Country	Organization	Document	Status
International	IMDRF	Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity (IMDRF/CYBER WG/N73DRAFT:2022)	Draft
International	IMDRF	Marketing Review Report Work Instruction (IMDRF/GRRP WG (PD1)/N71 Draft:2022)	Draft
Australia	TGA	Guidance on applying the 2021 Advertising Code rules: Part 4 - Mandatory statements and other required information, Part 5 - Additional requirements for advertisements about particular therapeutic goods (Version 1.0)	Final
Australia	TGA	Testimonials and endorsements in advertising - Guidance on applying the Therapeutic Goods Advertising Code 2021 (Version 1.0)	Final
Australia	TGA	Guidance on applying the 2021 Advertising Code rules: Part 7 – Samples and incentives; Part 8 – Restricted representations; Part 9 – Price information (Version 1.0)	Final
Australia	TGA	Uniform Recall Procedure for Therapeutic Goods (URPTG) (Version 2.3)	Final
Australia	TGA	Important annual charge deadlines	Final
Australia	TGA	Fees and charges: summary - From 1 July 2022 (Version 1)	Final
Australia	TGA	Clinical evidence guidelines for medical devices (Version 3.1)	Final
Australia	TGA	Six monthly report - supply of unapproved therapeutic goods: A step-by-step guide to completing the form (Version 1.0)	Final
Canada	HC	Proposed Changes to the Medical Devices Directorate’s List of Recognized Standards for Medical Devices	Draft
Denmark	DMA	Manufacturers' reporting of incidents with medical devices	Final
EU	CAMD	Questions and Answers on Certificates of Free Sale and Article 60 of Regulation (EU) 2017/745	Final
EU	CAMD	Statement on transition to the Medical Devices Regulation (MDR) and the capacity of the medical device system	Final
EU	EC	Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746	Final
EU	MDCG	MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements	Final
EU	EMA	Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics (EMA/198592/2022)	Final
EU	EMA	Questions & Answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies (EMA/619893/2022)	Final
EU	EMA	Application form for initial consultation by a notified body on a companion diagnostic (EMA/579578/2022)	Final
EU	EMA	Application form for follow-up consultation procedure by a notified body on a companion diagnostic (EMA/579577/2022)	Final
EU	EMA	Consultation on companion diagnostic - Assessment report template	Final
India	CDSCO	Classification of Medical Device Pertaining to Obstetrical and Gynecological Under the provision of Medical Devices Rules 2017	Final
India	CDSCO	Classification of Medical Device Pertaining to Dental Under the provision of Medical Devices Rules 2017	Final
India	CDSCO	Final General Statutory Rules (GSR) 450(E) To amend Fourth Schedule wrt TSE or BSE certificate under MDR	Final
Ireland	HPRA	Guide to Performance Studies Conducted in Ireland (AUT-G0176-2)	Final
Ireland	HPRA	Forms & Applications: Notification of a Performance Study for a Companion Diagnostic using left-over samples under Article 58(2) IVDR	Final
Ireland	HPRA	Forms & Applications: Notification of a Performance Study of a CE Marked IVD (Article 70 IVDR)	Final
Ireland	HPRA	Forms & Applications: Notification of substantial modification of a clinical investigation of a medical device	Final
Ireland	HPRA	Forms & Applications: Application for certificates for free sale (IVDD medical devices, up classified and legacy devices)	Final
Malaysia	MDA	Licensing for establishment (MDA/GD/0027), 2nd Edition	Draft
Malaysia	MDA	Guideline for re-registration of registered medical device (MDA/GL/08)	Final
New Zealand	Medsafe	Schedule of Fees Payable under the Medicines Act 1981 (Effective from 1 July 2022)	Final
FDA Philippines	Philippines	Banning of all Mercury-Added Thermometers, Sphygmomanometers, Dental Amalgam Capsules and Liquid Mercury for Use in Dental Restorative Purposes (FDA Circular No.2022-003)	Final
Saudi Arabia	Saudi FDA	Requirements for Unique Device Identification (UDI) for Medical Devices (MDS – REQ 7) (Version 4.0)	Final
Singapore	HSA	Frequently asked questions (FAQs): Medical Device UDI System	Final
Singapore	HSA	GN-32: Guidance for Importation of Unregistered Medical Devices for Exhibition in Singapore (Revision 4)	Final
Singapore	HSA	FORM 32-A Application for importation of unregistered medical devices for exhibition	Final
South Africa	SAHPRA	Guideline for release of import health products at ports of entry (Version 2)	Final
South Africa	SAHPRA	Guidelines for advertisement of medicines and health products (Version 2)	Final
South Africa	SAHPRA	Guidelines for disposal of undesirable pharmaceutical products	Final
Tanzania	TMDA	Notice to all medical devices and diagnostics dealers on the deactivation of multiple trader accounts and the use of a single account in the online portal	Final
US	FDA	Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures: Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	Electromagnetic Compatibility (EMC) of Medical Devices - Guidance for Industry and Food and Drug Administration Staff	Final

Global Medtech Guidance Tracker: June 2022

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