Country	Organization	Document	Status
International	MDSAP	Further Extension of Temporary Extraordinary Measures related to MDSAP audits during Covid-19 quarantine orders and travel restrictions – alternative audit arrangements	Final
International	WHO	Technical specifications for health facility based medical oxygen system products	Draft
Australia	TGA	Review of first-in-human high-risk implantable or cardiac invasive medical device clinical trials	Draft
Australia	TGA	Investigator’s brochures for medical device clinical trials	Draft
Australia	TGA	IVD companion diagnostics (CDx): Guidance on Australian regulatory requirements (Version 1.3)	Draft
Australia	TGA	Consultation: Proposed clarification of how Clinical Decision Support System software is regulated (Version 1.0)	Draft
Australia	TGA	Supporting documentation for inclusion of a medical device	Final
Australia	TGA	Uniform Recall Procedure for Therapeutic Goods (URPTG), Version 2.4	Final
Australia	TGA	Recall action templates	Final
Australia	TGA	Authorised Prescriber Scheme - Guidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors (Version 5.3)	Final
Australia	TGA	Authorised Prescriber - Special Access Scheme & Authorised Prescriber Scheme Online System guidance (Version 1.7)	Final
Australia	TGA	Special Access Scheme (SAS) - Special Access Scheme & Authorised Prescriber Scheme Online System guidance (Version 1.9)	Final
Australia	TGA	Special Access Scheme (SAS) - Guidance for health practitioners accessing unapproved therapeutic goods (Version 2.0)	Final
Canada	HC	The Regulatory Enrolment Process (REP): Medical Devices [Available on request from Health Canada]	Final
EU	European Commission	MDR - language requirements for manufacturers (Rev. 1)	Final
EU	European Commission	IVDR – national language requirements for manufacturers (Rev. 1)	Final
EU	MDCG	MDCG 2024-3: Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices	Final
EU	MDCG	MDCG 2024-3 Appendix A: Clinical Investigation Plan Synopsis Template	Final
Final	Fimea	Marketing of medical devices	Final
Hong Kong	DoH	New Medical Device Information System	Final
Hong Kong	DoH	Definitions and Abbreviations for the Medical Device Administrative Control System (GN-00:2024(E))	Final
Hong Kong	DoH	Overview of the Medical Device Administrative Control System (GN-01:2024-1(E))	Final
Hong Kong	DoH	Guidance Notes for Listing Class II/III/IV General Medical Devices (GN-02:2024-1(E))	Final
Hong Kong	DoH	Conformity Assessment Framework and Conformity Assessment Bodies (GN-04:2024(E))	Final
Hong Kong	DoH	Guidance Notes for Listing Class B, C and D In Vitro Diagnostic Medical Devices (GN-06:2024-1(E))	Final
Hong Kong	DoH	Form - Application for the Listing of Class II/III/IV General Medical Devices (MD101)	Final
Hong Kong	DoH	Form - Application for the Listing of In Vitro Diagnostic Medical Devices (IVDMD) (MD102)	Final
Hong Kong	DoH	Code of Practice for Listed Distributors of Medical Devices (COP-05:2024(E))	Final
India	DoP	Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024	Final
India	CDSCO	Submission of online applications of PSURs for marketing authorization of Medical Devices/In Vitro Devices	Final
Malaysia	MDA	Faster approval for establishment license application	Final
Netherlands	CCMO	Pilot Scientific Advice CCMO	Final
Netherlands	CCMO	Application form Pilot Scientific Advice CCMO	Final
Philippines	FDA Philippines	Extension of the Regulatory Flexibility for Class B, C and D Medical Devices that are Not Included in the List of Registrable Medical Devices Based on FDA Circular No. 2020-001-A entitled “Amendment to Annex A of FDA Circular No. 2020-001 re: Initial Implementation of Administrative Order No. 2018-0002 “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements””	Final
Philippines	FDA Philippines	Extension of the Transitory Provision of FDA Circular No. 2021-021 Entitled “Guidelines on the Licensing of Retailers of Medical Devices in the Philippines” for FDA Licensed Manufacturers, Traders or Distributor (Importers, Exporters and/or Wholesalers) of Medical Devices that Also Sell or Intend to Sell Medical Devices to the General Public	Final
Philippines	FDA Philippines	Full Implementation of FDA Circular No. 2021-021 Entitled “Guidelines on the Licensing of Retailers of Medical Devices in the Philippines”	Final
Saudi Arabia	Saudi FDA	Guidance on the development of IVDs for in-house use (MDS – G022), Version 1.0	Final
Saudi Arabia	Saudi FDA	Guidance for Surgical Sutures (MDS – G021), Version1.0	Final
Singapore	HSA	GN-15: Guidance on Medical Device Product Registration (Revision 11)	Final
Singapore	HSA	GN-15-R11: Annex 1 Letter of Authorisation Template	Final
Singapore	HSA	GN-15-R11: Annex 2 Marketing History Declaration Template	Final
Singapore	HSA	GN-15-R11: Annex 3 Safety Declaration Template	Final
Singapore	HSA	GL-04-R3: Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach (Revision 3)	Final
Singapore	HSA	GN-17: Guidance on Preparation of a Product Registration Submission for GMD using the ASEAN CSDT (Revision 3)	Final
Singapore	HSA	E-Submission Guide for General Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS (Revision 3)	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-18: Guidance on Preparation of a Product Registration Submission for IVD MD using the ASEAN CSDT (Revision 3)	Final
Singapore	HSA	E-Submission Guide for IVD MD for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS (Revision 3)	Final
Singapore	HSA	Technical Reference TR-01 Contents of a Product Registration Submission for GMD using the ASEAN CSDT (Revision 3)	Final
Singapore	HSA	Technical Reference TR-02 Contents of a Product Registration Submission for IVD MD using the ASEAN CSDT (Revision 3)	Final
South Africa	SAHPRA	Guideline for Classification of Medical Devices and IVDs (SAHPGL-MD-04), Version 4	Final
South Africa	SAHPRA	Collection of Outstanding Retention Fees	Final
UK	MHRA	Medical devices: UK approved bodies	Final
UK	MHRA	Regulation of devices in Northern Ireland	Final
UK	MHRA	Notify the MHRA about a clinical investigation for a medical device	Final
US	FDA	Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling - Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act - Draft Guidance for Industry and Food and Drug Administration Staff	Draft

Global Medtech Guidance Tracker: March 2024

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