Country	Organization	Document	Status
International	WHO	Technical Specifications Series (17) - In vitro diagnostic (IVD) medical devices used for the qualitative detection of Mycobacterium tuberculosis complex DNA and mutations associated with drug-resistant tuberculosis	Final
Australia	TGA	Consultation on proposed regulatory changes for clinical trials of medical devices	Draft
Australia	TGA	UDI consultation paper 3: Detailed considerations for implementing the proposed Australian medical device UDI Regulatory Framework	Draft
Australia	TGA	Frequently asked questions – Regulatory framework for personalised medical devices (Version 5.0)	Final
Australia	TGA	Personalised medical devices (including 3D-printed devices) – Regulatory changes for custom-made medical devices (Version 5.1)	Final
Australia	TGA	Application audit (technical file review) of IVD medical device applications (Version 1.1)	Final
Australia	TGA	Exemption for Certain Clinical Decision Support Software – Guidance on the exemption criteria (Version 1.0)	Final
Australia	TGA	Regulation of software based medical devices	Final
Australia	TGA	Australian regulatory guidelines for medical devices (ARGMD)	Final
Australia	TGA	Form - Application for priority applicant determination - medical devices	Final
Australia	TGA	Form - Organisation details Sponsor, Manufacturer and Agent	Final
Canada	HC	Health Canada will continue to issue electronic manufacturer’s certificate to export	Final
EU	MDCG	MDCG 2022-13 – Designation, re-assessment and notification of conformity assessment bodies and notified bodies	Final
EU	MDCG	MDCG 2022-14 – MDCG Position Paper: Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs	Final
EU	EC	Medical devices - reclassification of products without an intended medical purpose	Draft
EU	EC	Consolidated version of the frequently asked questions concerning sanctions adopted following Russia’s military aggression against Ukraine and Belarus' involvement in it: Medicines and medical devices	Final
EU	TEAM-NB/NBCG-Med	Notified body approach for the Technical Documentation assessment approach of multiplex in-vitro diagnostic devices	Final
Finland	Fimea	Supervision fees for medical devices will be sent to operators in late August and early September	Final
Hong Kong	DoH	Form - Trial Scheme for acceptance of marketing approval obtained from the Ministry of Food and Drug Safety - Application Form for the Listing of Class II/III/IV General Medical Devices	Final
Hong Kong	DoH	Form - Trial Scheme for acceptance of marketing approval obtained from the National Medical Products Administration - Application Form for the Listing of In-Vitro Diagnostic Medical Devices (IVDMD)	Final
India	CDSCO	List of Notified Bodies registered with CDSCO under MDR, 2017	Final
India	CDSCO	List of the Certified Medical Device Testing Laboratory (MDLT) under MDR, 2017	Final
India	CDSCO	Classification of Medical Device Pertaining to Rehabilitation under the Provisions of Medical Devices Rules 2017	Final
Malaysia	MDA	Harmonised borderline products in ASEAN (MDA/GD/0063), 1^st Edition	Final
Malaysia	MDA	Harmonised classification of medical devices in ASEAN (MDA/GD/0062), 1^st Edition	Final
Netherlands	CCMO	Overview of documents to be submitted for IVD performance studies	Final
Netherlands	CCMO	Flowchart - Adverse events in IVD performance studies	Final
Singapore	HSA	GN-35: Guidance on Special Access Routes (SAR) (Revision 3)	Final
Singapore	HSA	Request for unregistered medical device for use on patients by qualified practitioner/licensed healthcare facility (MDSA-HCP, Version 3)	Final
South Africa	SAHPRA	Guideline for borderline products (SAHPGL-CRO-01)	Draft
Switzerland	Swissmedic	Export Certificates	Final
Switzerland	Swissmedic	Information sheet – Swiss Single Registration Number (CHRN)	Final
Switzerland	Swissmedic	Information sheet – Service agreement for Swiss Single Registration Number (CHRN)	Final
Switzerland	Swissmedic	Information sheet – Clinical investigations with medical devices	Final
Switzerland	Swissmedic	Information sheet – FAQ Notifications	Final
Switzerland	Swissmedic	Information sheet – Performance studies with IVD	Final
Tanzania	TMDA	Guidelines on submission of application for change(s) to approved medical devices and in-vitro diagnostics (TMDA/DMD/MDA/G/003), First edition	Final
Tanzania	TMDA	Guidelines for notification of medical devices exempted from registration (TMDA/DMD/MDA/G/004), First edition	Final
UK	MHRA	MHRA fees	Final
UK	MHRA	Medical devices: UK approved bodies	Final
US	FDA	Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions – Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices – Guidance for Industry and FDA Staff	Final
US	FDA	Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products – Guidance for Industry and Food and Drug Administration Staff	Final

Global Medtech Guidance Tracker: August 2022

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