Country	Organization	Documents	Status
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 1.2)	Final
Australia	TGA	Reclassification of medical devices that administer medicines or biologicals by inhalation - Guidance on the transitional arrangements and obligations (Version 1.2)	Final
Australia	TGA	Reclassification of spinal implantable medical devices - Guidance on the transitional arrangements and obligations of sponsors and manufacturers (Version 2.4)	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 1.3)	Final
Australia	TGA	Reclassification of active implantable medical devices (AIMD) - Guidance on the transitional arrangements and obligations (Version 1.3)	Final
Australia	TGA	Reclassification of active medical devices for therapy with a diagnostic function - Guidance on the transitional arrangements and obligations (Version 1.1)	Final
Australia	TGA	Form: Sponsor notification for medical devices transitioning from the EU MDD to the EU MDR	Draft
Canada	HC	Draft guidance document: Terms and conditions for medical devices	Draft
Canada	HC	Extension of interim enforcement approach for federal, provincial and territorial COVID-19 testing initiatives	Final
Denmark	DMA	Certificates of Free Sale to Danish manufacturers of medical devices	Final
Denmark	DMA	Changes in company information or information about marketed devices	Final
Denmark	DMA	Deregistration of medical devices	Final
EU	EC	Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications in accordance with Regulation (EU) 2017/745	Final
EU	EC	Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745	Final
EU	MDCG	Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (Version 2)	Final
EU	MDCG	MDCG 2022-20 - Substantial modification of performance study under Regulation (EU) 2017/746	Final
EU	MDCG	MDCG 2020-19 - Performance study application/notification documents under Regulation (EU) 2017/746	Final
EU	MDCG	MDCG 2022-4 Rev.1 - Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD	Final
EU	MDCG	MDCG 2022-17 - MDCG position paper on ‘hybrid audits’	Final
EU	MDCG	MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 (MDR)	Final
EU	MDCG	MDCG 2022-18 - MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate	Final
EU	TEAM-NB	The designation of notified bodies under the upcoming Artificial Intelligence Act (Version 1)	Final
EU	TEAM-NB	Team NB Position in Response to MDCG 2022-14 Item Number 17 – ‘Certificates under Conditions’ (Version 1)	Final
Ghana	Ghana FDA	Guideline For Registration Of Used And Refurbished Medical Equipment	Final
Hong Kong	DoH	Post-Market Surveillance Report Form (MD108)	Final
Hong Kong	DoH	Continuance of trial schemes for accepting 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	Final
India	CDSCO	Applicant User Manual For Form MD-41 (Version: 1.0)	Final
Ireland	HPRA	Guide to Fees for Human Products (FIN-G0002-30) [Track version]	Final
Ireland	HPRA	Fee Application Form for Human Products	Final
Ireland	HPRA	Guide to Applications for Certificates of Free Sale for Medical Devices (AUT-G0026-12)	Final
Ireland	HPRA	Application for certificates for free sale (IVDD medical devices, up classified and legacy devices)	Final
Malaysia	MDA	Requirements for application of Certificate of Free Sale (CFS), Manufacturing Certificate (MC) and Certificate of Free Sale for Export Only (CFS EO) medical devices	Draft
Netherlands	MEB	Changes to fees for human medicinal products and devices as of 1 January 2023	Final
Saudi Arabia	Saudi FDA	Guidance for Requirements of blood glucose metering devices and strips for home use - Recognized Standards (MDS – G006), Version 1.1	Final
Saudi Arabia	Saudi FDA	Guidance for Requirements of sterile single-use hypodermic syringes - Recognized Standards (MDS – G005), Version 1.1	Final
Saudi Arabia	Saudi FDA	Guidance for Requirements of Surgical and Medical Examination Gloves - Recognized Standards (MDS – G004), Version 1.1	Final
Saudi Arabia	Saudi FDA	Guidance on Medical Devices Classification (MDS – G008), Version 2	Final
Switzerland	Swissmedic	Information sheet - FAQ Notifications	Final
Switzerland	Swissmedic	Information sheet - 3D printers medical devices	Final
Switzerland	Swissmedic	Information sheet - Swiss Single Registration Number: CHRN	Final
Switzerland	Swissmedic	Frequently Asked Questions on medical devices: Update of the section "Products without medical purpose"	Final
Switzerland	Swissmedic	Clarification of terminology for combination products (medicinal products with a medical device component)	Final
UK	MHRA	Exceptional use of non-UKCA marked medical devices	Final
UK	MHRA	Medical devices: UK approved bodies	Final
UK	MHRA	Innovation Accelerator	Final
UK	MHRA	Register medical devices to place on the market	Final
US	FDA	Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers - Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection - Draft Guidance for Industry	Draft
US	FDA	Content of Human Factors Information in Medical Device Marketing Submissions - Draft Guidance for Industry and Food and Drug Administration Staff	Draft

Global Medtech Guidance Tracker: December 2022

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