Country	Organization	Document	Status
International	GHWP	Regulatory mechanism for Medical Devices including In Vitro Diagnostic Medical Devices and Software as Medical Devices during a public health emergency (GHWP/WG2-WG1-WG3/PF001:2021)	Draft
International	GHWP	Replacement Reagent and Instrument Family Policy (AHWP/WG2/PF001:2021)	Draft
International	GHWP	Clinical Evidence for IVD Medical Devices - Clinical Performance Studies for In Vitro Diagnostic Medical Devices (AHWP/WG2-WG5/PF001:2021)	Draft
Australia	TGA	Medical device patient information leaflets and implant cards (including acceptance of Implementation Plans) (Version 1.7)	Final
Australia	TGA	Guidance on the regulation of listed disinfectants in Australia (Version 2.0)	Final
Australia	TGA	Disinfectants: FAQ for new sponsors	Final
Australia	TGA	Essential Principles - consent for noncompliance	Final
Australia	TGA	Guidance for consent application form on the TGA Business Services (TBS) portal (Version 1.1)	Final
Australia	TGA	Consent for Non-compliant Medical Device(s) - Frequently Asked Questions	Final
Australia	TGA	Software-based medical devices FAQs	Final
Australia	TGA	New Therapeutic Goods Advertising Code 1 January 2022	Final
Australia	TGA	Guidance on applying the Advertising Code rules	Final
Canada	HC	Interim enforcement approach for federal, provincial and territorial COVID-19 testing initiatives	Final
Canada	HC	What MDEL holders need to know about annual licence review for 2022	Final
Canada	HC	Failure to pay 2021 annual licence review fees will result in cancellation of MDELs	Final
Denmark	DMA	Certificates of Free Sale to Danish manufacturers of medical devices	Final
EU	EMA	Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics (EMA/747623/2021)	Draft
EU	EMA	Questions & Answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies (EMA/708170/2021)	Final
EU	EMA	Application form for consultation by a notified body on a companion diagnostic (EMA/755952/2021)	Final
EU	EMA	Consultation on companion diagnostic - Assessment report template	Final
EU	MDCG	MDCG 2021-28 - Substantial modification of clinical investigation under Medical Device Regulation	Final
EU	MDCG	MDCG 2021-27 - Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746	Final
EU	EC	Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices	Final
EU	EC	Transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices	Final
Ghana	FDA Ghana	Renewal policy for FDA approvals	Final
India	CDSCO	List of certified Medical Device Testing Laboratory (MDLT) under MDR	Final
Japan	PMDA	Publication of the Medical Device Adverse Event Terminology Based on the IMDRF Adverse Event Terminology	Final
Japan	PMDA	Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Medical Devices (Provisional Translation as of December 2021)	Final
Pakistan	DRAP	User guide for online import/export applications software (MISC/GL/IE/001)	Final
Pakistan	DRAP	Certificate of Good Manufacturing Practices (GMP) for establishments manufacturing medical devices: Policy Board decision	Final
Pakistan	DRAP	Statutory Regulatory Order (SRO) 1472(I)/2021 - Ethical Marketing to Healthcare Professionals Rules, 2021	Final
Philippines	FDA Philippines	Amendment to FDA Circular No. 2021-023 Re: Extension of Validity of Selected Special Certification for COVID-19 Test Kits Under FDA Memorandum No. 2020-006 entitled “Issuance of Special Certification for Imported Test Kits of COVID-19”	Final
Philippines	FDA Philippines	Guidelines for Application of Authorizations at the Food and Drug Administration in Light of the Extended State of Public Health Emergency (FDA Circular No.2021-0025)	Final
Philippines	FDA Philippines	Categorization of identified borderline health products under the jurisdiction of the food and drug administration	Draft
Saudi Arabia	Saudi FDA	Requirements for Medical Devices Marketing Authorization (MDS-REQ 1) (Version 6.0)	Final
Saudi Arabia	Saudi FDA	Requirements for Clinical Trials of Medical Devices (MDS-REQ 2) (Version 4)	Final
Saudi Arabia	Saudi FDA	Form - Declaration of Conformity (DOC) to “Medical Devices Law” and its Executive Regulation	Final
Saudi Arabia	Saudi FDA	Form - Innovative Medical Device Summary Form	Final
Singapore	HSA	Product Owner Information in Medical Device Information Communication System (MEDICS)	Final
Singapore	HSA	COVID-19 Test Kits Authorised for Professional Use	Final
Switzerland	Swissmedic	Practical interpretation – Requirements for importers under the Medical Devices Ordinance in the case of combination products	Final
Switzerland	Swissmedic	Update of the information sheet on the obligations of economic operators	Final
Switzerland	Swissmedic	FSN requirements for publication: Manufacturers & authorised representatives	Final
Switzerland	Swissmedic	New form for notification for mandate as Swiss authorised representative (CH-REP)	Final
Switzerland	Swissmedic	FAQ - Notification of medical devices	Final
UK	MHRA	Regulating medical devices in the UK	Final
UK	MHRA	Register medical devices to place on the market	Final
UK	MHRA	Guidance for manufacturers: diagnostic assurance with SARS-CoV-2 variants in circulation	Final
UK	MHRA	Regulatory status of software (including apps) used in the diagnosis, treatment and management of patients with coronavirus (COVID-19)	Final
UK	MHRA	Advice for manufacturers: software and apps used in COVID-19 pandemic	Final
US	FDA	Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions - Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology - Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Referencing the Definition of 'Device' in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents - Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Digital Health Technologies for Remote Data Acquisition in Clinical Investigations - Guidance for Industry, Investigators, and Other Stakeholders	Draft
US	FDA	Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH) - Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff	Final

Global Medtech Guidance Tracker: December 2021

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