Country	Organization	Document	Status
International	IMDRF	Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews (IMDRF/GRRP WG/N66 PD1)	Draft
International	IMDRF	Principles of In Vitro Diagnostic (IVD) Medical Devices Classification (IMDRF/IVD WG/N64FINAL:2021)	Final
International	IMDRF	IMDRF/AE WG/N43 FINAL:2021 Updated Annexes - Annex A: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Medical Device Problem	Final
International	IMDRF	IMDRF/AE WG/N43 FINAL:2021 Updated Annexes - Annex B: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Type of Investigation	Final
International	IMDRF	IMDRF/AE WG/N43 FINAL:2021 Updated Annexes - Annex C: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Investigation Findings	Final
International	IMDRF	IMDRF/AE WG/N43 FINAL:2021 Updated Annexes - Annex D: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Investigation Conclusion	Final
International	IMDRF	IMDRF/AE WG/N43 FINAL:2021 Updated Annexes - Annex E: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Health Effects - Clinical Signs and Symptoms or Conditions	Final
International	IMDRF	IMDRF/AE WG/N43 FINAL:2021 Updated Annexes - Annex F: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Health Effects - Health Impact	Final
International	IMDRF	IMDRF/AE WG/N43 FINAL:2021 Updated Annexes - Annex G: IMDRF terminologies for categorized Adverse Event Reporting (AER) - Medical Device Component	Final
International	IMDRF	IMDRF terminologies for categorized Adverse Event Reporting (AER) - Change Log	Final
International	IMDRF	Release Notes: IMDRF terminologies for categorized Adverse Event Reporting (AER)	Final
Australia	TGA	Proposed regulatory options for medical devices containing nanomaterials	Draft
Australia	TGA	Regulatory framework for personalised medical devices: Frequently asked questions (Version 1.0)	Final
Australia	TGA	The Therapeutic Goods Administration’s risk management approach to the regulation of therapeutic goods (Version 5.0)	Final
Australia	TGA	Clinical decision support software: Scope and examples (Version 1.0)	Draft
Australia	TGA	Regulatory changes for software based medical devices (Version 1.1)	Draft
Australia	TGA	Fees and charges proposal 2021-22 (Version 1.0)	Draft
Australia	TGA	Proposal for clarifying regulatory requirements for residual claims for disinfectants	Draft
Canada	HC	Second Interim Order respecting the importation and sale of medical devices (COVID-19): Notice to manufacturers, purchasers and users	Final
Canada	HC	Notice to manufacturers, importers and distributors: Research use only for COVID-19 tests	Final
Denmark	DMA	FAQ on the repackaging of face masks for resale	Final
EU	MDCG	MDCG 2021-1: Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional	Final
EU	MDCG	COVID-19 Tests: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19	Final
Ghana	FDA Ghana	Guidelines for Emergency Use Authorization of Medical Products (FDA/GEN/GL-EUA/2021/04)	Final
Saudi Arabia	SFDA	Guidance on Requirements of Shipments Clearance at Ports of Entry (MDS-G21) (Version 4.0)	Final
Singapore	HSA	Medical Device Grouping Tool	Final
Tanzania	TMDA	Extension for payment of annual retention fees for the year 2021 to 28th February with no retention fee penalties	Final
UK	MHRA	Notify the MHRA about a clinical investigation for a medical device	Final
UK	MHRA	Medical devices: information for users and patients	Final
UK	MHRA	Medical devices: legal requirements for specific medical products	Final
UK	MHRA	Regulatory status of equipment being used to help prevent coronavirus (COVID-19)	Final
UK	MHRA	Managing medical devices	Final
UK	MHRA	How tests and testing kits for coronavirus (COVID-19) work	Final
UK	MHRA	Fees payable to the MHRA for 2020 to 2021	Final
UK	MHRA	Assistive technology: definitions, examples and safe use	Final
UK	MHRA	Guidance on applying human factors to medical devices	Final
UK	MHRA	Virtual manufacturing of medical devices	Final
US	FDA	Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests - Guidance for Test Developers and Food and Drug Administration Staff	Final

Global Medtech Guidance Tracker: February 2021

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