Country	Organization	Document	Status
Australia	TGA	Proposed application audit framework for medical device (Version 2.0)	Draft
Australia	TGA	Varying entries in the ARTG - Medical devices and IVD medical devices (Version 3.0)	Final
Australia	TGA	Form - Request to reinstate an entry on the Australian Register of Therapeutic Goods (ARTG)	Final
Australia	TGA	Auditing of medical device, including IVD medical device, applications	Final
Australia	TGA	Guidance on the regulation of listed disinfectants in Australia (Version 2.1)	Final
Denmark	DMA	Certificates of Free Sale to Danish manufacturers of medical devices	Final
EU	EC	Extension of the MDR Transitional Period and Removal of the ‘Sell Off’ Periods - Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices (Rev. 1)	Final
EU	EMA	Questions & Answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies (EMA/619893/2022)	Final
EU	EMA	Template or Form: Letter of intent for the submission of a consultation to the European Medicines Agency by a notified body on a companion diagnostic in accordance with Regulation (EU) 2017/746 (EMA/781233/2021)	Final
EU	EMA	Questions & Answers on the consultation procedure to the European Medicines Agency by notified bodies on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device (EMA/144066/2021 Rev. 2)	Final
EU	EMA	Methodology for the establishment of the “public health emergency critical medical devices list”	Final
Malta	MMA	Notice - Organisation Registration relevant to Medical Device Regulatory Sciences in Malta	Final
Malta	MMA	Application Form for Certificates of Free Sale (CFS) for Medical Devices (MT-MDF01)	Final
Malta	MMA	Application Form for Organisation Registration in relation to Medical Devices (MT-MDF02)	Final
Malta	MMA	Application Form for Medical Device Registration to place Medical Devices on the EU Market (MT-MDF03)	Final
Malta	MMA	Request Form for the Use of a Non-CE Marked Medical Device in Malta (MT-MDF04)	Final
Malta	MMA	Application Form to be submitted when applying for Designation as a Notified Body under the Medical Devices Regulation (EU) 2017/745 (MDR) / In-Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) (MT-MDF06)	Final
Malta	MMA	Application for Designated Premises to be approved for the performing of Point-of-Care Covid-19 Tests (MT-MDF07)	Final
Malta	MMA	Application Form for Notification of Point-of-Care Covid-19 Test or Device for Self-Testing for Covid-19 to be placed on the Local Market (MT-MDF10)	Final
Malta	MMA	Request Form for Advice on Making Available Medical Device/In-Vitro Diagnostic Products in Malta (MT-MDF19)	Final
Malta	MMA	Request Form for Medical Device/In-Vitro Diagnostic Confirmation of Risk Classification (MT-MDF20)	Final
Philippines	FDA Philippines	Rules and Regulations for Establishment and Operation of Medical 6 Magnetic Resonance Imaging (MRI) Facilities in the Philippines	Draft
Singapore	HSA	GN-15: Guidance on Medical Device Product Registration (Revision 9)	Final
Singapore	HSA	GN-15-R9 Annex 1: Letter of Authorisation Template	Final
Singapore	HSA	GN-15-R9 Annex 2: Marketing History Declaration Template	Final
Singapore	HSA	GN-15-R9 Annex 3: Safety Declaration Template	Final
Singapore	HSA	GN-17: Guidance on Preparation of a Product Registration Submission for GMD using the ASEAN CSDT (Revision 2)	Final
Singapore	HSA	E-Submission Guide for General Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS (Revision 2)	Final
Singapore	HSA	GN-18: Guidance on Preparation of a Product Registration Submission for IVD MD using the ASEAN CSDT (Revision 2)	Final
Singapore	HSA	E-Submission Guide for In Vitro Diagnostic Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS (Revision 2)	Final
Singapore	HSA	Annex 2 to GN 17 (Guidance on the Common Submission Dossier Template for General Medical Devices) and GN 18 (Guidance on the Common Submission Dossier Template for In Vitro Diagnostic Medical Devices): List of Configurations of Medical Device to be Registered	Final
Singapore	HSA	GN-14: Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices (Revision 3)	Final
Singapore	HSA	GN-02: Guidance on Licensing of Manufacturers, Importers and Wholesalers of MD (Revision 5)	Final
Singapore	HSA	GN-02-R5 Annex 1: Declaration for Exemption from GDPMDS Certification	Final
Singapore	HSA	GN-02-R5 Annex 5: Declaration of Conformity to a Quality Management System (QMS)	Final
Singapore	HSA	GN-02-R5 Annex 6: Declaration of Non-Dealing of Class A Medical Devices	Final
Singapore	HSA	TR-01: Contents of a Product Registration Submission for GMD using the ASEAN CSDT (Revision 2)	Final
Singapore	HSA	TR-02: Contents of a Product Registration Submission for In Vitro Diagnostic Medical Devices using the ASEAN CSDT (Revision 2)	Final
South Korea	MFDS	Guidance on Clinical Trials Design of Artificial Intelligence(AI)-based Medical Devices (posted online July 2023)	Final
South Korea	MFDS	Guidance on the Review and Approval of Artificial Intelligence(AI)-based Medical Devices (posted online July 2023)	Final
Tanzania	TMDA	Guidelines for handling unfit medical devices and diagnostics (First Edition)	Draft
UK	MHRA	Implementation of medical devices future regime	Final
UK	MHRA	Regulating medical devices in the UK	Final
UK	MHRA	Register medical devices to place on the market	Final
UK	MHRA	How tests and testing kits for coronavirus (COVID-19) work	Final
UK	MHRA	In vitro diagnostic medical devices: guidance on legislation	Final
UK	MHRA	Borderline products: how to tell if your product is a medical device and which risk class applies	Final
US	FDA	Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder - Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	Qualification of Medical Device Development Tools - Guidance for Industry, Tool Developers, and Food and Drug Administration Staff	Final

Global Medtech Guidance Tracker: July 2023

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