Country	Organization	Document	Status
Australia	TGA	TGA fees and charges proposal 2024-25 (Version 1)	Draft
Australia	TGA	Advertising personalised medical devices	Final
Australia	TGA	Annual reports	Final
Australia	TGA	Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems - Guidance on the transitional arrangements and obligations (Version 1.4)	Final
Australia	TGA	Reclassification of medical devices that administer medicines or biologicals by inhalation - Guidance on the transitional arrangements and obligations (Version 1.4)	Final
Australia	TGA	Reclassification of medical devices that are substances to be introduced into the body or applied to and absorbed by the skin - Guidance on the transitional arrangements and obligations (Version 1.6)	Final
Australia	TGA	Reclassification of spinal implantable medical devices - Guidance on the transitional arrangements and obligations of sponsors and manufacturers (Version 2.6)	Final
Australia	TGA	Reclassification of active medical devices for therapy with a diagnostic function - Guidance on the transitional arrangements and obligations (Version 1.3)	Final
Canada	HC	Regulatory enrolment process (REP)	Final
Canada	HC	Guidance on Medical devices for an urgent public health need	Final
Denmark	DMA	Guidance for the Coordinated Application Process for Combined Studies in Denmark	Final
Denmark	DMA	Language requirement for information about medical devices	Final
Denmark	DMA	Companies' reporting obligation and duty to inform about relationships	Final
EU	EMA	Working instructions for Notified Bodies on the application of Article 54 of Regulation (EU) 2017/745 on medical devices and Article 48 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (EMA/416077/2023)	Final
EU	EC	MDR - language requirements for manufacturers	Final
EU	EC	IVDR – national language requirements for manufacturers	Final
EU	EC	Questions and Answers on in vitro diagnostics and the European Database on Medical Devices (EUDAMED)	Final
EU	MDCG	MDCG 2024-1: Guidance on the vigilance system for CE-marked devices - DSVG 00: Device Specific Vigilance Guidance (DSVG) Template	Final
EU	MDCG	MDCG 2024-1-1: Guidance on the vigilance system for CE-marked devices - DSVG 01: Devices for Cardiac Ablation	Final
EU	MDCG	MDCG 2024-1-2: Guidance on the vigilance system for CE-marked devices - DSVG 02: Coronary Stents and associated delivery systems	Final
EU	MDCG	MDCG 2024-1-3: Guidance on the vigilance system for CE-marked devices - DSVG 03: Cardiac Implantable Electronic Devices (CIEDs)	Final
EU	MDCG	MDCG 2024-1-4: Guidance on the vigilance system for CE-marked devices - DSVG 04: Breast Implants	Final
Hong Kong	DoH	Technical Reference: Artificial Intelligence Medical Devices (AI-MD) - TR-008:2024(E)	Final
India	CDSCO	CDSCO updated list of Laboratories for conducting Performance Evaluation of In - Vitro Diagnostic Medical Device	Final
Malaysia	MDA	General Medical Device – Grouping (MDA/GD/0005), Second Edition	Final
Malaysia	MDA	Importation of Medical Device for Personal Use (MDA/GD/0066), First Edition	Final
Malaysia	MDA	Medical Device Post Market Information Exchange for ASEAN Member States (MDA/GD/0067), First Edition	Final
Philippines	FDA Philippines	Revision in the Process of Application for Certificate of Medical Device Registration (CMDR)/Certificate of Medical Device Notification (CMDN), Initial and Renewal	Final
Saudi Arabia	Saudi FDA	Guidance for Points of Care (POC) Medical Devices Manufacturing (MDS-G009), Version 2	Final
Singapore	HSA	List of Revised Fees for Health Products: Medical Devices	Final
Singapore	HSA	GN-15: Guidance on Medical Device Product Registration (Revision 10)	Final
Singapore	HSA	GN-15: Annex 1 - Letter of Authorisation Template (Revision 10)	Final
Singapore	HSA	GN-15: Annex 2 - Marketing History Declaration Template (Revision 10)	Final
Singapore	HSA	GN-15: Annex 3 - Safety Declaration Template (Revision 10)	Final
South Africa	SAHPRA	Guidelines for users of electronic therapeutic devices emitting ionizing radiation (SAHPGL-RDN-XR-25_v2)	Final
South Africa	SAHPRA	Guideline for import applications of electronic devices emitting ionizing radiation	Final
UK	MHRA	Medical devices: UK approved bodies	Final
UK	MHRA	Notify the MHRA about a clinical investigation for a medical device	Final
UK	MHRA	Export medical devices	Final
UK	MHRA	Register medical devices to place on the market	Final
US	FDA	Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products - Guidance for Industry	Draft
US	FDA	Conducting Remote Regulatory Assessments - Questions and Answers: Draft Guidance for Industry	Draft
US	FDA	Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff	Final

Global Medtech Guidance Tracker: January 2024

More from Guidance

More from Compliance