Country	Organization	Document	Status
Australia	TGA	Off-label use of medical devices: Frequently asked questions	Final
Australia	TGA	Advertising COVID-19 Rapid Antigen Tests	Final
Australia	TGA	Medical device inclusion process – Steps in the process	Final
Australia	TGA	Personalised medical devices (including 3D-printed devices) Regulatory changes for custom-made medical devices (Version 4.0)	Final
Australia	TGA	Frequently asked questions: Regulatory framework for personalised medical devices (Version 4.0)	Final
Australia	TGA	Refinements to the Personalised Medical Device Framework (Version 1.0)	Final
Australia	TGA	Examples of regulated and unregulated software (excluded) software based medical devices (Version 1.2)	Final
Australia	TGA	Medical device patient information leaflets and implant cards (Version 1.4)	Final
Australia	TGA	Regulatory changes for software based medical devices (Version 1.2)	Final
Canada	HC	Notice to industry: Regulatory requirements for UV light-emitting products with COVID-19 claims	Final
Ethiopia	EFDA	Guideline for Classification of In Vitro Diagnostic Medical Devices	Final
Ethiopia	EFDA	Guideline for Classification of medical devices other than IVD medical devices	Final
Ethiopia	EFDA	Guideline for Registration and Import Permit of Medical Device Accessories and Spare Parts	Final
EU	MDCG	MDCG 2021-21 - Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices	Final
EU	MDCG	MDCG 2021-22 - Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746	Final
EU	MDCG	MDCG 2021-23 - Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746	Final
Hong Kong	DoH	Guidance Notes for Listing Class II/III/IV General Medical Devices Guidance Notes: GN-02: 2021(E)	Final
Hong Kong	DoH	Guidance Notes for Listing Class B, C and D In Vitro Diagnostic Medical Devices: GN-06: 2021(E)	Final
Hong Kong	DoH	Application for the Listing of Class II/III/IV General Medical Devices (MD-C2&3&4)	Final
Hong Kong	DoH	Application for the Listing of In-Vitro Diagnostic Medical Devices (IVDMD) (MD-IVD)	Final
India	CDSCO	Classification of medical devices pertaining to Obstetrical and Gynecological under the provision of Medical Devices Rules 2017	Final
India	CDSCO	Classification of medical devices pertaining to Pediatrics and Neonatology under the provision of Medical Devices Rules 2017	Final
India	CDSCO	Classification of medical devices pertaining to Dental under the provision of Medical Devices Rules 2017	Final
India	CDSCO	Classification of medical devices pertaining to Urology under the provision of Medical Devices Rules 2017	Final
India	CDSCO	Classification of medical devices pertaining to Ophthalmology under the provisions of Medical Devices Rules 2017	Final
India	CDSCO	Classification of medical devices pertaining to Radiotherapy under the provisions of Medical Devices Rules 2017	Final
India	CDSCO	Classification of medical devices pertaining to Respiratory under the provisions of Medical Devices Rules 2017	Final
India	CDSCO	Classification of medical devices pertaining to ENT under the provisions of Medical Devices Rules 2017	Final
Pakistan	DRAP	Online Submission of License Applications of Medical Devices	Final
Philippines	FDA Philippines	Reference List of Class A Medical Devices (FDA Circular No.2021-017)	Final
Philippines	FDA Philippines	Addendum to FDA Circular No. 2021-002 Re: Full Implementation of Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements” (FDA Circular No.2021-002-A)	Final
Saudi Arabia	Saudi FDA	Updates on the compliance timeframe for the requirements of medical devices unique device identification (Saudi-DI)	Final
Singapore	HSA	GN-15: Guidance on Medical Device Product Registration (Revision 7. 5)	Final
Singapore	HSA	Frequently asked questions (FAQs) Medical Device UDI System	Final
Singapore	HSA	GN-17: Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT (Revision 1.1)	Final
Singapore	HSA	E-Submission Guide for General Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS (Revision 1.3)	Final
Singapore	HSA	GN-18: Guidance on Preparation of a Product Registration Submission for InVitro Diagnostic Medical Devices using the ASEAN CSDT (Revision 1.1)	Final
Singapore	HSA	E-Submission Guide for In Vitro Diagnostic Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS (Revision 1.2)	Final
Singapore	HSA	GN-02: Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices (Revision 4.4)	Final
Singapore	HSA	Technical Reference-01: Contents of a Product Registration Submission for General Medical Devices using the ASEAN CSDT (Revision 1.3)	Final
Singapore	HSA	Technical Reference-02: Contents of a Product Registration Submission for In Vitro Diagnostic Medical Devices using the ASEAN CSDT (Revision 1.2)	Final
South Africa	SAHPRA	Access to and control of medical devices	Draft
South Africa	SAHPRA	Questions & Answers: Licensing of Medical Device Establishments	Draft
Taiwan	Taiwan FDA	Guidance for Industry to Register Artificial Intelligence/Machine Learning - Based Software as Medical Device (AI_ML-Based SaMD)	Final
UK	MHRA	Export medical devices	Final
US	FDA	Denture Base Resins – Performance Criteria for Safety and Performance Based Pathway: Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Facet Screw Systems – Performance Criteria for Safety and Performance Based Pathway: Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards	Final
US	FDA	FDA Export Certification - Guidance for Industry	Final

Global Medtech Guidance Tracker: August 2021

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