Country	Organization	Document	Status
International	MDSAP	Further Extension of Temporary Extraordinary Measures related to MDSAP audits during covid-19 quarantine orders and travel restrictions	Final
Australia	TGA	Guidance for requesting reconsideration of an initial decision (Version 2.4)	Final
Australia	TGA	Medical devices Essential Principles checklist	Final
Australia	TGA	Medical device patient information leaflets and implant cards	Final
Australia	TGA	Guidance on applying the Advertising Code rules	Final
Belgium	FAMHP	New system for financing the surveillance of the medical devices market	Final
Canada	HC	Proposed changes to the Medical Devices Regulations to address future public health emergencies: Notice	Final
Denmark	DMA	FAQ on AI in medical devices	Final
Denmark	DMA	Products without an intended medical purpose	Final
Denmark	DMA	Notified bodies	Final
EU	EC	Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periods	Final
India	CDSCO	List of Notified Bodies registered with CDSCO under MDR 2017	Final
India	CDSCO	List of the certified Medical Devices Testing Laboratory (MDTL) under MDR 2017	Final
India	ICMR	Ethical guidelines for application of Artificial Intelligence in Biomedical Research and Healthcare 2023	Final
Ireland	HPRA	Application for a Clinical Investigation of Non-CE Marked Medical Devices (Article 62 MDR)	Final
Japan	PMDA	Partial Revision of the “Points to Consider for Approval Applications for Home Medical Devices to Detect Signs of Diseases and to Encourage Medical Consultation” (English translation of notice issued in December 2022)	Final
Malaysia	MDA	Withdrawal of medical device registration (new and re-register) and change of notification application	Final
Malaysia	MDA	Classification of Rehabilitation, Physiotherapy and Speech Therapy Device (MDA/GD/0061), Second Edition	Final
Philippines	FDA Philippines	Guidelines on 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
Saudi Arabia	Saudi FDA	Guidance on Manufacturing Paths of Medical Devices and Supplies (MDS – G011), Version 1.0	Final
Saudi Arabia	Saudi FDA	Guidance on MDMA – Significant and Non-Significant Changes (MDS – G012), Version 1.0	Final
Singapore	HSA	GN-21: Guidance on Change Notification for Registered Medical Devices (Revision 5)	Final
South Africa	SAHPRA	ISO 13458 Conformity Assessment Body	Draft
South Africa	SAHPRA	Guideline For Import Applications Of Electronic Devices Emitting Ionizing Radiation	Draft
South Africa	SAHPRA	Guidelines For Users Of Therapeutic Devices Emitting Ionizing Radiation	Draft
South Africa	SAHPRA	Guideline for Classification of Medical Devices and IVDs (SAHPGL-MD-04)	Final
South Africa	SAHPRA	Guideline on Medical Device Quality Manual (SAHPGL-MD-05)	Final
South Africa	SAHPRA	Guideline for a License to Manufacture, Import, Export, or Distribute Medical Devices and IVDs (SAHPGL-MD-06)	Final
Switzerland	Swissmedic	MDR/IVDR amendment: Equivalence with EU Regulation on Medical Devices ensured	Final
UK	MHRA	Extension of CE certificates	Final
UK	MHRA	Register medical devices to place on the market	Final
UK	MHRA	Export medical devices	Final
UK	MHRA	Crafting an intended purpose in the context of software as a medical device (SaMD)	Final
UK	MHRA	MHRA fees	Final
US	FDA	Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions - Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations - Questions and Answers: Guidance for Industry	Draft
US	FDA	Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act - Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	General Considerations for Animal Studies Intended to Evaluate Medical Devices - Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff	Final
US	FDA	Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) - Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff	Final
US	FDA	Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	Enforcement Policy for Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff	Final

Global Medtech Guidance Tracker: March 2023

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