Country	Organization	Document	Status
Australia	TGA	TGA quality management system audits and certification - Guidance for manufacturers of medical devices (Version 2.0)	Final
Australia	TGA	How to submit a custom-made medical device/patient-matched medical device notification - Step-by-step guide (Version 2.0)	Final
Australia	TGA	Refinements to the Personalised Medical Device Framework (Version 2.0)	Final
Australia	TGA	Personalised medical devices (including 3D-printed devices) - Regulatory changes for custom-made medical devices (Version 6.0)	Final
Australia	TGA	Guidance on boundary and combination products - Medicines, medical devices, and biologicals (Version 2.0)	Final
Canada	HC	Updates to the medical device establishment licence application (FRM-0292) and instructions	Final
Canada	HC	Medical device establishment licence application form (FRM-0292)	Final
Denmark	DMA	Fees for performance studies of in vitro diagnostic medical devices	Final
Denmark	DMA	Fees for clinical investigation of medical devices	Final
Denmark	DMA	Application for clinical investigation of medical devices	Final
Denmark	DMA	Application for the authorisation for performance studies of in vitro diagnostic medical devices	Final
EU	EC	Commission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices	Final
EU	EMA	Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) (30 November 2023 Rev. 3) [Track version]	Final
EU	MDCG	MDCG 2023-6: Guidance on demonstration of equivalence for Annex XVI products	Final
EU	MDCG	MDCG 2023-5: Guidance on qualification and classification of Annex XVI products	Final
EU	MDCG	MDCG 2023-7: Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence	Final
EU	MDCG	MDCG 2021-6 Rev. 1: Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation	Final
EU	MDCG	MDCG 2021-27 Rev.1: Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746	Final
EU	MDCG	MDCG 2019-07 Rev.1: Guidance on Article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)	Final
EU	TEAM-NB	Position paper - Medical Device Lifetime	Final
Finland	Fimea	Medical device operator: Check the registered information for the supervision fee to be collected in 2024	Final
Hong Kong	DoH	Announcement of the acceptance of marketing approvals obtained from the National Medical Products Administration and the Ministry of Food and Drug Safety of Korea under the Medical Device Administrative Control System (MDACS)	Final
Hong Kong	DoH	Overview of the Medical Device Administrative Control System - GN-01:2024(E)	Final
Hong Kong	DoH	Guidance Notes for Listing Class II, III & IV General Medical Devices - GN-02:2024(E)	Final
Hong Kong	DoH	Guidance Notes for Listing Class B, C and D In Vitro Diagnostic (IVD) Medical Devices - GN-06:2024(E)	Final
Hong Kong	DoH	Technical Reference: Software Medical Devices and Cybersecurity - TR-007:2023(E)	Final
Hong Kong	DoH	Technical Reference: Classification of In Vitro Diagnostic Medical Devices (IVDMDs) - TR-006:2023(E)	Final
Hong Kong	DoH	Form - Medical Device Administrative Control System: Application for the Listing of Class II/III/IV General Medical Devices	Final
Hong Kong	DoH	Form - Medical Device Administrative Control System Application for the Listing of In Vitro Diagnostic Medical Devices (IVDMD)	Final
Hong Kong	DoH	Form - Change Application Form for Listed Medical Devices	Final
India	CDSCO	Launching of National Single Window System (NSWS) Portal	Final
Ireland	HPRA	Guide for Health Institutions that Manufacture and Use In-house in vitro Diagnostic Medical Devices (IVD) in Ireland	Draft
Ireland	HPRA	Guide to Fees for Human Products (FIN-G0002-33) [Track version]	Final
Ireland	HPRA	Form - Fee Application Form for Human Products	Final
Malaysia	MDA	Harmonised Borderline Products in ASEAN (MDA/GD/0063), Second Edition	Final
Malaysia	MDA	Harmonised Classification Of Medical Devices in ASEAN (MDA/GD/0062), Second Edition	Final
Philippines	FDA Philippines	Guidelines on the Recall of Health Products Regulated by the Food and Drug Administration	Draft
Philippines	FDA Philippines	Submission of Position Paper/Comments on the Draft Administrative Order entitled “Implementing Guidelines on the Schedule of Fees and Charges of the Food and Drug Administration for Licensing, Registration and Other Authorizations and Regulatory Services Repealing Administrative Order No. 50s. 2001, “Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food and Drugs” and its Amendments	Draft
Saudi Arabia	Saudi FDA	Guidance on Medical Devices Samples Collection (MDS – G013)	Final
Switzerland	Swissmedic	Information sheet - Clinical investigations with medical devices (Version 4.3)	Final
Switzerland	Swissmedic	Information sheet - Performance studies with IVD (Version 3.4)	Final
Switzerland	Swissmedic	Information sheet - Derogation MEP (Version 4.0)	Final
Switzerland	Swissmedic	Information sheet - Service agreement for Swiss Single Registration Number (CHRN) (Version 2.3)	Final
Switzerland	Swissmedic	Information sheet - Swiss Single Registration Number – CHRN (Version 3.3)	Final
Switzerland	Swissmedic	FAQs: Updated section on Devices manufactured and used in healthcare institutions	Final
Switzerland	Swissmedic	Regulations on disinfectants in Switzerland - Information sheet (Version 1)	Final
UK	MHRA	Make a payment to MHRA	Final
UK	MHRA	Notify the MHRA about a clinical investigation for a medical device	Final
US	FDA	510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review: Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations	Draft
US	FDA	Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Digital Health Technologies for Remote Data Acquisition in Clinical Investigations - Guidance for Industry, Investigators, and Other Stakeholders	Final
US	FDA	Data Standards Catalog (Version 10.2)	Final

Global Medtech Guidance Tracker: December 2023

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