Country	Organization	Document	Status
International	WHO	Guidance for best practices for clinical trials	Final
International	WHO	Instructions and requirements for Emergency Use Listing (EUL) Submission: In vitro diagnostics detecting Monkeypox virus nucleic acid	Final
International	GHWP	Guidance Document for Medical Device Organisations - Product Localisation for Manufacturing and Importation (GHWP/WG7/PD002:2024)	Draft
International	GHWP	Comparison study of new ISO13485 vs. QMS requirements in GHWP member economies (GHWP/WG7/PD001:2024)	Draft
International	GHWP	Software as a Medical Device (SaMD) PreMarket Submission Requirement – Comparison of requirement from Key jurisdictions (GHWP/WG3/PD002:2024)	Draft
Australia	TGA	Clarifying and strengthening the regulation of Artificial Intelligence (AI)	Draft
Canada	Health Canada	Policy on Drug/Medical Device Combination Products - Decisions	Final
Egypt	EDA	Guideline for Good Regulatory Oversight of Trials by the Egyptian Drug Authority (Version 3)	Final
EU	MDCG	MDCG 2021-4 rev.1 - Application of transitional provisions for certification of class D in vitro diagnostic medical devices under Reg (EU) 2017/746	Final
EU	TEAM-NB	Transition to the Implementation of Class D oversight by European Reference Laboratories (EURLs)	Final
EU	TEAM-NB	Team-NB Position Paper: Transfer Agreement for Surveillance of Legacy Devices specifying the terms of the transfer of the appropriate surveillance activities according to Article 110 (3e) of Regulation (EU) 2017/7461 in respect of legacy devices covered by a certificate issued in accordance with Directive 98/79/EC (Version 1)	Final
EU	TEAM-NB	Code of Conduct for Notified Bodies under Regulations (EU) 2017/745 and (EU) 2017/746 (Version 5.0)	Final
Hong Kong	DoH	Overview of the Medical Device Administrative Control System (GN-01:2024-4(E))	Final
India	CDSCO	Guidelines for Good Clinical Practices (GCP)	Draft
India	DoP	Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 2024	Final
Ireland	HPRA	Annual Review and Proposal for Fees – Financial Year 2025: Human Medicines, Compliance Activities, Blood, Tissue Establishments and Organs and Medical Devices	Draft
Pakistan	DRAP	Guidelines on national pharmacovigilance system (PHSR/GL/NP/001), 3rd Edition	Draft
Pakistan	DRAP	Checklist for the Inspection of Establishment license to Import Medical Device (Good Storage practices)	Final
South Africa	SAHPRA	Mpox Diagnostic Tests	Final
South Africa	SAHPRA	Form - Licence Application To Wholesale Medical Devices (Version 4)	Final
South Africa	SAHPRA	Form - Licence Application to Import, Distribute or Export Medical Devices (Version 4)	Final
South Africa	SAHPRA	Form - Licence Application to Manufacture, Import, Distribute or Export Medical Devices (Version 4)	Final
Switzerland	Swissmedic	swissdamed: Deadline on 13 November 2024	Final
Switzerland	Swissmedic	Request to review devices that comply with the old legislation	Final
Switzerland	Swissmedic	Guidance document - Expert Certificates (Version 3.4)	Final
Switzerland	swissethics	Template for a Clinical Investigation Plan (CIP) for clinical investigations involving Medical Devices (MD) (Version 3.0)	Final
Switzerland	swissethics	Template for an In vitro diagnostic (IVD) medical device Clinical Performance Study Plan (CPSP) (Version 2.0)	Final
Switzerland	swissethics	Template - Insurance for Clinical Trials	Final
UK	MHRA	MHRA consultation on statutory fees - proposals on ongoing cost recovery (Version 1.2)	Draft
UK	MHRA	Clinical investigations guidance	Final
UK	MHRA	AI Airlock pilot call for applications	Final
UK	MHRA	Application route for performance studies under the In Vitro Diagnostics Regulations in Northern Ireland	Final
US	FDA	Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle - Draft Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties	Draft
US	FDA	Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program - Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff	Draft
US	FDA	Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program - Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff	Draft
US	FDA	The Accreditation Scheme for Conformity Assessment (ASCA) Program - Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff	Draft
US	FDA	Chemical Analysis for Biocompatibility Assessment of Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff	Draft
US	FDA	Conducting Clinical Trials With Decentralized Elements - Guidance for Industry, Investigators, and Other Interested Parties	Final
US	FDA	Data Standards Catalog (Version 10.4)	Final
US	FDA	Air Powered Dental Handpieces and Air Motors - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	Dental Cements - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	Dental Ceramics - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	Dental Impression Materials - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment - Guidance for Industry and Food and Drug Administration Staff	Final
US	FDA	Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders - Guidance for Mammography Facilities and Food and Drug Administration Staff	Final

Global Medtech Guidance Tracker: September 2024

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