)	Draft
Australia	TGA	Medical Devices – Essential Principles for Safety and Performance - Attachment 1: Proposals to align the Australian Essential Principles with the European General Safety and Performance Requirements (Version 1.0)	Draft
Australia	TGA	CTA scheme forms	Final
Australia	TGA	Withdraw your ARTG application	Final
Australia	TGA	Medical devices Essential Principles checklist (Version 1.2)	Final
Australia	TGA	Should your product be in the ARTG	Final
Australia	TGA	Medical device conformity assessment application	Final
Australia	TGA	Varying entries in the ARTG - Medical devices and IVD medical devices (Version 5.0)	Final
Egypt	EDA	Guideline for Good Regulatory Oversight of Clinical Trials by Egyptian Drug Authority (Version 3)	Draft
EU	EC	Amending Implementing Regulation (EU) 2022/1107 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council	Draft
EU	EC	Annex I to Amending Implementing Regulation (EU) 2022/1107 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council	Draft
EU	EC	Commission Implementing Decision (EU) 2024/2120 of 30 July 2024 renewing the designation of issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices	Final
EU	EC	Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices	Final
EU	EC	Notified Body list of standard fees	Final
EU	TEAM-NB	Team-NB Template – Notified body Confirmation of the status of a formal application, written agreement, and appropriate surveillance in the framework of Regulation EU 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices (Version 2)	Final
Hong Kong	DoH	Technical Reference: Classification of General Medical Devices (TR-003:2024(E)), Version 2	Final
Hong Kong	DoH	Overview of the Medical Device Administrative Control System (GN-01:2024-3(E))	Final
Hong Kong	DoH	Guidance Notes for Listing Class II/III/IV General Medical Devices (GN-02:2024-3(E))	Final
Hong Kong	DoH	Conformity Assessment Framework and Conformity Assessment Bodies (GN-04:2024-1(E))	Final
Hong Kong	DoH	Guidance Notes for Listing Class B, C and D In Vitro Diagnostic Medical Devices (GN-06:2024-3(E))	Final
Hong Kong	DoH	Guidance Notes for Listing of Importers of Medical Devices (GN-07:2024-2(E))	Final
Hong Kong	DoH	Guidance Notes for Listing of Local Manufacturers of Medical Devices (GN-08:2024-2(E))	Final
Hong Kong	DoH	Guidance Notes for Listing of Distributors of Medical Devices (GN-09:2024-2(E))	Final
Hong Kong	DoH	Code of Practice for Local Responsible Persons (COP-01:2024-1(E))	Final
Hong Kong	DoH	Code of Practice for Conformity Assessment Bodies (COP-02:2024-1(E))	Final
Hong Kong	DoH	Code of Practice for Listed Local Manufacturers of Medical Devices (COP-03:2024-1(E))	Final
Hong Kong	DoH	Code of Practice for Listed Importers of Medical Devices (COP-04:2024-1(E))	Final
Hong Kong	DoH	Code of Practice for Listed Distributors of Medical Devices (COP-05:2024(E))	Final
Malta	MMA	Guidance on fees in relation to Medical Devices (GL-MDF07/10)	Final
Malta	MMA	Guidance for Notification for Modification of Clinical Investigations under the Regulation (EU) 2017/745 (GL-MDF15/02)	Final
Malta	MMA	Guidance for Notification for Modification of Performance Studies under the Regulation (EU) 2017/746 (GL-MDF16/01)	Final
Malta	MMA	Guidance for Application for Pre-submission Meeting Request for Clinical Investigations/Performance Studies (GL-MDF17/02)	Final
Netherlands	CCMO	Sample ABR form Research Portal	Final
Netherlands	CCMO	Briefing Book information - Pilot Scientific Advice CCMO	Final
New Zealand	Medsafe	Clinical Trial Safety Monitoring and Reporting for Investigational Products (Medicines and Medical Devices) (Edition 1)	Draft
Nigeria	NAFDAC	Guidelines for Registration of Software as a Medical Device (SaMD) in Nigeria	Final
Nigeria	NAFDAC	Guidelines for Renewal of Certificate of Product Registration for (Imported and Locally Manufactured) Medical Devices in Nigeria	Final
Nigeria	NAFDAC	Guidelines for Registration of Medical Devices (Imported and Locally Manufactured) in Nigeria	Final
Philippines	FDA Philippines	Pilot Implementation of the Food and Drug Administration (FDA) eServices Portal System for the Initial Application of a Certificate of Medical Device Notification (CMDN) within the National Capital Region (NCR)	Final
Singapore	HSA	Guidance on Change Management Program (CMP) for SaMD	Draft
Switzerland	Swissmedic	Information sheet - Combined studies (Version 1.0)	Final
Switzerland	Swissmedic	Information sheet - Clinical investigations with medical devices (Version 6.0)	Final
Switzerland	Swissmedic	Information sheet - Performance studies with IVD (Version: 5.0)	Final
Switzerland	Swissmedic	Form - Authorisation combined study IMP and MD	Final
Switzerland	Swissmedic	Form - Authorisation combined study IMP and IVD	Final
Switzerland	Swissmedic	Form - Combined study MP/ATMP and MD/IVD Amendments, notifications, reports	Final
Switzerland	Swissmedic	Form - Notification of safety measures combined studies	Final
Switzerland	Swissmedic	Form - Application Confidentiality Restrictions	Final
Switzerland	Swissmedic	Form - Application for fee reduction	Final
Switzerland	Swissmedic	EU IVDR amendment: Equivalence with EU Regulation on Medical Devices ensured	Final
Switzerland	Swissmedic	swissdamed “Actors” module now available	Final
Switzerland	Swissmedic	Handbook - swissdamed User Guide Actors (Version1.2)	Final
Switzerland	Swissmedic	Guidance document - swissdamed Privacy Notice and Terms of Use (Version 1.0)	Final
Switzerland	Swissmedic	Guidance document - swissdamed Service Agreement (Version 1.0)	Final
Tanzania	TMDA	Protocol for Performance Laboratory Evaluation of Malaria Plasmodium Falciparum (PF) and Malaria PF/Pan Antigen Rapid Diagnostic Tests, First edition (Posted online August 2024)	Final
Tanzania	TMDA	Protocol for Performance Laboratory Evaluation of HIV Serology Assays, First Edition (Posted online August 2024)	Final
Tanzania	TMDA	Protocol for Performance Laboratory Evaluation of Combined HIV and Syphilis Serology Assays, First Edition (Posted online August 2024)	Final
Tanzania	TMDA	Protocol for Performance Laboratory Evaluation of Hepatitis C Serology Assays, First Edition (Posted online August 2024)	Final
Tanzania	TMDA	Protocol for Laboratory Performance Evaluation of Hepatitis B Surface Antigen, First Edition (Posted online August 2024)	Final
Tanzania	TMDA	Protocol for Laboratory Performance Evaluation of SARS-CoV-2 Antigen Assays, First Edition (Posted online August 2024)	Final
Tanzania	TMDA	Guidelines for Conducting Performance Evaluation Of In-Vitro Diagnostic Devices Submitted for Marketing Authorization (Posted online August 2024)	Final
Tanzania	TMDA	Guidelines on Good Review Practices for Regulation of Medical Devices (Posted online August 2024)	Final
UK	MHRA	MHRA consultation on statutory fees - Proposals on ongoing cost recovery	Draft
UK	MHRA	Notify MHRA about a clinical investigation for a medical device	Final
UK	MHRA	Export medical devices	Final
UK	MHRA	Register medical devices to place on the market	Final
US	FDA	Predetermined Change Control Plans for Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers - Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide - Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	Electronic Submission Template for Medical Device De Novo Requests - Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act - Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	Acceptable Media for Electronic Product User Manuals - Guidance for Industry and Food and Drug Administration Staff	Final

Global Medtech Guidance Tracker: August 2024

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